Trial Outcomes & Findings for Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS (NCT NCT01626079)

NCT ID: NCT01626079

Last Updated: 2023-11-27

Results Overview

Percentage of Participants with Freedom from Device related Complications at 12 Months. Composite of Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, and any device related complications requiring non-elective cardiovascular surgery.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 776 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2023-11-27

Participant Flow

In COAPT, 614 subjects were randomized. Enrollment concluded on June 23, 2017. Of the 614 randomized subjects, 302 were in Device group and 312 in the Control group. Subject follow-up is complete in the COAPT IDE study. In COAPT CAS Group, 162 new subjects were enrolled. All 162 subjects received MitraClip device. Enrollment concluded in March 2019. Subject follow-up is on-going in the COAPT CAS study. Total enrollment = 614 (COAPT = 302 MitraClip + 314 Control) + 162 (COAPT CAS) = 776

This section includes the results for the primary safety, primary effectiveness, and the 10 secondary endpoints that are the most essential outcomes of the COAPT trial and also the Primary safety, primary effectiveness and other endpoints for the COAPT CAS Group.

Participant milestones

Measure	MitraClip System Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.	COAPT CAS Group 162 Subjects enrolled in the COAPT Continued access study (CAS) group. Subject follow-up until occurred until 12-month visit.
Overall Study STARTED	302	312	162
Overall Study COMPLETED	104	75	110
Overall Study NOT COMPLETED	198	237	52

Reasons for withdrawal

Measure	MitraClip System Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.	COAPT CAS Group 162 Subjects enrolled in the COAPT Continued access study (CAS) group. Subject follow-up until occurred until 12-month visit.
Overall Study Death	167	192	39
Overall Study Withdrawal by Subject	23	37	5
Overall Study Lost to Follow-up	7	4	2
Overall Study Missed Visits	1	4	6

Baseline Characteristics

Data is missing for 1 subject in Device group and 6 subjects in control group

Baseline characteristics by cohort

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.	COAPT CAS Group n=162 Participants subjects who received Percutaneous mitral valve repair using MitraClip System in the COAPT continued access study (CAS) group.	Total n=776 Participants Total of all reporting groups
New York Heart Association (NYHA) Classification NYHA Class II	129 Participants n=302 Participants	110 Participants n=312 Participants	30 Participants n=162 Participants	269 Participants n=776 Participants
Age, Continuous	71.7 years STANDARD_DEVIATION 11.8 • n=302 Participants	72.8 years STANDARD_DEVIATION 10.5 • n=312 Participants	74.5 years STANDARD_DEVIATION 10.3 • n=162 Participants	72.2 years STANDARD_DEVIATION 11.2 • n=776 Participants
Sex: Female, Male Female	101 Participants n=302 Participants	120 Participants n=312 Participants	57 Participants n=162 Participants	278 Participants n=776 Participants
Sex: Female, Male Male	201 Participants n=302 Participants	192 Participants n=312 Participants	105 Participants n=162 Participants	498 Participants n=776 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian or Alaska Native	0 Participants n=302 Participants	0 Participants n=312 Participants	0 Participants n=162 Participants	0 Participants n=776 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	6 Participants n=302 Participants	12 Participants n=312 Participants	5 Participants n=162 Participants	23 Participants n=776 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black or African American	44 Participants n=302 Participants	44 Participants n=312 Participants	28 Participants n=162 Participants	116 Participants n=776 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic or Latino	20 Participants n=302 Participants	20 Participants n=312 Participants	0 Participants n=162 Participants	40 Participants n=776 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native Hawaiian or Other Pacific Islander	1 Participants n=302 Participants	0 Participants n=312 Participants	0 Participants n=162 Participants	1 Participants n=776 Participants
Race/Ethnicity, Customized Race/Ethnicity · White or Caucasian	225 Participants n=302 Participants	232 Participants n=312 Participants	129 Participants n=162 Participants	586 Participants n=776 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	6 Participants n=302 Participants	4 Participants n=312 Participants	0 Participants n=162 Participants	10 Participants n=776 Participants
Region of Enrollment Canada	12 participants n=302 Participants	14 participants n=312 Participants	0 participants n=162 Participants	26 participants n=776 Participants
Region of Enrollment United States	290 participants n=302 Participants	298 participants n=312 Participants	162 participants n=162 Participants	588 participants n=776 Participants
Height	170.84 Cm STANDARD_DEVIATION 10.35 • n=301 Participants • Data is missing for 1 subject in Device group and 6 subjects in control group	169.86 Cm STANDARD_DEVIATION 10.75 • n=306 Participants • Data is missing for 1 subject in Device group and 6 subjects in control group	171.11 Cm STANDARD_DEVIATION 10.38 • n=162 Participants • Data is missing for 1 subject in Device group and 6 subjects in control group	170.34 Cm STANDARD_DEVIATION 10.56 • n=769 Participants • Data is missing for 1 subject in Device group and 6 subjects in control group
Weight	78.79 Kg STANDARD_DEVIATION 17.23 • n=301 Participants • Data is missing for 1 subject in Device group and 5 subjects in Control group.	78.40 Kg STANDARD_DEVIATION 20.06 • n=307 Participants • Data is missing for 1 subject in Device group and 5 subjects in Control group.	79.08 Kg STANDARD_DEVIATION 18.76 • n=162 Participants • Data is missing for 1 subject in Device group and 5 subjects in Control group.	78.59 Kg STANDARD_DEVIATION 18.70 • n=770 Participants • Data is missing for 1 subject in Device group and 5 subjects in Control group.
Body Mass Index (kg/m^2)	27.04 Kg/m^2 STANDARD_DEVIATION 5.81 • n=301 Participants • Data is missing for 2 subjects for Device and 7 subjects for Control group.	27.05 Kg/m^2 STANDARD_DEVIATION 5.96 • n=305 Participants • Data is missing for 2 subjects for Device and 7 subjects for Control group.	26.93 Kg/m^2 STANDARD_DEVIATION 5.63 • n=162 Participants • Data is missing for 2 subjects for Device and 7 subjects for Control group.	27.05 Kg/m^2 STANDARD_DEVIATION 5.88 • n=768 Participants • Data is missing for 2 subjects for Device and 7 subjects for Control group.
Serum Creatinine (mg/dL)	1.77 (mg/dL) STANDARD_DEVIATION 1.22 • n=300 Participants • Data is missing for 2 subjects in Device group and 6 subjects in Control group.	1.80 (mg/dL) STANDARD_DEVIATION 1.42 • n=306 Participants • Data is missing for 2 subjects in Device group and 6 subjects in Control group.	1.93 (mg/dL) STANDARD_DEVIATION 1.54 • n=162 Participants • Data is missing for 2 subjects in Device group and 6 subjects in Control group.	1.79 (mg/dL) STANDARD_DEVIATION 1.32 • n=768 Participants • Data is missing for 2 subjects in Device group and 6 subjects in Control group.
Creatinine Clearance (mL/min)	50.87 mL/min STANDARD_DEVIATION 28.48 • n=299 Participants • Data is missing for 3 subjects in Device group and 10 subjects in Control group.	47.76 mL/min STANDARD_DEVIATION 24.97 • n=302 Participants • Data is missing for 3 subjects in Device group and 10 subjects in Control group.	0 mL/min STANDARD_DEVIATION 0 • n=162 Participants • Data is missing for 3 subjects in Device group and 10 subjects in Control group.	49.31 mL/min STANDARD_DEVIATION 26.79 • n=763 Participants • Data is missing for 3 subjects in Device group and 10 subjects in Control group.
Creatinine Clearance <= 60mL/min	214 Participants n=299 Participants • Data is missing for 3 subjects in Device group and 10 subjects in Control group	227 Participants n=302 Participants • Data is missing for 3 subjects in Device group and 10 subjects in Control group	0 Participants n=162 Participants • Data is missing for 3 subjects in Device group and 10 subjects in Control group	441 Participants n=763 Participants • Data is missing for 3 subjects in Device group and 10 subjects in Control group
Brain Natriuretic Peptide (Pg/mL)	1014.77 Pg/mL STANDARD_DEVIATION 1085.98 • n=208 Participants • Not all subjects had Brain Natriuretic Peptide (BNP) value collected. some subjects were on NT-proBNP.	1017.13 Pg/mL STANDARD_DEVIATION 1212.77 • n=209 Participants • Not all subjects had Brain Natriuretic Peptide (BNP) value collected. some subjects were on NT-proBNP.	1224.2 Pg/mL STANDARD_DEVIATION 1270.4 • n=162 Participants • Not all subjects had Brain Natriuretic Peptide (BNP) value collected. some subjects were on NT-proBNP.	1015.95 Pg/mL STANDARD_DEVIATION 1149.89 • n=579 Participants • Not all subjects had Brain Natriuretic Peptide (BNP) value collected. some subjects were on NT-proBNP.
NT-proBNP (pg/mL)	5174.33 pg/mL STANDARD_DEVIATION 6566.61 • n=74 Participants • Majority of subjects had BNP available. Subjects who did not have BNP had NT-proBNP available.	5943.86 pg/mL STANDARD_DEVIATION 8437.61 • n=85 Participants • Majority of subjects had BNP available. Subjects who did not have BNP had NT-proBNP available.	6885.3 pg/mL STANDARD_DEVIATION 8287.0 • n=162 Participants • Majority of subjects had BNP available. Subjects who did not have BNP had NT-proBNP available.	5585.71 pg/mL STANDARD_DEVIATION 7610.56 • n=321 Participants • Majority of subjects had BNP available. Subjects who did not have BNP had NT-proBNP available.
Elevated BNP or NT-BNP prior to Enrollment	267 Participants n=286 Participants • All available data reported	282 Participants n=303 Participants • All available data reported	0 Participants n=162 Participants • All available data reported	549 Participants n=751 Participants • All available data reported
Extremely High Risk for MV Surgery	205 Participants n=299 Participants • Not all subjects met the criteria for High Risk for MV Surgery	218 Participants n=312 Participants • Not all subjects met the criteria for High Risk for MV Surgery	0 Participants n=162 Participants • Not all subjects met the criteria for High Risk for MV Surgery	423 Participants n=773 Participants • Not all subjects met the criteria for High Risk for MV Surgery
Diabetes	106 Participants n=302 Participants	123 Participants n=312 Participants	51 Participants n=162 Participants	280 Participants n=776 Participants
Hypertension	243 Participants n=302 Participants	251 Participants n=312 Participants	137 Participants n=162 Participants	631 Participants n=776 Participants
Hypercholesterolemia	166 Participants n=302 Participants	163 Participants n=312 Participants	0 Participants n=162 Participants	329 Participants n=776 Participants
Previous Myocardial Infarction	156 Participants n=302 Participants	160 Participants n=312 Participants	65 Participants n=162 Participants	381 Participants n=776 Participants
Previous Percutaneous Coronary Intervention	130 Participants n=302 Participants	153 Participants n=312 Participants	63 Participants n=162 Participants	346 Participants n=776 Participants
Previous Coronary Artery Bypass Grafting	121 Participants n=302 Participants	126 Participants n=312 Participants	51 Participants n=162 Participants	298 Participants n=776 Participants
Previous Stroke or Transient Ischemic Attack	56 Participants n=302 Participants	49 Participants n=312 Participants	9 Participants n=162 Participants	114 Participants n=776 Participants
Peripheral Vascular Disease	52 Participants n=302 Participants	57 Participants n=312 Participants	34 Participants n=162 Participants	143 Participants n=776 Participants
Chronic Obstructive Pulmonary Disease	71 Participants n=302 Participants	72 Participants n=312 Participants	0 Participants n=162 Participants	143 Participants n=776 Participants
History of Atrial Fibrillation or Flutter	173 Participants n=302 Participants	166 Participants n=312 Participants	99 Participants n=162 Participants	438 Participants n=776 Participants
Anemia	180 Participants n=301 Participants • All available data is reported	192 Participants n=306 Participants • All available data is reported	0 Participants n=162 Participants • All available data is reported	372 Participants n=769 Participants • All available data is reported
STS Risk Score	7.83 percentage of expected mortality STANDARD_DEVIATION 5.53 • n=302 Participants	8.5 percentage of expected mortality STANDARD_DEVIATION 6.15 • n=312 Participants	9.26 percentage of expected mortality STANDARD_DEVIATION 6.39 • n=162 Participants	8.17 percentage of expected mortality STANDARD_DEVIATION 5.86 • n=776 Participants
STS Risk Score >= 8%	126 Participants n=302 Participants	136 Participants n=312 Participants	78 Participants n=162 Participants	340 Participants n=776 Participants
Risk of Surgery-related complications or death High	205 Participants n=299 Participants • All available data is reported	218 Participants n=312 Participants • All available data is reported	0 Participants n=162 Participants • All available data is reported	423 Participants n=773 Participants • All available data is reported
Risk of Surgery-related complications or death Not High	94 Participants n=299 Participants • All available data is reported	94 Participants n=312 Participants • All available data is reported	0 Participants n=162 Participants • All available data is reported	188 Participants n=773 Participants • All available data is reported
Cardiomyopathy Ischemic	184 Participants n=302 Participants	189 Participants n=312 Participants	73 Participants n=162 Participants	446 Participants n=776 Participants
Cardiomyopathy Non-Ischemic	118 Participants n=302 Participants	123 Participants n=312 Participants	66 Participants n=162 Participants	307 Participants n=776 Participants
New York Heart Association (NYHA) Classification NYHA Class I	1 Participants n=302 Participants	0 Participants n=312 Participants	0 Participants n=162 Participants	1 Participants n=776 Participants
New York Heart Association (NYHA) Classification NYHA Class III	154 Participants n=302 Participants	168 Participants n=312 Participants	111 Participants n=162 Participants	433 Participants n=776 Participants
New York Heart Association (NYHA) Classification NYHA Class IVa, ambulatory	18 Participants n=302 Participants	33 Participants n=312 Participants	21 Participants n=162 Participants	72 Participants n=776 Participants
Hospitalization for Heart Failure within Previous 1 yr	176 Participants n=302 Participants	175 Participants n=312 Participants	105 Participants n=162 Participants	456 Participants n=776 Participants
Previous Cardiac Resynchronization Therapy	115 Participants n=302 Participants	109 Participants n=312 Participants	25 Participants n=162 Participants	249 Participants n=776 Participants
Previous Implantation of Defibrillator	91 Participants n=302 Participants	101 Participants n=312 Participants	95 Participants n=162 Participants	287 Participants n=776 Participants
Severity of Mitral Regurgitation Moderate-to-severe, grade 3+	148 Participants n=302 Participants • In the Control group, baseline echocardiography data was not readable. Hence 311 participants were analyzed.	172 Participants n=311 Participants • In the Control group, baseline echocardiography data was not readable. Hence 311 participants were analyzed.	54 Participants n=162 Participants • In the Control group, baseline echocardiography data was not readable. Hence 311 participants were analyzed.	374 Participants n=775 Participants • In the Control group, baseline echocardiography data was not readable. Hence 311 participants were analyzed.
Severity of Mitral Regurgitation Severe, grade 4+	154 Participants n=302 Participants • In the Control group, baseline echocardiography data was not readable. Hence 311 participants were analyzed.	139 Participants n=311 Participants • In the Control group, baseline echocardiography data was not readable. Hence 311 participants were analyzed.	99 Participants n=162 Participants • In the Control group, baseline echocardiography data was not readable. Hence 311 participants were analyzed.	392 Participants n=775 Participants • In the Control group, baseline echocardiography data was not readable. Hence 311 participants were analyzed.
Effective Regurgitat Orifice Area	0.41 Cm2 STANDARD_DEVIATION 0.15 • n=289 Participants • EROA was not measurable for all subjects	0.40 Cm2 STANDARD_DEVIATION 0.15 • n=302 Participants • EROA was not measurable for all subjects	0.70 Cm2 STANDARD_DEVIATION 1.16 • n=162 Participants • EROA was not measurable for all subjects	0.41 Cm2 STANDARD_DEVIATION 0.15 • n=753 Participants • EROA was not measurable for all subjects
Left Ventricular End Systolic Dimension (Diameter)	5.28 cm STANDARD_DEVIATION 0.86 • n=301 Participants • LVESD was not measurable for all subjects	5.30 cm STANDARD_DEVIATION 0.89 • n=306 Participants • LVESD was not measurable for all subjects	1.16 cm STANDARD_DEVIATION 0.95 • n=162 Participants • LVESD was not measurable for all subjects	5.29 cm STANDARD_DEVIATION 0.87 • n=769 Participants • LVESD was not measurable for all subjects
Left Ventricular End-Diastolic Dimension	6.17 cm STANDARD_DEVIATION 0.73 • n=301 Participants • LVEDD was not measurable in all subjects	6.19 cm STANDARD_DEVIATION 0.75 • n=307 Participants • LVEDD was not measurable in all subjects	6.23 cm STANDARD_DEVIATION 0.86 • n=162 Participants • LVEDD was not measurable in all subjects	6.18 cm STANDARD_DEVIATION 0.74 • n=770 Participants • LVEDD was not measurable in all subjects
Left Ventricular End-Systolic Volume	135.5 mL STANDARD_DEVIATION 56.1 • n=281 Participants • LVESV was not measurable for all subjects	134.3 mL STANDARD_DEVIATION 60.3 • n=294 Participants • LVESV was not measurable for all subjects	132.3 mL STANDARD_DEVIATION 65.4 • n=162 Participants • LVESV was not measurable for all subjects	134.9 mL STANDARD_DEVIATION 58.2 • n=737 Participants • LVESV was not measurable for all subjects
Left Ventricular End-Diastolic Volume	194.4 mL STANDARD_DEVIATION 69.2 • n=281 Participants • LVEDV was not measurable in all subjects	191.0 mL STANDARD_DEVIATION 72.9 • n=294 Participants • LVEDV was not measurable in all subjects	185.8 mL STANDARD_DEVIATION 81.2 • n=162 Participants • LVEDV was not measurable in all subjects	192.7 mL STANDARD_DEVIATION 71.0 • n=737 Participants • LVEDV was not measurable in all subjects
Left Ventricular Ejection Fraction	31.32 % STANDARD_DEVIATION 9.07 • n=281 Participants • LVEF was not measured for all subjects	31.30 % STANDARD_DEVIATION 9.58 • n=294 Participants • LVEF was not measured for all subjects	32.2 % STANDARD_DEVIATION 9.9 • n=162 Participants • LVEF was not measured for all subjects	31.31 % STANDARD_DEVIATION 9.32 • n=737 Participants • LVEF was not measured for all subjects
LVEF >= 40%	231 Participants n=281 Participants • All available data is reported	241 Participants n=294 Participants • All available data is reported	28 Participants n=162 Participants • All available data is reported	500 Participants n=737 Participants • All available data is reported
Right Ventricular Systolic Pressure	43.95 mmHg STANDARD_DEVIATION 13.44 • n=253 Participants • All available data is reported	44.56 mmHg STANDARD_DEVIATION 13.96 • n=275 Participants • All available data is reported	0 mmHg STANDARD_DEVIATION 0 • n=162 Participants • All available data is reported	44.26 mmHg STANDARD_DEVIATION 13.70 • n=690 Participants • All available data is reported

PRIMARY outcome

Timeframe: 12 months

Population: Subjects who were randomized with attempted procedure to the device group with available data. Performance goal was 88%.

Percentage of Participants with Freedom from Device related Complications at 12 Months.

Composite of Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, and any device related complications requiring non-elective cardiovascular surgery.

Outcome measures

Measure	MitraClip System n=293 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Primary Safety Endpoint - Percentage of Participants With Freedom From Device Related Complications at 12 Months	0.966 percentage of participants Interval 0.948 to Upper limit is NA as this is a one sided 95% confidence interval.	—

PRIMARY outcome

Timeframe: 24 months

Population: 302 subjects from device group and 312 subjects from the control group were analyzed for Recurrent HF hospitalizations through 24 months

Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Primary Effectiveness Endpoint	160 events	283 events

PRIMARY outcome

Timeframe: 24 months

Population: 302 subjects from device group and 312 subjects from the control group were analyzed for Recurrent HF hospitalizations through 24 months

Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Primary Effectiveness Endpoint	92 Participants	151 Participants

SECONDARY outcome

Timeframe: 12 months

Population: A total of 162 subjects were enrolled in the COAPT CAS study.

Number of recurrent Heart Failure hospitalization events at 12 months.

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)	52 Events	—

SECONDARY outcome

Timeframe: 12 months

Population: A total of 162 subjects were enrolled in the COAPT CAS study. Of them NYHA data was available for a total of 93 subjects at 12 months.

The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.

Outcome measures

Measure	MitraClip System n=93 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) NYHA Class I	21 Participants	—
New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) NYHA Class II	44 Participants	—
New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) NYHA Class III	23 Participants	—
New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) NYHA Class IV	5 Participants	—

SECONDARY outcome

Timeframe: 30 days

Population: A total of 162 subjects were enrolled in the COAPT CAS study. Of them NYHA data was available for a total of 142 subjects at 30 days.

The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.

Outcome measures

Measure	MitraClip System n=142 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) NYHA Class I	30 Participants	—
New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) NYHA Class II	66 Participants	—
New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) NYHA Class III	43 Participants	—
New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) NYHA Class IV	3 Participants	—

SECONDARY outcome

Timeframe: 12 months

Population: A total of 162 subjects were enrolled in the COAPT CAS study. Data was available for 93 subjects at 12 months.

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physicalfunction, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possiblesubscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies thefollowing six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical FunctionDomain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQSymptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Scoreincludes total symptom and physical function scores to correspond with NYHA Classification. Overall SummaryScore includes the total symptom, physical function, social limitations and quality of life scores.

Outcome measures

Measure	MitraClip System n=93 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	65.93 KCCQ Score on a points scale Standard Deviation 23.80	—

SECONDARY outcome

Timeframe: 30 days

Population: A total of 162 subjects were enrolled in the COAPT CAS study. Data was available for 143 subjects at 30 days.

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

Outcome measures

Measure	MitraClip System n=143 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	61.36 KCCQ score on a points scale Standard Deviation 25.00	—

SECONDARY outcome

Timeframe: 12 months

Population: A total of 162 subjects were enrolled in the COAPT CAS study. 6MWT data was available for 72 subjects at 12 months.

The Six Minute Walk Test (6MWT) is a practical simple test that requires a 100-ft hallway but no exerciseequipment or advanced training for technicians. This test measures the distance that a patient can quickly walk ona flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of allthe systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation,peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific informationon the function of each of the different organs and systems involved in exercise or the mechanism of exerciselimitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses thesubmaximal level of functional capacity.

Outcome measures

Measure	MitraClip System n=72 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis)	219.87 meters Standard Deviation 124.82	—

SECONDARY outcome

Timeframe: 30 days

Population: A total of 162 subjects were enrolled in the COAPT CAS study. 6MWT data was available for 117 subjects at 30 days..

The Six Minute Walk Test (6MWT) is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.

Outcome measures

Measure	MitraClip System n=117 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis)	231.24 meters Standard Deviation 145.98	—

SECONDARY outcome

Timeframe: 12 months

Population: Echocardiogram data was available for 98 subjects at 12 months.

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Outcome measures

Measure	MitraClip System n=98 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) None or Trace/Trivial	9 Participants	—
Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) Mild (1+)	53 Participants	—
Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) Moderate (2+)	27 Participants	—
Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) Moderate - Severe (3+)	6 Participants	—
Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) Severe (4+)	3 Participants	—

SECONDARY outcome

Timeframe: 30 days

Population: Echocardiogram data was available for 149 subjects at 30 days.

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Outcome measures

Measure	MitraClip System n=149 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) None or Trace/Trivial	11 Participants	—
Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) Mild (1+)	85 Participants	—
Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) Moderate (2+)	40 Participants	—
Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) Moderate - Severe (3+)	9 Participants	—
Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) Severe (4+)	4 Participants	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis)	4 Participants	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis)	1 Participants	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Major Vascular Complications (COAPT CAS Study Analysis)	1 Participants	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Major Vascular Complications (COAPT CAS Study Analysis)	0 Participants	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis)	4 Participants	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis)	2 Participants	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis)	0 Participants	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis)	0 Participants	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Stroke (COAPT CAS Study Analysis)	1 Participants	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Stroke (COAPT CAS Study Analysis)	1 Participants	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Myocardial Infarction (MI) (COAPT CAS Study Analysis)	0 Participants	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Myocardial Infarction (MI) (COAPT CAS Study Analysis)	0 Participants	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Death and Primary Cause of Death (COAPT CAS Study Analysis) Cardiac	13 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Neurologic	2 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Renal	0 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Vascular	0 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Infection	1 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Valvular	0 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Unknown	24 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Other	1 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Not Available	1 Participants	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	MitraClip System n=162 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Death and Primary Cause of Death (COAPT CAS Study Analysis) Cardiac	2 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Neurologic	0 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Renal	0 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Vascular	0 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Infection	0 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Valvular	0 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Unknown	1 Participants	—
Death and Primary Cause of Death (COAPT CAS Study Analysis) Other	0 Participants	—

SECONDARY outcome

Timeframe: 30 days post-procedure in the Device group

Population: All device subjects

The percentage of patients free from the composite endpoint as described above.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Percentage of Patients Free From the Composite of All-cause Death, Stroke, MI, or Non-elective Cardiovascular Surgery for Device Related Complications in the Device Group	96.9 Percentage of Participants Interval 94.7 to 96.9	—

SECONDARY outcome

Timeframe: 12 months

Population: All device and control group subjects were included in the analysis.

Death from any cause mortality at 12months.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Deaths at 12 Months (All Cause Mortality)	57 participants	70 participants

SECONDARY outcome

Timeframe: 12 months

Population: Echocardiography data was available for 210 subjects in Device group and 175 subjects in Control group

MR severity grade of 2+ or lower at 12 months MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Outcome measures

Measure	MitraClip System n=210 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=175 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Participants With Mitral Regurgitation Severity Grade of 2+ or Lower at 12 Months	199 Participants	82 Participants

SECONDARY outcome

Timeframe: 12 months over baseline

Population: Analysis population includes subjects still active and with paired available compared to baseline.

The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.

Outcome measures

Measure	MitraClip System n=230 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=237 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in Distance Walked on the 6 Minute Walk Test (6MWT Distance or 6MWD)	-2.17 meters Standard Deviation 9.12	-60.2 meters Standard Deviation 8.99

SECONDARY outcome

Timeframe: 12 months over baseline

Population: Analysis population includes subjects still active and with paired available compared to baseline.

Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 12 month KCCQ score.

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score.

Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification.

Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

Outcome measures

Measure	MitraClip System n=237 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=228 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	12.5 KCCQ Score on a points scale Standard Deviation 1.8	-3.6 KCCQ Score on a points scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 12 months over baseline

Population: Analysis population includes subjects with echocardiography paired data available

Paired data comparing the Change in LVEDV at baseline vs 12 months

Outcome measures

Measure	MitraClip System n=175 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=174 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in Left Ventricular End Diastolic Volume (LVEDV)	-3.71 mL Standard Deviation 5.08	17.06 mL Standard Deviation 5.10

SECONDARY outcome

Timeframe: 12 months

Population: Analysis population includes subjects with available NYHA class data at 12 months

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA CLASS)

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Outcome measures

Measure	MitraClip System n=237 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=232 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Participants With New York Heart Association (NYHA) Functional Class I/II	171 Participants	115 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: All randomized subjects in Device and Control Group

Number of Recurrent Hospitalizations for any cause within 24 months.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Recurrent Hospitalizations - All Cause	474 Number of Events	610 Number of Events

SECONDARY outcome

Timeframe: 24 months

The win ratio is a useful method for providing an estimate of the treatment effect when composite endpoints are analyzed as the analysis accounts for clinical significance of the outcomes of interest. For example, in the composite of death and recurrent HF hospitalizations through 24 months, subjects in the Device and Control groups were formed into matched pairs, where each pair of subjects was classified into 1 of 5 outcomes scenarios:

A. Death in Device group first B. Death in Control group first C. More HF hospitalizations in the Device group (or in the case of a tie, the first HF hospitalization in the Device group occurs first) D. More HF hospitalization in the Control group (or in the case of tie, the first HF hospitalization in the Control group occurs first) E. None of the above In this way, the number of "Winners" in the Device group was NW = NB + ND while the number of "Losers" in the Device group was NL = NA + NC. The "Win Ratio" was then calculated as NW/NL.

Outcome measures

Measure	MitraClip System n=614 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Death or HF Hospitalization Within 24 Months (Finkelstein-Schoenfeld Analysis of All-Cause Death or Recurrent HF Hospitalization Through 24 Months)	1.61 Win Ratio Interval 1.29 to 2.04	—

SECONDARY outcome

Timeframe: 2 years

The COAPT study is still on-going. Only the Primary and major secondary endpoints have been entered. Rest of the results will be entered when the study ends in July 2024.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: Total number of subjects randomized in the Device and Control group

Death from any cause within 24 months - no of events

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From All-cause Mortality	83 no of events	125 no of events

OTHER_PRE_SPECIFIED outcome

Timeframe: Within and after 30 days of the procedure

Population: All available data has been reported.

Device or procedure-related adverse events are defined as adverse events that are adjudicated by the Clinical Events Committee as possibly, probably or definitely device and/or procedure-related, regardless of the temporal relationship to the MitraClip procedure. Device or procedure-related adverse events will be broken down into those that occur within 30 days of the procedure and those that occur after 30 days of the procedure. Examples of device-related adverse events are: myocardial perforation, Single Leaflet Device Attachment, embolization of the MitraClip device or MitraClip System components, iatrogenic atrial septal defect, mitral valve stenosis, need for mitral valve replacement instead of repair due at least in part to the MitraClip procedure or the presence of the MitraClip device.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Device or Procedure-Related Adverse Events Occurred within 30 days	17 Participants	—
Device or Procedure-Related Adverse Events Occurred between 31 days and 365 days	4 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Population: Subjects randomized to the device arm

Defined as the rate of successful delivery and deployment of the MitraClip device(s) with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Implant Rate	287 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Population: Device procedure time was not available for all implanted subjects. Data was available for 282 subjects from 302 randomized subjects in device arm.

Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed

Outcome measures

Measure	MitraClip System n=282 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Device Procedure Time	118.9 minutes Standard Deviation 63.5	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Population: Total procedure time was available for 293 subjects from the 302 subjects randomized to device arm.

Defined as the time elapsed from the first of any of the following: intravascular catheter placement, anesthesia or sedation, or transesophageal echocardiogram (TEE), to the removal of the last catheter and TEE

Outcome measures

Measure	MitraClip System n=293 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Total Procedure Time	162.9 minutes Standard Deviation 118.1	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Population: Device time available for all 287 subjects implanted with MitraClip.

Defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the MitraClip Delivery System (CDS) is retracted into the Steerable Guide Catheter

Outcome measures

Measure	MitraClip System n=287 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Device Time	82.7 minutes Standard Deviation 80.8	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Population: Fluoroscopy duration for all available subjects with MitraClip device

Defined as the duration of exposure to fluoroscopy during the MitraClip procedure

Outcome measures

Measure	MitraClip System n=284 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Fluoroscopy Duration	33.9 minutes Standard Deviation 23.2	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: echocardiogram data was available for 302 subjects in the device arm and 311 subjects in the control arm.

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=311 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
MR Severity Grade MR 3+	148 Participants	172 Participants
MR Severity Grade MR 4+	154 Participants	139 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: Echocardiogram data was available for 286 subjects in the device arm and 257 subjects in the control arm.

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Outcome measures

Measure	MitraClip System n=286 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=257 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
MR Severity Grade MR None or 1+	230 Participants	21 Participants
MR Severity Grade MR 2+	39 Participants	67 Participants
MR Severity Grade MR 3+	13 Participants	96 Participants
MR Severity Grade MR 4+	4 Participants	73 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Echocardiogram data was available for only 240 subjects in the device group and 218 subjects in the control group

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Outcome measures

Measure	MitraClip System n=240 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=218 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
MR Severity Grade MR none or 1+	160 Participants	20 Participants
MR Severity Grade MR 2+	65 Participants	63 Participants
MR Severity Grade MR 3+	11 Participants	92 Participants
MR Severity Grade MR 4+	4 Participants	43 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Echocardiogram data was available for 210 subjects in the device arm and 175 subjects in the control arm.

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Outcome measures

Measure	MitraClip System n=210 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=175 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
MR Severity Grade MR None or 1+	145 Participants	20 Participants
MR Severity Grade MR 2+	54 Participants	62 Participants
MR Severity Grade MR 3+	9 Participants	60 Participants
MR Severity Grade MR 4+	2 Participants	33 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Echocardiogram data was available for 167 subjects in the device arm and 126 subjects in the control arm.

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Outcome measures

Measure	MitraClip System n=167 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=126 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
MR Severity Grade MR None or 1+	131 Participants	23 Participants
MR Severity Grade MR 2+	35 Participants	36 Participants
MR Severity Grade MR 3+	0 Participants	43 Participants
MR Severity Grade MR 4+	1 Participants	24 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Echocardiogram data was available for 120 subjects in the device arm and 74 subjects in the control arm.

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Outcome measures

Measure	MitraClip System n=120 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=74 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
MR Severity Grade MR None or 1+	100 Participants	48 Participants
MR Severity Grade MR 2+	18 Participants	15 Participants
MR Severity Grade MR 3+	2 Participants	8 Participants
MR Severity Grade MR 4+	0 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: Echocardiogram data was available for 80 subjects in the device arm and 49 subjects in the control arm.

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ -Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Outcome measures

Measure	MitraClip System n=80 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=49 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
MR Severity Grade MR None or 1+	64 Participants	30 Participants
MR Severity Grade MR 2+	14 Participants	9 Participants
MR Severity Grade MR 3+	2 Participants	6 Participants
MR Severity Grade MR 4+	0 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Echocardiogram data was available for 57 subjects in the device arm and 46 subjects in the control arm.

MR Severity Grading was done by Quantitative Doppler Echocardiography andsubjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effectiveregurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Rightventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ -Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitantorifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricularEF >=50%, Effective regurgitant orifice area >=40 mm^2

Outcome measures

Measure	MitraClip System n=57 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=46 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
MR Severity Grade MR None or 1+	51 Participants	36 Participants
MR Severity Grade MR 2+	3 Participants	6 Participants
MR Severity Grade MR 3+	3 Participants	2 Participants
MR Severity Grade MR 4+	0 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Echocardiogram data was available for the 289 subjects in the device arm and 302 subjects in the control arm.

Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity

Outcome measures

Measure	MitraClip System n=289 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=302 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Effective Regurgitant Orifice Area	0.41 cm^2 Standard Deviation 0.15	0.40 cm^2 Standard Deviation 0.15

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: Echocardiogram data was available for 75 subjects in the device arm and 73 subjects in the control arm.

Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity

Outcome measures

Measure	MitraClip System n=75 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=73 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Effective Regurgitant Orifice Area	0.14 cm^2 Standard Deviation 0.08	0.23 cm^2 Standard Deviation 0.16

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Echocardiogram data was available for 39 subjects in the device arm and 54 subjects in the control arm

Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity

Outcome measures

Measure	MitraClip System n=39 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=54 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Effective Regurgitant Orifice Area	0.22 cm^2 Standard Deviation 0.19	0.25 cm^2 Standard Deviation 0.14

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Echocardiogram data was available for 39 subjects in the device arm and 46 subjects in the control arm

Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity

Outcome measures

Measure	MitraClip System n=39 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=46 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Effective Regurgitant Orifice Area	0.18 cm^2 Standard Deviation 0.12	0.26 cm^2 Standard Deviation 0.19

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Echocardiogram data was available for 18 subjects in the device arm and 25 subjects in the control arm

Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity

Outcome measures

Measure	MitraClip System n=18 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=25 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Effective Regurgitant Orifice Area	0.15 cm^2 Standard Deviation 0.09	0.25 cm^2 Standard Deviation 0.12

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Echocardiogram data was available for 16 subjects in the device arm and 13 subjects in the control arm

Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity

Outcome measures

Measure	MitraClip System n=16 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=13 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Effective Regurgitant Orifice Area	0.18 cm^2 Standard Deviation 0.20	0.18 cm^2 Standard Deviation 0.10

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: Echocardiogram data was available for the 8 subjects in the device arm and 6 subjects in the control arm.

Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity

Outcome measures

Measure	MitraClip System n=8 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=6 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Effective Regurgitant Orifice Area	0.14 cm^2 Standard Deviation 0.05	0.19 cm^2 Standard Deviation 0.12

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Echocardiogram data was available for the 7 subjects in the device arm and 7 subjects in the control arm.

Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity

Outcome measures

Measure	MitraClip System n=7 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=7 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Effective Regurgitant Orifice Area	0.15 cm^2 Standard Deviation 0.05	0.15 cm^2 Standard Deviation 0.05

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Echocardiogram data was available for 124 subjects in the device arm and 136 subjects in the control arm.

Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.

Outcome measures

Measure	MitraClip System n=124 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=136 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Volume	28.80 ml/beat Standard Deviation 16.99	25.01 ml/beat Standard Deviation 15.31

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: Echocardiogram data was available for 85 subjects in device arm and 70 subjects in control arm

Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.

Outcome measures

Measure	MitraClip System n=85 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=70 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Volume	20.04 ml/beat Standard Deviation 11.86	25.97 ml/beat Standard Deviation 15.68

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Echocardiogram data was available for 45 subjects in the device arm and 54 subjects in the control arm.

Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.

Outcome measures

Measure	MitraClip System n=45 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=54 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Volume	23.60 ml/beat Standard Deviation 16.00	32.59 ml/beat Standard Deviation 15.82

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Echocardiogram data was available for 33 subjects in the device arm and 45 subjects in the control arm.

Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.

Outcome measures

Measure	MitraClip System n=33 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=45 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Volume	21.61 ml/beat Standard Deviation 12.12	27.76 ml/beat Standard Deviation 14.35

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Echocardiogram data was available for 21 subjects in the device arm and 28 subjects in the control arm

Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.

Outcome measures

Measure	MitraClip System n=21 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=28 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Volume	21.48 ml/beat Standard Deviation 11.34	32.96 ml/beat Standard Deviation 16.04

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Echocardiogram data was available for 20 subjects in the device arm and 17 subjects in the control arm

Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from theLeft Ventricular Outflow Tract (LVOT) stroke volume during systole.

Outcome measures

Measure	MitraClip System n=20 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=17 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Volume	18.80 ml/beat Standard Deviation 9.61	24.65 ml/beat Standard Deviation 12.26

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: Echocardiogram data was available for 11 subjects in the device arm and 5 subjects in the control arm.

Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.

Outcome measures

Measure	MitraClip System n=11 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=5 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Volume	18.36 ml/beat Standard Deviation 6.27	23.00 ml/beat Standard Deviation 14.47

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Echocardiogram data was available for 9 subjects in the device arm and 9 subjects in the control arm.

Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.

Outcome measures

Measure	MitraClip System n=9 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=9 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Volume	21.11 ml/beat Standard Deviation 10.11	18.78 ml/beat Standard Deviation 5.95

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Echocardiogram data was available for 123 subjects in the device group and 136 subjects in the control group.

Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.

Outcome measures

Measure	MitraClip System n=123 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=136 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Fraction	38.24 percentage Standard Deviation 13.81	34.81 percentage Standard Deviation 14.94

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: Echocardiogram data was available for 85 subjects in the device arm and 70 subjects in the control arm.

Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.

Outcome measures

Measure	MitraClip System n=85 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=70 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Fraction	31.00 percentage Standard Deviation 14.53	35.29 percentage Standard Deviation 15.32

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Echocardiogram data was available for 45 subjects in the device arm and 54 subjects in the control arm

Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.

Outcome measures

Measure	MitraClip System n=45 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=54 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Fraction	34.14 percentage Standard Deviation 15.89	42.20 percentage Standard Deviation 14.49

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Echocardiogram data was available for 33 subjects in the device arm and 45 subjects in the control arm.

Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.

Outcome measures

Measure	MitraClip System n=33 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=45 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Fraction	32.15 percentage Standard Deviation 13.06	37.80 percentage Standard Deviation 15.49

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Echocardiogram data is available for 21 subjects in the device arm and 28 subjects in the control arm.

Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.

Outcome measures

Measure	MitraClip System n=21 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=28 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Fraction	34.29 percentage Standard Deviation 14.52	41.79 percentage Standard Deviation 14.93

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: Echocardiogram data is available for 20 subjects in the device arm and 17 subjects in the control arm.

Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricledue to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.

Outcome measures

Measure	MitraClip System n=20 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=17 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Fraction	31.00 percentage Standard Deviation 12.38	38.71 percentage Standard Deviation 10.21

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: Echocardiogram data was available for 11 subjects in the device arm and 5 subjects in the control arm

Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.

Outcome measures

Measure	MitraClip System n=11 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=5 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Fraction	32.00 percentage Standard Deviation 7.72	38.80 percentage Standard Deviation 21.51

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: Echocardiogram data is available for 9 subjects in the device arm and 9 subjects in the control arm.

Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency

Outcome measures

Measure	MitraClip System n=9 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=9 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Regurgitant Fraction	37.78 percentage Standard Deviation 12.77	32.78 percentage Standard Deviation 9.20

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available echocardiogram data used for analysis.

Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.

Outcome measures

Measure	MitraClip System n=281 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=294 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricle End Diastolic Volume (LVEDV)	194.4 mL Standard Deviation 69.2	191.0 mL Standard Deviation 72.9

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: All available echocardiogram data has been presented.

Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.

Outcome measures

Measure	MitraClip System n=259 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=223 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricle End Diastolic Volume (LVEDV)	176.0 mL Standard Deviation 64.6	179.1 mL Standard Deviation 68.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available echocardiogram data has been presented.

Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.

Outcome measures

Measure	MitraClip System n=200 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=171 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricle End Diastolic Volume (LVEDV)	181.4 mL Standard Deviation 65.1	182.6 mL Standard Deviation 72.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available echocardiogram data has been presented.

Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.

Outcome measures

Measure	MitraClip System n=168 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=146 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricle End Diastolic Volume (LVEDV)	179.4 mL Standard Deviation 66.2	176.3 mL Standard Deviation 65.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available echocardiogram data has been presented

Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.

Outcome measures

Measure	MitraClip System n=121 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=94 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricle End Diastolic Volume (LVEDV)	174.5 mL Standard Deviation 60.9	184.6 mL Standard Deviation 73.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: All available echocardiogram data has been presented

Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.

Outcome measures

Measure	MitraClip System n=92 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=51 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricle End Diastolic Volume (LVEDV)	169.6 mL Standard Deviation 60.5	172.2 mL Standard Deviation 67.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: All available electrocardiogram data has been reported.

Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.

Outcome measures

Measure	MitraClip System n=53 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=33 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricle End Diastolic Volume (LVEDV)	166.0 mL Standard Deviation 58.4	161.6 mL Standard Deviation 64.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: All available echocardiogram data has been presented.

Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.

Outcome measures

Measure	MitraClip System n=37 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=32 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricle End Diastolic Volume (LVEDV)	174.0 ml Standard Deviation 67.1	166.6 ml Standard Deviation 77.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available echocardiogram data has been presented.

Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.

Outcome measures

Measure	MitraClip System n=281 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=294 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Volume (LVESV)	135.5 mL Standard Deviation 56.1	134.3 mL Standard Deviation 60.3

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: All available echocardiogram data has been presented.

Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.

Outcome measures

Measure	MitraClip System n=258 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=223 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Volume (LVESV)	129.3 mL Standard Deviation 56.5	125.7 mL Standard Deviation 57.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available echocardiogram data has been presented.

Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.

Outcome measures

Measure	MitraClip System n=200 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=171 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Volume (LVESV)	133.1 mL Standard Deviation 59.2	129.1 mL Standard Deviation 59.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available echocardiogram data has been presented.

Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.

Outcome measures

Measure	MitraClip System n=168 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=146 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Volume (LVESV)	133.0 mL Standard Deviation 60.9	125.9 mL Standard Deviation 54.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available echocardiogram data has been presented.

Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.

Outcome measures

Measure	MitraClip System n=121 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=94 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Volume (LVESV)	127.4 mL Standard Deviation 52.6	132.2 mL Standard Deviation 64.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: All available echocardiogram data has been reported.

Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction,or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at anypoint in the cardiac cycle.

Outcome measures

Measure	MitraClip System n=92 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=51 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Volume (LVESV)	124.3 mL Standard Deviation 58.3	122.9 mL Standard Deviation 61.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: All available electrocardiogram has been presented.

Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.

Outcome measures

Measure	MitraClip System n=53 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=33 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Volume (LVESV)	118.7 ml Standard Deviation 53.1	112.7 ml Standard Deviation 59.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: All available electrocardiogram has been presented.

Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.

Outcome measures

Measure	MitraClip System n=37 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=32 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Volume (LVESV)	129.0 ml Standard Deviation 65.4	119.3 ml Standard Deviation 70.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available echocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=301 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=307 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Diastolic Dimension (LVEDD)	6.17 cm Standard Deviation 0.73	6.19 cm Standard Deviation 0.75

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: All available echocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=286 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=249 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Diastolic Dimension (LVEDD)	6.10 cm Standard Deviation 0.75	7.41 cm Standard Deviation 19.58

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available echocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=231 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=210 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Diastolic Dimension (LVEDD)	6.12 cm Standard Deviation 0.77	6.15 cm Standard Deviation 0.81

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available echocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=198 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=174 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Diastolic Dimension (LVEDD)	6.08 cm Standard Deviation 0.77	6.10 cm Standard Deviation 0.83

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available echocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=157 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=126 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Diastolic Dimension (LVEDD)	6.07 cm Standard Deviation 0.92	6.18 cm Standard Deviation 0.88

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: All Available echocardiogram data has been entered

Outcome measures

Measure	MitraClip System n=115 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=77 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Diastolic Dimension (LVEDD)	6.12 cm Standard Deviation 0.78	6.11 cm Standard Deviation 0.97

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: All available echocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=78 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=49 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Diastolic Dimension (LVEDD)	6.04 cm Standard Deviation 0.81	6.07 cm Standard Deviation 0.91

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: All available echocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=57 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=45 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Diastolic Dimension (LVEDD)	6.09 cm Standard Deviation 0.90	5.97 cm Standard Deviation 0.91

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=301 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=306 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Dimension (LVESD)	5.28 cm Standard Deviation 0.86	5.30 cm Standard Deviation 0.89

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=286 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=248 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Dimension (LVESD)	5.31 cm Standard Deviation 0.89	6.12 cm Standard Deviation 12.64

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=231 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=208 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Dimension (LVESD)	5.34 cm Standard Deviation 0.91	5.28 cm Standard Deviation 0.96

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=197 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=173 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Dimension (LVESD)	5.26 cm Standard Deviation 0.95	5.25 cm Standard Deviation 0.99

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=156 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=123 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Dimension (LVESD)	5.24 cm Standard Deviation 1.07	5.26 cm Standard Deviation 1.02

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=112 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=75 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Dimension (LVESD)	5.30 cm Standard Deviation 0.96	5.19 cm Standard Deviation 1.16

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: All available electrocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=74 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=47 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Dimension (LVESD)	5.17 cm Standard Deviation 0.95	5.01 cm Standard Deviation 1.12

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: All available electrocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=54 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=42 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular End Systolic Dimension (LVESD)	5.31 cm Standard Deviation 1.02	5.15 cm Standard Deviation 1.02

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=281 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=294 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular Ejection Fraction (LVEF)	31.32 percentage Standard Deviation 9.07	31.30 percentage Standard Deviation 9.58

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=259 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=223 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular Ejection Fraction (LVEF)	27.88 percentage Standard Deviation 8.84	31.11 percentage Standard Deviation 10.45

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=200 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=171 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular Ejection Fraction (LVEF)	28.38 percentage Standard Deviation 10.45	30.44 percentage Standard Deviation 10.15

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=168 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=146 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular Ejection Fraction (LVEF)	27.74 percentage Standard Deviation 11.31	29.72 percentage Standard Deviation 10.06

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=121 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=94 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular Ejection Fraction (LVEF)	27.95 percentage Standard Deviation 9.2	30.68 percentage Standard Deviation 12.38

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=92 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=51 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular Ejection Fraction (LVEF)	29.28 percentage Standard Deviation 12.41	31.67 percentage Standard Deviation 12.76

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: All available electrocardiogram has been presented.

Outcome measures

Measure	MitraClip System n=53 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=33 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular Ejection Fraction (LVEF)	30.87 percentage Standard Deviation 11.37	33.39 percentage Standard Deviation 13.09

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: All electrocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=37 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=32 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Left Ventricular Ejection Fraction (LVEF)	28.73 percentage Standard Deviation 11.26	32.22 percentage Standard Deviation 13.95

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=253 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=275 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Right Ventricular Systolic Pressure (RVSP)	43.95 mmHg Standard Deviation 13.44	44.56 mmHg Standard Deviation 13.96

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=257 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=239 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Right Ventricular Systolic Pressure (RVSP)	41.41 mmHg Standard Deviation 11.63	43.81 mmHg Standard Deviation 14.24

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=196 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=188 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Right Ventricular Systolic Pressure (RVSP)	40.96 mmHg Standard Deviation 13.06	42.21 mmHg Standard Deviation 14.19

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=170 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=144 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Right Ventricular Systolic Pressure (RVSP)	38.63 mmHg Standard Deviation 13.00	39.31 mmHg Standard Deviation 13.24

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=128 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=100 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Right Ventricular Systolic Pressure (RVSP)	39.46 mmHg Standard Deviation 12.90	40.27 mmHg Standard Deviation 14.92

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=100 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=60 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Right Ventricular Systolic Pressure (RVSP)	37.73 mmHg Standard Deviation 11.56	37.57 mmHg Standard Deviation 13.61

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: All available electrocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=65 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=38 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Right Ventricular Systolic Pressure (RVSP)	37.37 mmHg Standard Deviation 13.04	39.76 mmHg Standard Deviation 14.54

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: All available electrocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=47 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=32 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Right Ventricular Systolic Pressure (RVSP)	34.85 mmHg Standard Deviation 12.92	35.41 mmHg Standard Deviation 12.12

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=284 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=302 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Valve Area	5.17 cm^2 Standard Deviation 1.26	5.16 cm^2 Standard Deviation 1.16

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=174 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=235 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Valve Area	2.68 cm^2 Standard Deviation 0.92	4.81 cm^2 Standard Deviation 1.00

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=107 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=189 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Valve Area	2.84 cm^2 Standard Deviation 1.10	4.94 cm^2 Standard Deviation 1.00

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=106 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=142 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Valve Area	2.67 cm^2 Standard Deviation 0.86	4.88 cm^2 Standard Deviation 0.95

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=65 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=94 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Valve Area	2.85 cm^2 Standard Deviation 1.01	4.98 cm^2 Standard Deviation 1.14

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=48 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=39 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Valve Area	3.06 cm^2 Standard Deviation 0.90	4.47 cm^2 Standard Deviation 1.58

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: All electrocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=21 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=25 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Valve Area	3.27 cm^2 Standard Deviation 0.79	4.39 cm^2 Standard Deviation 1.41

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: All available electrocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=11 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=20 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Valve Area	3.76 cm^2 Standard Deviation 1.11	4.33 cm^2 Standard Deviation 1.31

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available echocardiogram data has been reported.

The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.

Outcome measures

Measure	MitraClip System n=208 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=234 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mean Mitral Valve Gradient	2.46 mmHg Standard Deviation 1.05	2.28 mmHg Standard Deviation 0.97

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: All available echocardiogram data has been reported.

The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.

Outcome measures

Measure	MitraClip System n=282 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=184 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mean Mitral Valve Gradient	4.10 mmHg Standard Deviation 2.18	2.28 mmHg Standard Deviation 1.28

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available echocardiogram data has been reported.

The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.

Outcome measures

Measure	MitraClip System n=222 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=160 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mean Mitral Valve Gradient	4.00 mmHg Standard Deviation 1.98	2.28 mmHg Standard Deviation 1.28

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available echocardiogram data has been reported.

The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.

Outcome measures

Measure	MitraClip System n=197 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=138 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mean Mitral Valve Gradient	3.88 mmHg Standard Deviation 2.17	2.15 mmHg Standard Deviation 1.30

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available echocardiogram data has been reported.

The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.

Outcome measures

Measure	MitraClip System n=151 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=96 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mean Mitral Valve Gradient	3.69 mmHg Standard Deviation 1.76	2.25 mmHg Standard Deviation 1.71

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: All available echocardiogram data has been reported.

The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, thevalve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valvegradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.

Outcome measures

Measure	MitraClip System n=111 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=63 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mean Mitral Valve Gradient	3.45 mmHg Standard Deviation 1.80	2.62 mmHg Standard Deviation 1.99

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: All available electrocardiogram data has been presented.

The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.

Outcome measures

Measure	MitraClip System n=74 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=48 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mean Mitral Valve Gradient	3.69 mmHg Standard Deviation 1.85	2.56 mmHg Standard Deviation 1.41

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: All available electrocardiogram data has been presented.

The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.

Outcome measures

Measure	MitraClip System n=52 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=37 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mean Mitral Valve Gradient	4.07 mmHg Standard Deviation 2.31	3.54 mmHg Standard Deviation 4.27

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=300 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=310 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Present	1 Participants	1 Participants
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Absent	299 Participants	309 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=289 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=258 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Present	1 Participants	1 Participants
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Absent	288 Participants	257 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=239 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=219 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Present	0 Participants	1 Participants
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Absent	239 Participants	218 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available echocardiogram has been reported.

Outcome measures

Measure	MitraClip System n=210 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=177 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Present	0 Participants	0 Participants
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Absent	210 Participants	177 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available echocardiogram data has been reported.

Outcome measures

Measure	MitraClip System n=164 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=126 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Present	0 Participants	0 Participants
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Absent	164 Participants	126 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: All available data has been reported.

Outcome measures

Measure	MitraClip System n=120 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=78 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Present	0 Participants	0 Participants
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Absent	120 Participants	78 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: All electrocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=81 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=50 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Present	0 Participants	0 Participants
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Absent	81 Participants	50 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: All available electrocardiogram data has been presented.

Outcome measures

Measure	MitraClip System n=58 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=46 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Present	0 Participants	0 Participants
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Absent	58 Participants	46 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available echocardiogram data has been reported.

The amount of blood the heart pumps through the circulatory system in a minute.

Outcome measures

Measure	MitraClip System n=238 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=251 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Cardiac Output	3.61 Liters/minute Standard Deviation 1.09	3.49 Liters/minute Standard Deviation 1.08

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: All available echocardiogram data has been reported.

The amount of blood the heart pumps through the circulatory system in a minute.

Outcome measures

Measure	MitraClip System n=275 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=236 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Cardiac Output	3.79 Liters/minute Standard Deviation 1.17	3.61 Liters/minute Standard Deviation 1.18

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available echocardiogram has been reported.

The amount of blood the heart pumps through the circulatory system in a minute.

Outcome measures

Measure	MitraClip System n=217 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=199 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Cardiac Output	3.53 Liters/minute Standard Deviation 1.06	3.53 Liters/minute Standard Deviation 1.16

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available echocardiogram data has been reported.

The amount of blood the heart pumps through the circulatory system in a minute.

Outcome measures

Measure	MitraClip System n=196 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=157 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Cardiac Output	3.59 Liters/minute Standard Deviation 1.07	3.66 Liters/minute Standard Deviation 1.20

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available echocardiogram data has been reported.

The amount of blood the heart pumps through the circulatory system in a minute.

Outcome measures

Measure	MitraClip System n=144 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=116 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Cardiac Output	3.41 Liters/minute Standard Deviation 0.96	3.38 Liters/minute Standard Deviation 1.01

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: All available data has been entered.

The amount of blood the heart pumps through the circulatory system in a minute.

Outcome measures

Measure	MitraClip System n=110 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=68 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Cardiac Output	3.39 L/min Standard Deviation 1.01	3.36 L/min Standard Deviation 1.08

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: All available electrocardiogram data has been presented.

The amount of blood the heart pumps through the circulatory system in a minute.

Outcome measures

Measure	MitraClip System n=70 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=46 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Cardiac Output	3.49 liters/minute Standard Deviation 0.99	3.42 liters/minute Standard Deviation 1.27

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: All available electrocardiogram data has been presented.

The amount of blood the heart pumps through the circulatory system in a minute.

Outcome measures

Measure	MitraClip System n=47 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=38 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Cardiac Output	3.43 liters/minute Standard Deviation 1.02	3.41 liters/minute Standard Deviation 1.10

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available echocardiogram data has been reported.

Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.

Outcome measures

Measure	MitraClip System n=283 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=292 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Forward Stroke Volume	50.47 mL Standard Deviation 16.52	50.72 mL Standard Deviation 16.91

OTHER_PRE_SPECIFIED outcome

Timeframe: At discharge (or 30 days if discharge echocardiogram is not available)

Population: All available echocardiogram data has been reported.

Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.

Outcome measures

Measure	MitraClip System n=278 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=243 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Forward Stroke Volume	52.41 mL Standard Deviation 17.06	50.75 mL Standard Deviation 17.69

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available echocardiogram data has been reported.

Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.

Outcome measures

Measure	MitraClip System n=222 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=207 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Forward Stroke Volume	52.13 mL Standard Deviation 16.60	49.89 mL Standard Deviation 16.80

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available echocardiogram data has been reported.

Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.

Outcome measures

Measure	MitraClip System n=200 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=165 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Forward Stroke Volume	52.33 mL Standard Deviation 16.46	53.49 mL Standard Deviation 17.73

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available echocardiogram data has been reported.

Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.

Outcome measures

Measure	MitraClip System n=147 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=118 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Forward Stroke Volume	50.23 mL Standard Deviation 16.02	49.22 mL Standard Deviation 15.70

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: All available data has been reported.

Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.

Outcome measures

Measure	MitraClip System n=111 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=68 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Forward Stroke Volume	49.19 mL Standard Deviation 15.83	49.42 mL Standard Deviation 15.29

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: All available electrocardiogram data has been presented.

Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.

Outcome measures

Measure	MitraClip System n=70 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=48 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Forward Stroke Volume	50.95 mL Standard Deviation 16.46	48.32 mL Standard Deviation 14.36

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: All available electrocardiogram data has been presented.

Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.

Outcome measures

Measure	MitraClip System n=47 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=38 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Forward Stroke Volume	49.70 mL Standard Deviation 18.41	47.63 mL Standard Deviation 16.75

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months in Device group

Population: All eligible subjects with MitraClip until the 365 day window.

Freedom from the components of the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.

Outcome measures

Measure	MitraClip System n=237 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Single Leaflet Device Attachment (SLDA)	99.3 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Embolization	99.7 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Left Ventricular Assist Device (LVAD)	98.8 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Heart Transplant	99.2 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Non-elective Cardiovascular surgery	99.7 percentage	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months in Device group

Population: All available subjects with data within the 2 year (731 days) window

Freedom from the components of the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.

Outcome measures

Measure	MitraClip System n=204 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Single Leaflet Device Attachment (SLDA)	99.3 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Embolization	99.7 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Left Ventricular Assist Device (LVAD)	97.4 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Heart Transplant	98.7 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Non-elective cardiovascular surgery	99.7 percentage	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years in Device group

Population: All available subjects within the 36 month (1096 days) window.

Freedom from the components of the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.

Outcome measures

Measure	MitraClip System n=164 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Single Leaflet DeviceAttachment (SLDA)	99.3 Percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Embolization	99.7 Percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Left Ventricular AssistDevice (LVAD)	94.9 Percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Heart Transplant	96.6 Percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Non-electivecardiovascular surgery	99.7 Percentage	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years in Device group

Population: All subjects within the 4 year (1461 days) window.

Freedom from the components of the primary safety composite of device relatedcomplications including Single Leaflet Device Attachment (SLDA), deviceembolizations, endocarditis requiring surgery, Echocardiography Core Laboratoryconfirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at12 months will be the primary measure of safety.

Outcome measures

Measure	MitraClip System n=138 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Single Leaflet Device Attachment (SLDA)	99.3 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Embolization	99.7 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Left Ventricular Assist Device (LVAD)	94.2 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Heart Transplant	95.3 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Non-elective Cardiovascular Surgery	99.7 percentage	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years in Device group

Population: All available subjects within 5 year (1826 days) window.

Freedom from the components of the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at12 months will be the primary measure of safety.

Outcome measures

Measure	MitraClip System n=70 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Single LeafletDeviceAttachment(SLDA)	99.3 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Embolization	99.7 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Left VentricularAssistDevice (LVAD)	93.5 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Heart Transplant	95.3 percentage	—
Kaplan-Meier Freedom From the Components of the Primary Safety Composite Non-electivecardiovascularsurgery	99.7 percentage	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months in Device group

Population: All available subjects with data within the 24 months (731 days) window.

Freedom from the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.

Outcome measures

Measure	MitraClip System n=197 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the Primary Safety Composite	94.8 percentage	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years in Device group

Population: All available subjects with data within the 36 months (1096 days) window.

Freedom from the primary safety composite of device related complications including Single Leaflet DeviceAttachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratoryconfirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complicationsrequiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.

Outcome measures

Measure	MitraClip System n=154 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the Primary Safety Composite	91.2 Percentage	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years in Device group

Population: All available echocardiogram data has been presented.

Freedom from the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.

Outcome measures

Measure	MitraClip System n=128 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the Primary Safety Composite	89.9 percentage	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years in Device group

Population: All available electrocardiogram has been presented.

Freedom from the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.

Outcome measures

Measure	MitraClip System n=62 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the Primary Safety Composite	89.2 percentage	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Kaplan-Meier survival rate for all cause mortality at 24 months

Outcome measures

Measure	MitraClip System n=205 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=157 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From All-cause Mortality	71.9 percentage Interval 66.4 to 76.6	57.3 percentage Interval 51.4 to 62.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Kaplan-Meier survival rate for all cause mortality at 36 months

Outcome measures

Measure	MitraClip System n=167 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=122 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From All-cause Mortality	59.7 Percentage Interval 53.8 to 65.1	45.9 Percentage Interval 40.0 to 51.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Kaplan-Meier survival rate for all cause mortality at 48 months

Outcome measures

Measure	MitraClip System n=138 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=94 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From All-cause Mortality	51.3 percentage Interval 45.4 to 57.0	37.3 percentage Interval 31.6 to 43.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Kaplan-Meier survival rate for all cause mortality at 60 months

Outcome measures

Measure	MitraClip System n=79 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=59 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From All-cause Mortality	42.7 percentage Interval 36.8 to 48.5	32.8 percentage Interval 27.2 to 38.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Kaplan-Meier survival rate for Cardiovascular mortality.

Outcome measures

Measure	MitraClip System n=238 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=223 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From Cardiovascular Mortality	86.2 percentage Interval 81.6 to 89.7	80.7 percentage Interval 75.7 to 84.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Kaplan-Meier survival rate for Cardiovascular mortality.

Outcome measures

Measure	MitraClip System n=205 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=156 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From Cardiovascular Mortality	77.6 percentage Interval 72.3 to 82.1	64.5 percentage Interval 58.6 to 69.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Kaplan-Meier survival rate for Cardiovascular mortality.

Outcome measures

Measure	MitraClip System n=167 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=120 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From Cardiovascular Mortality	66.7 Percentage Interval 60.7 to 72.0	54.6 Percentage Interval 48.3 to 60.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Outcome measures

Measure	MitraClip System n=138 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=94 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From Cardiovascular Mortality	58.8 percentage Interval 52.6 to 64.5	47.0 percentage Interval 40.6 to 53.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Outcome measures

Measure	MitraClip System n=79 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=59 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From Cardiovascular Mortality	51.2 percentage Interval 44.8 to 57.2	42.8 percentage Interval 36.4 to 49.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Outcome measures

Measure	MitraClip System n=194 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=157 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First HF Related Hospitalization	74.4 Percentage Interval 68.9 to 79.1	60.4 Percentage Interval 54.5 to 65.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Outcome measures

Measure	MitraClip System n=158 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=95 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First HF Related Hospitalization	64.5 Percentage Interval 58.5 to 69.9	43.9 Percentage Interval 37.9 to 49.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Outcome measures

Measure	MitraClip System n=118 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=43 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First HF Related Hospitalization	53.2 Percentage Interval 46.9 to 59.2	23.6 Percentage Interval 18.2 to 29.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Outcome measures

Measure	MitraClip System n=93 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=33 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First HF Related Hospitalization	45.7 percentage Interval 39.3 to 51.8	22.3 percentage Interval 17.0 to 28.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Outcome measures

Measure	MitraClip System n=52 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=17 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First HF Related Hospitalization	39.0 percentage Interval 32.6 to 45.4	17.0 percentage Interval 11.9 to 22.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Outcome measures

Measure	MitraClip System n=166 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=137 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First Cardiovascular Hospitalization	61.7 Percentage Interval 55.8 to 67.1	51.3 Percentage Interval 45.5 to 56.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Outcome measures

Measure	MitraClip System n=126 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=78 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First Cardiovascular Hospitalization	49.5 Percentage Interval 43.5 to 55.2	33.5 Percentage Interval 27.9 to 39.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Outcome measures

Measure	MitraClip System n=87 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=36 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First Cardiovascular Hospitalization	37.3 Percentage Interval 31.4 to 43.1	17.5 Percentage Interval 12.9 to 22.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Outcome measures

Measure	MitraClip System n=63 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=26 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First Cardiovascular Hospitalization	28.5 Percentage Interval 23.0 to 34.2	14.8 Percentage Interval 10.5 to 19.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Outcome measures

Measure	MitraClip System n=34 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=11 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First Cardiovascular Hospitalization	23.0 Percentage Interval 17.9 to 28.6	10.8 Percentage Interval 7.0 to 15.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Outcome measures

Measure	MitraClip System n=196 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=156 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality	66.5 Percentage Interval 60.8 to 71.5	53.8 Percentage Interval 48.1 to 59.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available data has been reported.

Survival rate from the first HF related hospitalization or all-cause mortality.

Outcome measures

Measure	MitraClip System n=158 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=95 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality	54.8 percentage Interval 48.9 to 60.3	33.8 percentage Interval 28.4 to 39.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Outcome measures

Measure	MitraClip System n=118 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=43 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality	41.5 Percentage Interval 35.8 to 47.1	15.5 Percentage Interval 11.5 to 20.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Outcome measures

Measure	MitraClip System n=93 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=33 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality	34.0 percentage Interval 28.6 to 39.5	12.8 percentage Interval 9.1 to 17.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Outcome measures

Measure	MitraClip System n=52 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=17 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality	26.4 percentage Interval 21.4 to 31.7	8.5 percentage Interval 5.5 to 12.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: NYHA Class data available for only 311 subjects

Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
NYHA Functional Class NYHA Class III	154 Participants	168 Participants
NYHA Functional Class NYHA Class IV	18 Participants	33 Participants
NYHA Functional Class NYHA Class I	1 Participants	0 Participants
NYHA Functional Class NYHA Class II	129 Participants	110 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: All available data at 30 day follow-up

Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations

Outcome measures

Measure	MitraClip System n=281 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=278 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
NYHA Functional Class NYHA Class I	44 Participants	14 Participants
NYHA Functional Class NYHA Class II	172 Participants	120 Participants
NYHA Functional Class NYHA Class III	55 Participants	117 Participants
NYHA Functional Class NYHA Class IV	10 Participants	27 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations

Outcome measures

Measure	MitraClip System n=253 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=238 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
NYHA Functional Class NYHA Class I	51 Participants	14 Participants
NYHA Functional Class NYHA Class II	139 Participants	117 Participants
NYHA Functional Class NYHA Class III	56 Participants	100 Participants
NYHA Functional Class NYHA Class IV	7 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations

Outcome measures

Measure	MitraClip System n=219 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=191 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
NYHA Functional Class NYHA Class I	40 Participants	18 Participants
NYHA Functional Class NYHA Class II	131 Participants	97 Participants
NYHA Functional Class NYHA Class III	42 Participants	65 Participants
NYHA Functional Class NYHA Class IV	6 Participants	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations

Outcome measures

Measure	MitraClip System n=176 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=143 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
NYHA Functional Class NYHA Class I	31 Participants	12 Participants
NYHA Functional Class NYHA Class II	91 Participants	69 Participants
NYHA Functional Class NYHA Class III	44 Participants	54 Participants
NYHA Functional Class NYHA Class IV	10 Participants	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifyingthe extent of heart failure. It classifies patients in one of four categories based on their limitations during physicalactivity:

Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness ofbreath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due tosymptoms Class IV: Severe limitations

Outcome measures

Measure	MitraClip System n=146 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=102 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
NYHA Functional Class NYHA Class I	25 Participants	16 Participants
NYHA Functional Class NYHA Class II	85 Participants	48 Participants
NYHA Functional Class NYHA Class III	32 Participants	32 Participants
NYHA Functional Class NYHA Class IV	4 Participants	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Outcome measures

Measure	MitraClip System n=125 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=76 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
NYHA Functional Class NYHA Class I	21 Participants	10 Participants
NYHA Functional Class NYHA Class IV	5 Participants	5 Participants
NYHA Functional Class NYHA Class II	70 Participants	36 Participants
NYHA Functional Class NYHA Class III	29 Participants	25 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Outcome measures

Measure	MitraClip System n=94 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=65 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
NYHA Functional Class NYHA Class I	17 Participants	12 Participants
NYHA Functional Class NYHA Class II	45 Participants	27 Participants
NYHA Functional Class NYHA Class III	28 Participants	26 Participants
NYHA Functional Class NYHA Class IV	4 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available 6MWD has been reported.

Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

Outcome measures

Measure	MitraClip System n=296 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=305 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Six-Minute Walk Test Distance (6MWD)	249.6 meters Standard Deviation 123.8	234.5 meters Standard Deviation 123.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

Outcome measures

Measure	MitraClip System n=265 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=244 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
6MWD	290.1 meters Standard Deviation 122.8	243.0 meters Standard Deviation 121.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available 6MWD has been reported

Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

Outcome measures

Measure	MitraClip System n=237 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=203 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
6MWD	288.6 meters Standard Deviation 128.0	253.9 meters Standard Deviation 126.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available 6MWD has been reported

Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

Outcome measures

Measure	MitraClip System n=193 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=167 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
6MWD	308.4 meters Standard Deviation 116.7	269.7 meters Standard Deviation 133.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available 6MWD has been reported.

Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

Outcome measures

Measure	MitraClip System n=143 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=111 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
6MWD	294.2 meters Standard Deviation 131.2	273.8 meters Standard Deviation 142.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 30 days

Population: All available data has been reported

Outcome measures

Measure	MitraClip System n=260 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=243 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in 6MWD From Baseline	31.6 meters Standard Deviation 106.4	-0.9 meters Standard Deviation 83.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 6 months

Population: All available data has been reported.

Outcome measures

Measure	MitraClip System n=233 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=201 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in 6MWD From Baseline	25.9 meters Standard Deviation 100.6	0.66 meters Standard Deviation 99.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 12 months

Population: All available data has been reported.

Outcome measures

Measure	MitraClip System n=191 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=166 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in 6MWD From Baseline	33.9 meters Standard Deviation 99.6	5.5 meters Standard Deviation 115.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 24 months

Population: All available data has been reported.

Outcome measures

Measure	MitraClip System n=142 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=110 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in 6MWD From Baseline	12.5 meters Standard Deviation 103.0	1.1 meters Standard Deviation 133.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available data has been reported.

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score.

Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification.

Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=309 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores	53.2 KCCQ score on a points scale Standard Deviation 22.8	51.6 KCCQ score on a points scale Standard Deviation 23.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: All available data has been reported.

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score.

Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification.

Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

Outcome measures

Measure	MitraClip System n=279 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=275 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
KCCQ QoL Scores	70.9 KCCQ score on a points scale Standard Deviation 21.1	54.6 KCCQ score on a points scale Standard Deviation 24.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available data has been reported.

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score.

Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification.

Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

Outcome measures

Measure	MitraClip System n=252 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=237 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
KCCQ QoL Scores	73.0 KCCQ score on a points scale Standard Deviation 21.3	59.0 KCCQ score on a points scale Standard Deviation 24.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available data has been reported.

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score.

Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification.

Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

Outcome measures

Measure	MitraClip System n=219 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=189 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
KCCQ QoL Scores	71.8 KCCQ score on a points scale Standard Deviation 22.2	60.2 KCCQ score on a points scale Standard Deviation 24.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available data has been reported.

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score.

Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification.

Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

Outcome measures

Measure	MitraClip System n=175 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=138 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
KCCQ QoL Scores	71.3 KCCQ score on a points scale Standard Deviation 23.3	58.9 KCCQ score on a points scale Standard Deviation 25.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 30 days

Population: All available paired data has been reported.

Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 30 days KCCQ score.

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score.

Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification.

Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

Outcome measures

Measure	MitraClip System n=279 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=272 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in KCCQ QoL Scores From Baseline	16.9 KCCQ score on a points scale Standard Deviation 22.8	2.1 KCCQ score on a points scale Standard Deviation 18.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 6 months

Population: All available paired data has been reported.

Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 6 months KCCQ score.

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score.

Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification.

Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

Outcome measures

Measure	MitraClip System n=252 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=236 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in KCCQ QoL Scores From Baseline	18.5 KCCQ score on a points scale Standard Deviation 24.9	5.3 KCCQ score on a points scale Standard Deviation 23.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 12 months

Population: All available paired data has been reported.

Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 12 months KCCQ score.

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score.

Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification.

Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

Outcome measures

Measure	MitraClip System n=219 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=188 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in KCCQ QoL Scores From Baseline	17.0 KCCQ score on a points scale Standard Deviation 25.4	5.1 KCCQ score on a points scale Standard Deviation 24.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 24 months

Population: All available paired data has been reported.

Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 24 months KCCQ score.

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score.

Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification.

Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

Outcome measures

Measure	MitraClip System n=175 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=138 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in KCCQ QoL Scores From Baseline	17.4 KCCQ score on a points scale Standard Deviation 25.8	3.4 KCCQ score on a points scale Standard Deviation 26.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available data has been reported.

The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

Outcome measures

Measure	MitraClip System n=299 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=308 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
SF-36 QoL Scores SF-36 PCS	33.0 SF-36 score on a points scale Standard Deviation 9.1	32.6 SF-36 score on a points scale Standard Deviation 10.0
SF-36 QoL Scores SF-36 MCS	46.7 SF-36 score on a points scale Standard Deviation 12.7	13.0 SF-36 score on a points scale Standard Deviation 12.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: All available data has been reported.

The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

Outcome measures

Measure	MitraClip System n=278 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=272 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
SF-36 QoL Scores SF-36 PCS	39.2 SF-36 score on a points scale Standard Deviation 9.2	33.6 SF-36 score on a points scale Standard Deviation 9.9
SF-36 QoL Scores SF-36 MCS	51.4 SF-36 score on a points scale Standard Deviation 11.5	46.1 SF-36 score on a points scale Standard Deviation 13.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available data has been reported.

The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

Outcome measures

Measure	MitraClip System n=251 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=237 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
SF-36 QoL Scores SF-36 PCS	39.0 SF-36 scores on a points scale Standard Deviation 10.3	34.2 SF-36 scores on a points scale Standard Deviation 9.9
SF-36 QoL Scores SF-36 MCS	52.1 SF-36 scores on a points scale Standard Deviation 10.3	47.0 SF-36 scores on a points scale Standard Deviation 12.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available data has been reported.

The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

Outcome measures

Measure	MitraClip System n=218 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=190 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
SF-36 QoL Scores SF-36 PCS	38.7 SF-36 scores on a points scale Standard Deviation 10.2	34.6 SF-36 scores on a points scale Standard Deviation 10.8
SF-36 QoL Scores SF-36 MCS	51.3 SF-36 scores on a points scale Standard Deviation 10.8	48.2 SF-36 scores on a points scale Standard Deviation 13.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available data has been reported.

The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

Outcome measures

Measure	MitraClip System n=174 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=137 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
SF-36 QoL Scores SF-36 PCS	38.7 SF-36 scores on a points scale Standard Deviation 10.4	33.7 SF-36 scores on a points scale Standard Deviation 9.8
SF-36 QoL Scores SF-36 MCS	50.6 SF-36 scores on a points scale Standard Deviation 12.1	47.2 SF-36 scores on a points scale Standard Deviation 12.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 30 days

Population: All available data has been reported.

Paired data looking at difference between the baseline SF-36 and 30 days SF-36. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

Outcome measures

Measure	MitraClip System n=276 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=269 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in SF-36 QoL Scores From Baseline SF-36 PCS	6.0 SF-36 score on a points scale Standard Deviation 8.9	0.6 SF-36 score on a points scale Standard Deviation 8.1
Change in SF-36 QoL Scores From Baseline SF_36 MCS	4.2 SF-36 score on a points scale Standard Deviation 12.2	0.4 SF-36 score on a points scale Standard Deviation 12.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 6 months

Population: All available data has been reported.

Paired data looking at difference between the baseline SF-36 and 6 months days SF-36.

The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

Outcome measures

Measure	MitraClip System n=248 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=234 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in SF-36 QoL Scores From Baseline SF-36 PCS	5.5 SF-36 score on a points scale Standard Deviation 10.2	1.0 SF-36 score on a points scale Standard Deviation 8.7
Change in SF-36 QoL Scores From Baseline SF-36 MCS	4.6 SF-36 score on a points scale Standard Deviation 12.2	1.1 SF-36 score on a points scale Standard Deviation 10.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 12 months

Population: All available data has been reported.

Paired data looking at difference between the baseline SF-36 and 12 month SF-36.

The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

Outcome measures

Measure	MitraClip System n=215 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=187 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in SF-36 QoL Scores From Baseline SF-36 PCS	5.0 SF-36 score on a points scale Standard Deviation 10.4	0.8 SF-36 score on a points scale Standard Deviation 9.8
Change in SF-36 QoL Scores From Baseline SF-36 MCS	4.3 SF-36 score on a points scale Standard Deviation 13.2	1.9 SF-36 score on a points scale Standard Deviation 13.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 24 months

Population: All available data has been reported.

Paired data looking at difference between the baseline SF-36 and 24 months SF-36.

The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

Outcome measures

Measure	MitraClip System n=171 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=136 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Change in SF-36 QoL Scores From Baseline SF-36 PCS	5.0 SF-36 score on a points scale Standard Deviation 10.4	0.7 SF-36 score on a points scale Standard Deviation 10.6
Change in SF-36 QoL Scores From Baseline SF-36 MCS	3.8 SF-36 score on a points scale Standard Deviation 14.2	-0.3 SF-36 score on a points scale Standard Deviation 12.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 5 years

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group Mitral Valve Surgery Elective - Repair	0 Participants	3 Participants
Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group Mitral Valve Surgery Elective - Replacement	1 Participants	5 Participants
Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group Mitral Valve Surgery Non Elective - Repair	0 Participants	0 Participants
Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group Mitral Valve Surgery Non Elective - Replacement	0 Participants	0 Participants
Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group New Use of CRT	8 Participants	11 Participants
Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group New use of single or dual chamber Pacemaker	10 Participants	10 Participants
Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group Permanent LVAD Implant	16 Participants	18 Participants
Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group Heart Transplant	9 Participants	11 Participants
Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group Additional MitraClip Device Intervention	10 Participants	NA Participants MitraClip Intervention is not applicable for Control Group

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 5 years

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
De Novo MitraClip Device Intervention in Control Group	NA Participants This is only applicable for Control Group	67 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Where responder is defined as alive and experiencing an improvement of 24 meters and 50 meters (difference in proportion of responders between Device and Control groups)

Outcome measures

Measure	MitraClip System n=191 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=166 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Responder Analysis for 6MWD Experiencing Improvement >= 24 meters	100 Participants	66 Participants
Responder Analysis for 6MWD Experiencing Improvement >= 50 meters	75 Participants	42 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Where responder is defined as alive and experiencing an improvement of 24 meters and 50 meters (difference in proportion of responders between Device and Control groups)

Outcome measures

Measure	MitraClip System n=106 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=72 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Responder Analysis for 6MWD Experiencing Improvement >= 24 meters	44 Participants	34 Participants
Responder Analysis for 6MWD Experiencing Improvement >= 50 meters	34 Participants	23 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available echocardiogram data has been reported.

Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)

Outcome measures

Measure	MitraClip System n=160 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=130 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Responder Analysis for LVEDV Index	35 Participants	32 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available echocardiogram data has been reported.

Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)

Outcome measures

Measure	MitraClip System n=115 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=89 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Responder Analysis for LVEDV Index	26 Participants	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: All available echocardiogram data has been reported.

Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)

Outcome measures

Measure	MitraClip System n=88 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=43 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Responder Analysis for LVEDV Index	20 Participants	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)

Outcome measures

Measure	MitraClip System n=53 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=28 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Responder Analysis for LVEDV Index	13 Participants	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)

Outcome measures

Measure	MitraClip System n=36 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=26 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Responder Analysis for LVEDV Index	9 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available data has been reported.

Where responder is defined as alive and experiencing an improvement of 5 points (difference in proportion of responders between Device and Control groups)

Outcome measures

Measure	MitraClip System n=219 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=188 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Responder Analysis for QoL (KCCQ)	151 Participants	103 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available data has been reported.

Where responder is defined as alive and experiencing an improvement of 5 points (difference in proportion of responders between Device and Control groups)

Outcome measures

Measure	MitraClip System n=128 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=90 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Responder Analysis for QoL (KCCQ)	88 Participants	46 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: 219 subjects from device group and 189 subjects from control group analyzed.

difference in means between Device and Control groups for the Kansas City Cardiomyopathy Questionnaire (KCCQ) for the physical limitation and symptom stability scores.

Outcome measures

Measure	MitraClip System n=408 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Each Subscale for QoL (KCCQ)	9.90 KCCQ score on a points scale Interval 5.51 to 14.29	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: 128 subjects in the device group and 90 subjects in the control group were analyzed.

difference in means between Device and Control groups for the Kansas City Cardiomyopathy Questionnaire (KCCQ) for the physical limitation and symptom stability scores.

Outcome measures

Measure	MitraClip System n=218 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Each Subscale for QoL (KCCQ)	8.01 KCCQ score on a points scale Interval 1.68 to 14.35	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Before MitraClip procedure on day 0

Population: Data was available for 293 subjects out of 302 subjects in the device group.

Length of stay in the hospital for the MitraClip Index procedure (device group)

Outcome measures

Measure	MitraClip System n=293 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Length of Index Hospitalization for MitraClip Procedure (Device Group)	2.5 Days Standard Deviation 2.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

in each of the Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) Heart Failure	70 Participants	118 Participants
Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) Cardiovascular	52 Participants	54 Participants
Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) Non-Cardiovascular	95 Participants	97 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

in each of the Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) Heart Failure	92 Participants	151 Participants
Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) Cardiovascular	72 Participants	72 Participants
Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) Non-Cardiovascular	124 Participants	128 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the time of randomization to 12 months

mean no of days alive and out of hospital in both Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Days Alive and Out of Hospital	316.6 Number of days Standard Deviation 93.9	305.4 Number of days Standard Deviation 98.6

OTHER_PRE_SPECIFIED outcome

Timeframe: From the time of randomization to 24 months

mean Number of days alive and out of hospital for the Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Days Alive and Out of Hospital	579.4 Number of Days Standard Deviation 234.0	521.1 Number of Days Standard Deviation 245

OTHER_PRE_SPECIFIED outcome

Timeframe: From the time of randomization to 3 Years

Mean Number of days alive and out of hospital for the Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Days Alive and Out of Hospital	799.0 Number of Days Standard Deviation 380.9	676.6 Number of Days Standard Deviation 389.9

OTHER_PRE_SPECIFIED outcome

Timeframe: From the time of randomization to 4 Years

difference in medians between Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Days Alive and Out of Hospital	979.3 Number of Days Standard Deviation 527.4	797.5 Number of Days Standard Deviation 527.4

OTHER_PRE_SPECIFIED outcome

Timeframe: From the time of randomization to 5 Years

difference in medians between Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Days Alive and Out of Hospital	1123.5 Number of Days Standard Deviation 664.8	894.8 Number of Days Standard Deviation 655.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

mean Number of days hospitalized from the "Treatment" visit for the Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Days Hospitalized From the "Treatment" Visit	9.2 Number of Days Standard Deviation 14.7	9.6 Number of Days Standard Deviation 16.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

mean Number of days hospitalized from the "Treatment" visit for the Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Days Hospitalized From the "Treatment" Visit	13.0 Number of Days Standard Deviation 20.0	13.9 Number of Days Standard Deviation 19.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Years

mean Number of days hospitalized from the "Treatment" visit for the Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Days Hospitalized From the "Treatment" Visit	18.4 Number of Days Standard Deviation 28.3	17.5 Number of Days Standard Deviation 22.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 Years

difference in medians between Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Days Hospitalized From the "Treatment" Visit	21.3 Number of Days Standard Deviation 31.1	19.0 Number of Days Standard Deviation 23.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 Years

difference in medians between Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Number of Days Hospitalized From the "Treatment" Visit	23.8 Number of Days Standard Deviation 33.7	19.8 Number of Days Standard Deviation 24.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

summarized and compared between Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Proportion of Alive Time in Hospital	0.05 Number of Days Standard Deviation 0.10	0.04 Number of Days Standard Deviation 0.09

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

summarized and compared between Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Proportion of Alive Time in Hospital	0.04 Number of Days Standard Deviation 0.10	0.04 Number of Days Standard Deviation 0.08

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

summarized and compared between Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=311 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Proportion of Alive Time in Hospital	0.05 Number of Days Standard Deviation 0.10	0.05 Number of Days Standard Deviation 0.08

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

summarized and compared between Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=311 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Proportion of Alive Time in Hospital	0.05 Number of Days Standard Deviation 0.10	0.05 Number of Days Standard Deviation 0.08

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

summarized and compared between Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=311 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Proportion of Alive Time in Hospital	0.05 Number of Days Standard Deviation 0.10	0.05 Number of Days Standard Deviation 0.08

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Subjects living in the baseline location include : home, retirement home, nursing facility and other location.

Outcome measures

Measure	MitraClip System n=223 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=206 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Proportion of Subjects Living in the Baseline Location	217 Participants	198 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Subjects living in the baseline location include : home, retirement home, nursing facility and other location.

Outcome measures

Measure	MitraClip System n=132 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=93 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Proportion of Subjects Living in the Baseline Location	130 Participants	87 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Outcome measures

Measure	MitraClip System n=154 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=113 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Proportion of Subjects Living in the Baseline Location	150 Participants	108 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Outcome measures

Measure	MitraClip System n=132 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=89 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Proportion of Subjects Living in the Baseline Location	129 Participants	86 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Outcome measures

Measure	MitraClip System n=107 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=78 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Proportion of Subjects Living in the Baseline Location	98 Participants	72 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Subjects with mitral valve replacements in the Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Valve Replacement Rates	1 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Subjects with mitral valve replacements in the Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Valve Replacement Rates	1 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

summarized and compared between Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Valve Replacement Rates	1 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

summarized and compared between Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Valve Replacement Rates	1 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

summarized and compared between Device and Control groups

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Valve Replacement Rates	1 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
New Onset of Permanent Atrial Fibrillation	14 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
New Onset of Permanent Atrial Fibrillation	18 Participants	15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
New Onset of Permanent Atrial Fibrillation	22 Participants	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
New Onset of Permanent Atrial Fibrillation	23 Participants	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
New Onset of Permanent Atrial Fibrillation	23 Participants	23 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Stenosis	18 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Stenosis	25 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Stenosis	22 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Stenosis	23 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Mitral Stenosis	23 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available data has been reported.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Brain Natriuretic Peptide (BNP) or N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels) BNP	1014.77 pg/ml Standard Deviation 1085.98	1017.13 pg/ml Standard Deviation 1212.77
Brain Natriuretic Peptide (BNP) or N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels) NT-proBNP	5174.33 pg/ml Standard Deviation 6566.61	5943.86 pg/ml Standard Deviation 8437.61

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: All available data has been reported.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
BNP or NT-proBNP Levels BNP	875.91 pg/ml Standard Deviation 931.18	1065.55 pg/ml Standard Deviation 1206.34
BNP or NT-proBNP Levels NT-proBNP	4907.58 pg/ml Standard Deviation 7483.72	5244.16 pg/ml Standard Deviation 7851.05

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available data has been reported.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
BNP or NT-proBNP Levels BNP	621.45 pg/ml Standard Deviation 606.99	808.26 pg/ml Standard Deviation 1711.71
BNP or NT-proBNP Levels NT-proBNP	3362.49 pg/ml Standard Deviation 4332.12	3977.80 pg/ml Standard Deviation 5689.70

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

MODIFIED RANKIN SCALE SCORE DESCRIPTIONS:

0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=308 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Modified Rankin Scale Score 0	170 Participants	158 Participants
Modified Rankin Scale Score 1	52 Participants	55 Participants
Modified Rankin Scale Score 2	55 Participants	58 Participants
Modified Rankin Scale Score 3	23 Participants	35 Participants
Modified Rankin Scale Score 4	2 Participants	2 Participants
Modified Rankin Scale Score 5	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

MODIFIED RANKIN SCALE SCORE DESCRIPTIONS:

0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

Outcome measures

Measure	MitraClip System n=278 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=276 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Modified Rankin Scale Score 0	169 Participants	129 Participants
Modified Rankin Scale Score 1	56 Participants	54 Participants
Modified Rankin Scale Score 2	40 Participants	49 Participants
Modified Rankin Scale Score 3	13 Participants	34 Participants
Modified Rankin Scale Score 4	0 Participants	8 Participants
Modified Rankin Scale Score 5	0 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

MODIFIED RANKIN SCALE SCORE DESCRIPTIONS:

0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

Outcome measures

Measure	MitraClip System n=250 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=234 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Modified Rankin Scale Score 0	145 Participants	120 Participants
Modified Rankin Scale Score 1	60 Participants	48 Participants
Modified Rankin Scale Score 2	30 Participants	38 Participants
Modified Rankin Scale Score 3	13 Participants	20 Participants
Modified Rankin Scale Score 4	2 Participants	8 Participants
Modified Rankin Scale Score 5	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

MODIFIED RANKIN SCALE SCORE DESCRIPTIONS:

0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

Outcome measures

Measure	MitraClip System n=219 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=189 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Modified Rankin Scale Score 0	134 Participants	100 Participants
Modified Rankin Scale Score 1	42 Participants	40 Participants
Modified Rankin Scale Score 2	34 Participants	27 Participants
Modified Rankin Scale Score 3	9 Participants	14 Participants
Modified Rankin Scale Score 4	0 Participants	7 Participants
Modified Rankin Scale Score 5	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Major Bleeding	15 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Defined as pulmonary insufficiency requiring ventilatory support for greater than 48 hours post-catheterization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Average Dosages of Guideline Directed Medical Therapy (GDMT) ACE Inhibitors	14.18 mg Standard Deviation 15.19	13.44 mg Standard Deviation 13.56
Average Dosages of Guideline Directed Medical Therapy (GDMT) Angiotensin-Receptor Blockers (ARB)	14.21 mg Standard Deviation 9.37	12.35 mg Standard Deviation 8.69
Average Dosages of Guideline Directed Medical Therapy (GDMT) Aldosterone Antagonists	24.51 mg Standard Deviation 11.62	28.96 mg Standard Deviation 34.12
Average Dosages of Guideline Directed Medical Therapy (GDMT) Beta Blockers	31.91 mg Standard Deviation 24.90	29.92 mg Standard Deviation 25.79
Average Dosages of Guideline Directed Medical Therapy (GDMT) Vasodilators (Nitrate)	59.61 mg Standard Deviation 43.81	42.80 mg Standard Deviation 26.97
Average Dosages of Guideline Directed Medical Therapy (GDMT) Vasodilators (Hydralazine)	139.85 mg Standard Deviation 108.46	109.27 mg Standard Deviation 86.45
Average Dosages of Guideline Directed Medical Therapy (GDMT) ARN Inhibitors	12.64 mg Standard Deviation 9.31	9.65 mg Standard Deviation 6.80

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Average Dosages of GDMT ACE Inhibitors	13.61 mg Standard Deviation 15.01	13.53 mg Standard Deviation 13.68
Average Dosages of GDMT Angiotensin Receptor Blockers (ARBs)	13.68 mg Standard Deviation 9.34	11.89 mg Standard Deviation 8.76
Average Dosages of GDMT Aldosterone Antagonists	24.21 mg Standard Deviation 11.56	29.48 mg Standard Deviation 34.36
Average Dosages of GDMT Beta Blockers	30.12 mg Standard Deviation 24.81	29.25 mg Standard Deviation 25.26
Average Dosages of GDMT Vasodilators (Nitrate)	56.38 mg Standard Deviation 42.76	43.79 mg Standard Deviation 27.15
Average Dosages of GDMT Vasodilators (Hydralazine)	133.41 mg Standard Deviation 108.29	110.53 mg Standard Deviation 87.72
Average Dosages of GDMT ARN Inhibitors	13.17 mg Standard Deviation 11.15	8.85 mg Standard Deviation 5.98

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Average Dosages of GDMT ACE I	13.22 mg Standard Deviation 14.59	12.90 mg Standard Deviation 12.96
Average Dosages of GDMT ARB	13.73 mg Standard Deviation 8.93	12.02 mg Standard Deviation 8.63
Average Dosages of GDMT Aldosterone Antagonists	24.16 mg Standard Deviation 11.19	29.42 mg Standard Deviation 32.68
Average Dosages of GDMT Beta Blockers	30.01 mg Standard Deviation 24.94	28.53 mg Standard Deviation 25.13
Average Dosages of GDMT Vasodilators (Nitrate)	55.48 mg Standard Deviation 41.64	48.59 mg Standard Deviation 34.90
Average Dosages of GDMT Vasodilators (Hydralazine)	133.82 mg Standard Deviation 104.93	109.01 mg Standard Deviation 87.22
Average Dosages of GDMT ARNI	10.13 mg Standard Deviation 8.15	7.68 mg Standard Deviation 4.71

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Average Dosages of GDMT ACE Inhibitors	12.73 mg Standard Deviation 13.56	12.41 mg Standard Deviation 12.82
Average Dosages of GDMT ARBs	13.76 mg Standard Deviation 9.21	11.90 mg Standard Deviation 8.45
Average Dosages of GDMT Aldosterone Antagonists	24.33 mg Standard Deviation 12.17	29.45 mg Standard Deviation 32.58
Average Dosages of GDMT Beta Blockers	30.10 mg Standard Deviation 24.99	28.19 mg Standard Deviation 24.65
Average Dosages of GDMT Vasodilators (Nitrate)	56.85 mg Standard Deviation 41.50	48.56 mg Standard Deviation 34.95
Average Dosages of GDMT Vasodilators (Hydralazine)	136.51 mg Standard Deviation 99.05	108.74 mg Standard Deviation 87.89
Average Dosages of GDMT ARN Inhibitors	10.36 mg Standard Deviation 7.57	7.99 mg Standard Deviation 4.51

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Average Dosages of GDMT ACe Inhibitors	12.35 mg Standard Deviation 13.36	12.32 mg Standard Deviation 12.91
Average Dosages of GDMT ARBs	13.86 mg Standard Deviation 9.10	11.67 mg Standard Deviation 8.09
Average Dosages of GDMT Aldosterone Antagonists	24.36 mg Standard Deviation 12.30	28.98 mg Standard Deviation 32.00
Average Dosages of GDMT Beta Blockers	30.50 mg Standard Deviation 25.15	27.66 mg Standard Deviation 23.70
Average Dosages of GDMT Vasodilators (Nitrate)	54.81 mg Standard Deviation 41.50	45.53 mg Standard Deviation 33.30
Average Dosages of GDMT Vasodilators (Hydralazine)	135.20 mg Standard Deviation 97.01	102.29 mg Standard Deviation 85.28
Average Dosages of GDMT ARN Inhibitors	10.41 mg Standard Deviation 7.34	8.52 mg Standard Deviation 5.40

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Population: All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all thedrugs.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Average Dosages of GDMT ACE Inhibitors	12.23 mg Standard Deviation 13.29	12.28 mg Standard Deviation 12.87
Average Dosages of GDMT ARBs	13.42 mg Standard Deviation 8.88	11.13 mg Standard Deviation 7.87
Average Dosages of GDMT Aldosterone Antagonists	24.24 mg Standard Deviation 11.91	28.97 mg Standard Deviation 31.50
Average Dosages of GDMT Beta Blockers	30.70 mg Standard Deviation 24.66	27.83 mg Standard Deviation 23.79
Average Dosages of GDMT Vasodilators (Nitrate)	53.37 mg Standard Deviation 41.58	44.53 mg Standard Deviation 32.50
Average Dosages of GDMT Vasodilators (Hydralazine)	132.54 mg Standard Deviation 93.88	101.92 mg Standard Deviation 86.30
Average Dosages of GDMT ARN Inhibitors	11.03 mg Standard Deviation 7.25	9.68 mg Standard Deviation 5.89

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 years

Population: All available data has been reported

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Average Dosages of GDMT ACE Inhibitors	12.10 mg Standard Deviation 13.08	12.37 mg Standard Deviation 12.89
Average Dosages of GDMT ARBs	13.28 mg Standard Deviation 8.85	11.03 mg Standard Deviation 7.83
Average Dosages of GDMT Aldosterone Antagonist	24.37 mg Standard Deviation 11.84	29.06 mg Standard Deviation 31.39
Average Dosages of GDMT Beta Blockers	30.59 mg Standard Deviation 24.26	27.78 mg Standard Deviation 23.80
Average Dosages of GDMT Vasodilators (Nitrate)	51.63 mg Standard Deviation 40.59	44.59 mg Standard Deviation 32.55
Average Dosages of GDMT Vasodilators	129.51 mg Standard Deviation 93.77	100.74 mg Standard Deviation 85.36
Average Dosages of GDMT ARN Inhibitors	11.04 mg Standard Deviation 7.29	9.54 mg Standard Deviation 5.77

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 years

Population: All available data has been reported

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Average Dosages of GDMT ACE Inhibitors	12.02 mg Standard Deviation 13.03	12.35 mg Standard Deviation 12.88
Average Dosages of GDMT ARBs	13.29 mg Standard Deviation 8.78	11.02 mg Standard Deviation 7.82
Average Dosages of GDMT Aldosterone Antagonist	24.30 mg Standard Deviation 11.84	28.99 mg Standard Deviation 31.13
Average Dosages of GDMT Beta Blockers	30.60 mg Standard Deviation 24.16	27.78 mg Standard Deviation 23.80
Average Dosages of GDMT Vasodilators Nitrate	52.41 mg Standard Deviation 40.35	44.28 mg Standard Deviation 32.27
Average Dosages of GDMT Vasodilators	130.83 mg Standard Deviation 93.29	100.07 mg Standard Deviation 84.45
Average Dosages of GDMT ARN Inhibitors	11.53 mg Standard Deviation 7.34	9.41 mg Standard Deviation 5.81

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 30 days

Population: Not all subjects were on all the drugs.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
The Number of Subjects With Changes in GDMT Dosage From Baseline ACE-Inhibitors	44 Participants	23 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline Angiotensin-Receptor Blocker (ARBs)	20 Participants	20 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline Aldosterone Antagonists	29 Participants	25 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline Beta Blocker	60 Participants	48 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline Vasodilators (Nitrate)	10 Participants	12 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline Vasodilators (Hydralazine)	11 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 6 months

Population: Not all subjects were on all the drugs.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months ACE-Inhibitors	53 Participants	41 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months Angiotensin-Receptor Blockers (ARBs)	35 Participants	27 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months Aldosterone Antagonists	44 Participants	35 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months Beta Blocker	74 Participants	60 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months Vasodilators (Nitrate)	14 Participants	18 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months Vasodilators (Hydralazine)	15 Participants	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 12 months

Population: Not all subjects were on all the drugs.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months ACE-Inhibitors	61 Participants	37 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months Angiotension-Receptor Blockers (ARBs)	14 Participants	38 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months Aldosterone Antagonists	44 Participants	44 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months Beta Blocker	76 Participants	66 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months Vasodilators (Nitrate)	14 Participants	19 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months Vasodilators (Hydralazine)	14 Participants	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 24 months

Population: Not all subjects were on all the drugs.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months ACE-Inhibitors	36 Participants	24 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months Angiotensin-Receptor Blockers (ARBs)	29 Participants	21 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months Aldosterone Antagonists	28 Participants	21 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months Beta Blockers	43 Participants	34 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months Vasodilators (Nitrate)	7 Participants	11 Participants
The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months Vasodilators (Hydralazine)	10 Participants	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 3 years

Population: Not all subjects were on all the drugs.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline ACE-Inhibitors	44 Participants	25 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline Angiotensin-ReceptorBlockers (ARBs)	40 Participants	26 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline AldosteroneAntagonists	33 Participants	32 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline Beta Blockers	52 Participants	44 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline Vasodilators (Nitrate)	20 Participants	9 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline Vasodilators(Hydralazine)	17 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 4 years

Population: All available data has been reported.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline ACE Inhibitors	31 Participants	21 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline ARBS	39 Participants	27 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline Aldosterone Antagonist	29 Participants	31 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline Beta Blocker	50 Participants	35 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline Vasodilators Nitrate	13 Participants	12 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline Vasodilators	10 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 5 years

Population: All available data has been reported.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline ACE Inhibitors	25 Participants	18 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline ARBs	28 Participants	23 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline Aldosterone Antagonist	27 Participants	15 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline Beta Blocker	40 Participants	33 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline Vasodilators Nitrate	9 Participants	8 Participants
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline Vasodilators	6 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 30 days

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ACE-Inhibitors (Decrease > 50% or Stop)	0 Participants	0 Participants
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ACE-Inhibitors (Increase > 100% or New Class)	1 Participants	1 Participants
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARB (Decrease > 50% or Stop)	1 Participants	0 Participants
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARB (Increase > 100% or New Class)	0 Participants	1 Participants
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Aldosterone Antagonists (Decrease > 50% or stop)	0 Participants	0 Participants
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Aldosterone Antagonists (Increase>100%orNewClass)	2 Participants	2 Participants
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Beta Blockers (Decrease > 50% or Stop)	2 Participants	0 Participants
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Beta Blockers (Increase >100% or New Class)	2 Participants	2 Participants
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators (Nitrate) Decrease>50% or Stop	0 Participants	0 Participants
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators (Nitrate) Increase > 100% or NewClass	1 Participants	0 Participants
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators (Hydralazine) Decrease>50% or Stop	0 Participants	0 Participants
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Hydralazine)Increase >100% orNewClass	1 Participants	1 Participants
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARN Inhibitors - Decrease>50% or Stop	0 Participants	0 Participants
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARN Inhibitors - Increase > 100% or NewClass	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 6 months

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ACE-I (Decrease > 50% or Stop)	8 Participants	4 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ACE-I (Increase > 100% or New Class)	6 Participants	4 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARB (Decrease > 50% or Stop)	2 Participants	1 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARB (Increase > 100% or New Class)	7 Participants	9 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Aldosterone Antagonists (Decrease > 50% or Stop)	1 Participants	1 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Aldosterone Antagonists (Increase > 100% or NewCl)	11 Participants	7 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Beta Blockers (Decrease > 50% or Stop)	14 Participants	10 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Beta Blockers (Increase > 100% or New Class)	19 Participants	9 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators (Nitrate) Decrease > 50% or Stop	0 Participants	0 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators (Nitrate) Increase > 100% or NewClass	1 Participants	5 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators (Hydralazine) Decrease > 50% or Stop	1 Participants	0 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Hydralazine)Increase>100% orNewClass	7 Participants	6 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARN Inhibitors Decrease > 50% or Stop	0 Participants	0 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARN Inhibitors Increase > 100% or New Class	6 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 12 months

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ACE-Inhibitors Decrease > 50% or Stop	13 Participants	5 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ACE-Inhibitors Increase > 100% or New Class	9 Participants	8 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARBs Decrease >50% or Stop	3 Participants	2 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARBs Increase > 100% or New Class	13 Participants	12 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Aldosterone Antagonists Decrease > 50% or Stop	2 Participants	2 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Aldosterone Antagonists Increase>100% or New Class	16 Participants	8 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Beta Blockers Decrease > 50% or Stop	16 Participants	16 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Beta Blockers Increase > 100% or New Class	26 Participants	12 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Nitrate) Decrease > 50% or Stop	0 Participants	0 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Nitrate) Increase > 100% or New Class	3 Participants	6 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Hydralazine) Decrease > 50% or Stop	3 Participants	0 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Hydralazine) Increase>100%orNewClass	13 Participants	12 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARN Inhibitors Decrease > 50% or Stop	0 Participants	0 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARN inhibitors Increase > 100% or New Class	13 Participants	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 24 months

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ACE-Inhibitors Decrease > 50% or Stop	17 Participants	6 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ACE Inhibitors Increase > 100% or New Class	14 Participants	11 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARBs Decrease > 50% or Stop	3 Participants	2 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARBs Increase > 100% or New Class	19 Participants	16 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Aldosterone Antagonists Decrease > 50% or Stop	2 Participants	3 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Aldosterone Antagonists Increase>100% or New Class	21 Participants	10 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Beta Blockers Decrease > 50% or Stop	20 Participants	26 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Beta Blockers Increase > 100% or New Class	29 Participants	19 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Nitrate) Decrease > 50% or Stop	0 Participants	1 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Nitrate) Increase > 100% or New Class	5 Participants	11 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Hydralazine)Decrease > 50% or Stop	6 Participants	1 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Hydralazine) Increase>100%orNew Class	14 Participants	20 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARN Inhibitors Decrease > 50% or Stop	0 Participants	0 Participants
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARN Inhibitors Increase > 100% or New Class	26 Participants	24 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 3 years

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ACE-Inhibitors Decrease > 50% orStop	19 Participants	7 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ACE Inhibitors Increase > 100% orNew Class	15 Participants	12 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARBs Decrease > 50% or Stop	4 Participants	3 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARBs Increase > 100% or NewClass	22 Participants	19 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Aldosterone Antagonists Decrease> 50% or Stop	3 Participants	5 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Aldosterone AntagonistsIncrease>100% or New Class	27 Participants	14 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Beta Blockers Decrease > 50% orStop	25 Participants	29 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Beta Blockers Increase > 100% orNew Class	32 Participants	26 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Nitrate) Decrease >50% or Stop	0 Participants	1 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Nitrate) Increase >100% or New Class	6 Participants	13 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Hydralazine)Decrease> 50% or Stop	7 Participants	1 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Hydralazine)Increase>100%orNew Class	19 Participants	24 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARN Inhibitors Decrease > 50% orStop	0 Participants	0 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARN Inhibitors Increase > 100% orNew Class	45 Participants	29 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 4 years

Population: All available data has been reported.

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ACE-Inhibitors Decrease > 50% orStop	20 Participants	7 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ACE Inhibitors Increase > 100% orNew Class	18 Participants	12 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARBs Decrease > 50% or Stop	5 Participants	3 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARBs Increase > 100% or NewClass	25 Participants	21 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Aldosterone Antagonists Decrease> 50% or Stop	3 Participants	5 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Aldosterone AntagonistsIncrease>100% or New Class	32 Participants	15 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Beta Blockers Decrease > 50% orStop	29 Participants	32 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Beta Blockers Increase > 100% orNew Class	35 Participants	26 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Nitrate) Decrease >50% or Stop	0 Participants	1 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Nitrate) Increase >100% or New Class	7 Participants	14 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Hydralazine)Decrease> 50% or Stop	7 Participants	3 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Hydralazine)Increase>100%orNew Class	21 Participants	26 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARN Inhibitors Decrease > 50% orStop	0 Participants	0 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARN Inhibitors Increase > 100% orNew Class	57 Participants	33 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 5 years

Outcome measures

Measure	MitraClip System n=302 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ACE-Inhibitors Decrease > 50% orStop	20 Participants	7 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ACE Inhibitors Increase > 100% orNew Class	18 Participants	14 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARBs Decrease > 50% or Stop	5 Participants	3 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARBs Increase > 100% or NewClass	26 Participants	22 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Aldosterone Antagonists Decrease> 50% or Stop	4 Participants	5 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Aldosterone AntagonistsIncrease>100% or New Class	33 Participants	16 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Beta Blockers Decrease > 50% orStop	30 Participants	34 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Beta Blockers Increase > 100% orNew Class	35 Participants	27 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Nitrate) Decrease >50% or Stop	0 Participants	1 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Nitrate) Increase >100% or New Class	9 Participants	15 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Hydralazine)Decrease> 50% or Stop	8 Participants	3 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose Vasodilators(Hydralazine)Increase>100%orNew Class	22 Participants	27 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARN Inhibitors Decrease > 50% orStop	1 Participants	0 Participants
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose ARN Inhibitors Increase > 100% orNew Class	62 Participants	34 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: A total of 14 subjects were enrolled in the CPA sub study. However CPX data was available for only 2 subjects in the device group and 1 subject in the control group.

A substudy endpoint will utilize peak oxygen consumption oxygen uptake (VO2) as a parameter for cardiopulmonary exercise testing on a total of at least 50 and up to 100 subjects.

The CPX analysis variables are:

• Peak VO2 (ml/kg/min) - CPX Sub-study endpoint, descriptive analysis only, not powered for statistical significance
• Exercise duration (min)
• Peak workload (watts)
• Maximum heart rate during exercise (beats/min)
• Peak VE (l/min)
• Respiratory Exchange Ratio (RER, VCO2/VO2)
• VE/VCO2 slope
• Ventilatory Threshold (ml/kg/min)
• Borg scale
• Exercise termination reason
• Type of exercise (treadmill vs cycling)

Outcome measures

Measure	MitraClip System n=2 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=1 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Cardiopulmonary Exercise (CPX) Testing	12.85 ml/kg/min Standard Deviation 0.78	6.00 ml/kg/min Standard Deviation NA Data is available for only one subject. Hence Standard deviation is not applicable.

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: A total of 14 subjects participated in the CPX sub-study. CPX test data was available in 2 subjects in the device group and 1 subject in the control group.

A substudy endpoint will utilize peak oxygen consumption oxygen uptake (VO2) as a parameter for cardiopulmonary exercise testing on a total of at least 50 and up to 100 subjects.

The CPX analysis variables are:

• Peak VO2 (ml/kg/min) - CPX Sub-study endpoint, descriptive analysis only, not powered for statistical significance
• Exercise duration (min)
• Peak workload (watts)
• Maximum heart rate during exercise (beats/min)
• Peak VE (l/min)
• Respiratory Exchange Ratio (RER, VCO2/VO2)
• VE/VCO2 slope
• Ventilatory Threshold (ml/kg/min)
• Borg scale
• Exercise termination reason
• Type of exercise (treadmill vs cycling)

Outcome measures

Measure	MitraClip System n=2 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=1 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Cardiopulmonary Exercise (CPX) Testing	14.50 ml/kg/min Standard Deviation 6.36	6.80 ml/kg/min Standard Deviation NA Data available for only 1 subject. Hence Standard deviation is not possible.

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 12 months

Population: A total of 14 subjects participated in the CPX sub-study. CPX test data was available in 2 subjects in the device group and 1 subject in the control group.

Mean changes in peak VO2 (ml/kg/min) will be summarized at 12 months from baseline for the subset of patients who complete a CPX test at baseline and 12 months. A comparison of change from baseline between Device and Control groups will be presented.

The CPX analysis variables are:

• Peak VO2 (ml/kg/min) - CPX Sub-study endpoint, descriptive analysis only, not powered for statistical significance
• Exercise duration (min)
• Peak workload (watts)
• Maximum heart rate during exercise (beats/min)
• Peak VE (l/min)
• Respiratory Exchange Ratio (RER, VCO2/VO2)
• VE/VCO2 slope
• Ventilatory Threshold (ml/kg/min)
• Borg scale
• Exercise termination reason
• Type of exercise (treadmill vs cycling)

Outcome measures

Measure	MitraClip System n=2 Participants Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=1 Participants Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Cardiopulmonary Exercise (CPX) Testing: Mean Changes in Peak VO2	1.65 ml/kg/min Standard Deviation 5.59	0.80 ml/kg/min Standard Deviation NA Data is available for only 1 subject.

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 5 years

Outcome measures

Outcome data not reported

Adverse Events

MitraClip System

Serious events: 281 serious events

Other events: 239 other events

Deaths: 167 deaths

Control Group

Serious events: 291 serious events

Other events: 234 other events

Deaths: 192 deaths

COAPT CAS Group

Serious events: 0 serious events

Other events: 86 other events

Deaths: 46 deaths

Serious adverse events

Measure	MitraClip System n=302 participants at risk Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 participants at risk Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.	COAPT CAS Group n=162 participants at risk subjects enrolled as part of the Continued Access Study with Percutaneous mitral valve repair using MitraClip System
Nervous system disorders HEADACHE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders HEPATIC ENCEPHALOPATHY	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders HYPOAESTHESIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders DYSARTHRIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations PYELONEPHRITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations RESPIRATORY TRACT INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations SEPSIS	6.0% 18/302 • Number of events 20 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	4.2% 13/312 • Number of events 15 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations SEPSIS SYNDROME	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations SEPTIC SHOCK	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.9% 9/312 • Number of events 9 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations SOFT TISSUE INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders EMBOLIC STROKE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders ENCEPHALOPATHY	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders Anaemia	8.3% 25/302 • Number of events 30 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.8% 12/312 • Number of events 14 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders Anaemia Macrocytic	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders Anaemia of Chronic Disease	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders Coagulopathy	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders Haemorrhagic Anaemia	2.3% 7/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders LEUKOCYTOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders MICROCYTIC ANAEMIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders PANCYTOPENIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ACUTE CORONARY SYNDROME	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ACUTE LEFT VENTRICULAR FAILURE	5.3% 16/302 • Number of events 19 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.9% 9/312 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	4.6% 14/302 • Number of events 16 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	6.7% 21/312 • Number of events 25 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ANGINA PECTORIS	1.7% 5/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ANGINA UNSTABLE	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ARRHYTHMIA	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ARTERIOSCLEROSIS CORONARY ARTERY	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ATRIAL FIBRILLATION	9.3% 28/302 • Number of events 37 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	8.3% 26/312 • Number of events 33 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ATRIAL FLUTTER	2.3% 7/302 • Number of events 9 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.2% 7/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ATRIAL SEPTAL DEFECT ACQUIRED	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ATRIAL TACHYCARDIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ATRIAL THROMBOSIS	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders BRADYCARDIA	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIAC ARREST	5.3% 16/302 • Number of events 17 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	9.0% 28/312 • Number of events 28 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIAC FAILURE	13.9% 42/302 • Number of events 55 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	31.4% 98/312 • Number of events 133 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIAC FAILURE ACUTE	11.6% 35/302 • Number of events 45 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	12.5% 39/312 • Number of events 51 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIAC FAILURE CHRONIC	13.6% 41/302 • Number of events 56 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	17.9% 56/312 • Number of events 69 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIAC FAILURE CONGESTIVE	29.5% 89/302 • Number of events 136 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	33.7% 105/312 • Number of events 193 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIAC TAMPONADE	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIO-RESPIRATORY ARREST	2.6% 8/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.2% 7/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIOGENIC SHOCK	4.0% 12/302 • Number of events 14 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	6.4% 20/312 • Number of events 20 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIOMYOPATHY	1.3% 4/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIOPULMONARY FAILURE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIORENAL SYNDROME	0.66% 2/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIOVASCULAR DECONDITIONING	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CONGESTIVE CARDIOMYOPATHY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CORONARY ARTERY DISEASE	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CORONARY ARTERY OCCLUSION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CORONARY ARTERY STENOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders INTRACARDIAC THROMBUS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ISCHAEMIC CARDIOMYOPATHY	2.6% 8/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.9% 9/312 • Number of events 9 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders LEFT VENTRICULAR DYSFUNCTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders LEFT VENTRICULAR FAILURE	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders MITRAL VALVE INCOMPETENCE	2.6% 8/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	4.5% 14/312 • Number of events 15 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders MITRAL VALVE STENOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders MYOCARDIAL INFARCTION	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.66% 2/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders PALPITATIONS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders PERICARDIAL EFFUSION	2.6% 8/302 • Number of events 9 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders PERICARDIAL HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders SICK SINUS SYNDROME	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders SYSTOLIC DYSFUNCTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders TACHYARRHYTHMIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders TACHYCARDIA	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders TORSADE DE POINTES	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders TRICUSPID VALVE INCOMPETENCE	1.7% 5/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders VENTRICULAR ARRHYTHMIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders VENTRICULAR DYSSYNCHRONY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders VENTRICULAR FIBRILLATION	1.7% 5/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.6% 8/312 • Number of events 9 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders VENTRICULAR TACHYCARDIA	7.0% 21/302 • Number of events 34 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	8.3% 26/312 • Number of events 40 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Ear and labyrinth disorders VERTIGO	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders CATARACT	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders CONJUNCTIVITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders DIPLOPIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders VISION BLURRED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ABDOMINAL PAIN	1.3% 4/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ACQUIRED OESOPHAGEAL WEB	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ASCITES	1.7% 5/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders COLITIS	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders COLITIS ISCHAEMIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders COLITIS ULCERATIVE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders COLONIC PSEUDO-OBSTRUCTION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders CONSTIPATION	0.33% 1/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DIABETIC GASTROPARESIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DIARRHOEA	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DIVERTICULAR PERFORATION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DIVERTICULUM INTESTINAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DIVERTICULUM INTESTINAL HAEMORRHAGIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DYSPHAGIA	2.3% 7/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ENTEROCUTANEOUS FISTULA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ENTEROVESICAL FISTULA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders EROSIVE OESOPHAGITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders FLATULENCE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders GASTRITIS HAEMORRHAGIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders GASTROINTESTINAL ANGIODYSPLASIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	6.0% 18/302 • Number of events 21 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	6.4% 20/312 • Number of events 24 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders HAEMATEMESIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders HAEMORRHOIDAL HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders HAEMORRHOIDS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders HIATUS HERNIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders IMPAIRED GASTRIC EMPTYING	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders INGUINAL HERNIA	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders INGUINAL HERNIA, OBSTRUCTIVE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders INTESTINAL ISCHAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders INTESTINAL PERFORATION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders JEJUNITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders LARGE INTESTINE PERFORATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders LOWER GASTROINTESTINAL HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders MEGACOLON	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders MELAENA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders NAUSEA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ODYNOPHAGIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders OESOPHAGEAL ULCER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders PANCREATITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders PANCREATITIS ACUTE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders PROCTALGIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders PROCTITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders RECTAL HAEMORRHAGE	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders RECTAL PROLAPSE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders RECTAL ULCER	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders RECTAL ULCER HAEMORRHAGE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders RETROPERITONEAL HAEMATOMA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders RETROPERITONEAL HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders UMBILICAL HERNIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	1.3% 4/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders VOLVULUS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders VOMITING	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders ADVERSE DRUG REACTION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders ASTHENIA	1.7% 5/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders CATHETER SITE HAEMATOMA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders CATHETER SITE HAEMORRHAGE	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders CHEST DISCOMFORT	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders CHEST PAIN	3.3% 10/302 • Number of events 14 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.2% 10/312 • Number of events 14 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEATH	4.0% 12/302 • Number of events 12 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.8% 12/312 • Number of events 12 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE BATTERY ISSUE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE DISLOCATION	2.3% 7/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE ELECTRICAL FINDING	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE LEAD DAMAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE LEAD ISSUE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE MALFUNCTION	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DRUG INTOLERANCE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders EXERCISE TOLERANCE DECREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders FATIGUE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.33% 1/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders HAEMORRHAGE INTRACRANIAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders HERNIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders HERNIA OBSTRUCTIVE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders MEDICAL DEVICE COMPLICATION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders MULTI-ORGAN FAILURE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders NON-CARDIAC CHEST PAIN	2.3% 7/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.2% 7/312 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders OEDEMA PERIPHERAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders PYREXIA	1.7% 5/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders SUDDEN CARDIAC DEATH	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders VESSEL PUNCTURE SITE HAEMATOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders BILE DUCT STONE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders CHOLECYSTITIS	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders CHOLECYSTITIS ACUTE	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders CHOLELITHIASIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders HEPATIC CIRRHOSIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders HEPATIC MASS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders ISCHAEMIC HEPATITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Immune system disorders ANAPHYLACTIC REACTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Immune system disorders HEART TRANSPLANT REJECTION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Immune system disorders IMMUNOSUPPRESSION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Immune system disorders TRANSPLANT REJECTION	0.33% 1/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ABDOMINAL ABSCESS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ABSCESS LIMB	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ACQUIRED IMMUNODEFICIENCY SYNDROME	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations BACTERAEMIA	1.7% 5/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations BACTERIAL SEPSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations BRONCHITIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations BRONCHITIS VIRAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations BRONCHOPNEUMONIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations CELLULITIS	3.3% 10/302 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations CLOSTRIDIAL INFECTION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	0.66% 2/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations CYSTITIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations DEVICE RELATED INFECTION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations DEVICE RELATED SEPSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations DIVERTICULITIS	1.7% 5/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations EMPHYSEMATOUS CYSTITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ENTEROCOCCAL BACTERAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ENTEROCOLITIS INFECTIOUS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ESCHERICHIA BACTERAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ESCHERICHIA INFECTION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations FUNGAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations GANGRENE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations GASTROENTERITIS VIRAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations HERPES ZOSTER	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations IMPLANT SITE INFECTION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations INFLUENZA	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations INFUSION SITE CELLULITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations KLEBSIELLA BACTERAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations LOBAR PNEUMONIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations OESOPHAGEAL INFECTION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations OSTEOMYELITIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations PARAINFLUENZAE VIRUS INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations PERIRECTAL ABSCESS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations PERITONITIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations PNEUMONIA	8.9% 27/302 • Number of events 33 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	9.0% 28/312 • Number of events 32 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations PNEUMONIA BACTERIAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations PNEUMONIA INFLUENZAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations PNEUMONIA NECROTISING	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations PNEUMONIA STAPHYLOCOCCAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations POST VIRAL FATIGUE SYNDROME	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations PULMONARY SEPSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations STAPHYLOCOCCAL BACTERAEMIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations STAPHYLOCOCCAL INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations STREPTOCOCCAL BACTERAEMIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations SUBCUTANEOUS ABSCESS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations TRACHEOBRONCHITIS VIRAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations TUBERCULOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations URINARY TRACT INFECTION	1.3% 4/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations URINARY TRACT INFECTION BACTERIAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations URINARY TRACT INFECTION FUNGAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations UROSEPSIS	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications ANAEMIA POSTOPERATIVE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications ANAESTHETIC COMPLICATION PULMONARY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA THROMBOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications ARTHROPOD BITE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications CARDIAC VALVE REPLACEMENT COMPLICATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications CERVICAL VERTEBRAL FRACTURE	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications COMPLICATIONS OF TRANSPLANTED HEART	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications CONTUSION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications CRANIOCEREBRAL INJURY	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications FACE INJURY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications FACIAL BONES FRACTURE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications FALL	4.6% 14/302 • Number of events 14 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	4.8% 15/312 • Number of events 15 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications FEMUR FRACTURE	1.7% 5/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications FRACTURE DISPLACEMENT	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications FRACTURED SACRUM	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications GASTROENTERITIS RADIATION	0.33% 1/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications HAEMATURIA TRAUMATIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications HEAD INJURY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications HIP FRACTURE	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.6% 8/312 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications IN-STENT CORONARY ARTERY RESTENOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications INJURY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications LACERATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications PELVIC FRACTURE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications POCKET EROSION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications POST PROCEDURAL HAEMATOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications POSTOPERATIVE ILEUS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications PROCEDURAL COMPLICATION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications PROCEDURAL HAEMORRHAGE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications PROCEDURAL HYPOTENSION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications PUBIS FRACTURE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications RADIUS FRACTURE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications RENAL HAEMATOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications RIB FRACTURE	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications SPINAL FRACTURE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications TOXICITY TO VARIOUS AGENTS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications TRAUMATIC HAEMATOMA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications TRAUMATIC INTRACRANIAL HAEMORRHAGE	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications VASCULAR ACCESS COMPLICATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications VENA CAVA INJURY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications WOUND	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC	0.99% 3/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations CARDIAC ENZYMES INCREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations CARDIAC OUTPUT DECREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations CATHETERISATION CARDIAC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations COLONOSCOPY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations DRUG LEVEL ABOVE THERAPEUTIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations EJECTION FRACTION DECREASED	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations ELECTROCARDIOGRAM AMBULATORY ABNORMAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations ELECTROCARDIOGRAM QRS COMPLEX PROLONGED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations ELECTROCARDIOGRAM QT PROLONGED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations ELECTROCARDIOGRAM ST SEGMENT ELEVATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations ENTEROCOCCUS TEST POSITIVE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations HAEMOGLOBIN DECREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations INFLUENZA A VIRUS TEST POSITIVE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations INTERNATIONAL NORMALISED RATIO DECREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations LABORATORY TEST ABNORMAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations LIVER FUNCTION TEST ABNORMAL	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations TRANSAMINASES INCREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations TROPONIN INCREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations URINE OUTPUT DECREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations WHITE BLOOD CELL COUNT INCREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders ACIDOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders DEHYDRATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders DIABETES MELLITUS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders DIABETIC KETOACIDOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders ELECTROLYTE IMBALANCE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders FAILURE TO THRIVE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders FLUID OVERLOAD	2.0% 6/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders GOUT	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPERKALAEMIA	2.3% 7/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPOGLYCAEMIA	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPOKALAEMIA	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPONATRAEMIA	1.3% 4/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPOVOLAEMIA	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders IRON DEFICIENCY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders LACTIC ACIDOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders METABOLIC ACIDOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders METABOLIC ALKALOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders ARTHRITIS	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders BACK PAIN	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders CERVICAL SPINAL STENOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders GOUTY ARTHRITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DEGENERATION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders MUSCLE HAEMORRHAGE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders NECK PAIN	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	2.3% 7/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders SPINAL COLUMN STENOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders VERTEBRAL FORAMINAL STENOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANGIOSARCOMA METASTATIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-CELL LYMPHOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BONE SARCOMA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC NEOPLASM MALIGNANT	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LEUKAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA METASTATIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CANCER METASTATIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MULTIPLE MYELOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL ADENOCARCINOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL CARCINOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OVARIAN CANCER METASTATIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN CANCER	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID CANCER	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders CAROTID ARTERY DISEASE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders CAROTID ARTERY STENOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders CARPAL TUNNEL SYNDROME	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders CEREBRAL HAEMORRHAGE	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders CEREBROVASCULAR ACCIDENT	5.3% 16/302 • Number of events 17 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.5% 11/312 • Number of events 12 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders CERVICOBRACHIAL SYNDROME	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders CONVULSION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders DEMENTIA ALZHEIMER'S TYPE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders DIZZINESS	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders DIZZINESS POSTURAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders HYPOXIC-ISCHAEMIC ENCEPHALOPATHY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders INTRACRANIAL ANEURYSM	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders INTRACRANIAL HYPOTENSION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders ISCHAEMIC STROKE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders LOSS OF CONSCIOUSNESS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders METABOLIC ENCEPHALOPATHY	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders PARKINSON'S DISEASE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders PRESYNCOPE	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders SCIATICA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders SYNCOPE	4.6% 14/302 • Number of events 16 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	7.1% 22/312 • Number of events 24 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders TOXIC ENCEPHALOPATHY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders VERTEBRAL ARTERY OCCLUSION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders CONFUSIONAL STATE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders DELIRIUM	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders DISORIENTATION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders MENTAL STATUS CHANGES	3.3% 10/302 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders PANIC ATTACK	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders AZOTAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders DYSURIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders HAEMATURIA	1.7% 5/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders NEPHROLITHIASIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders NEPHROPATHY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders RENAL FAILURE	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.2% 10/312 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders RENAL FAILURE ACUTE	13.6% 41/302 • Number of events 49 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	16.3% 51/312 • Number of events 60 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders RENAL FAILURE CHRONIC	4.0% 12/302 • Number of events 15 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	6.4% 20/312 • Number of events 21 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders RENAL IMPAIRMENT	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders RENAL MASS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders URINARY RETENTION	1.7% 5/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.66% 2/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISTRESS SYNDROME	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	6.3% 19/302 • Number of events 22 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	4.5% 14/312 • Number of events 14 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders ASTHMA	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders BRONCHIAL SECRETION RETENTION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISORDER	3.3% 10/302 • Number of events 18 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.2% 10/312 • Number of events 16 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders COUGH	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders DYSPHONIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders DYSPNOEA	7.6% 23/302 • Number of events 29 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	5.1% 16/312 • Number of events 18 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders EPISTAXIS	2.0% 6/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders HAEMOTHORAX	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders HYPERCAPNIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders INCREASED UPPER AIRWAY SECRETION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders LARYNGEAL HAEMATOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders MEDIASTINAL HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	3.6% 11/302 • Number of events 17 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	4.5% 14/312 • Number of events 18 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	1.7% 5/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PULMONARY CONGESTION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders RALES	0.33% 1/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	4.3% 13/302 • Number of events 13 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	6.1% 19/312 • Number of events 19 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders SLEEP APNOEA SYNDROME	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders ANGIOEDEMA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders DIGITAL ULCER	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders RASH	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders SKIN DISCOLOURATION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders SKIN ULCER	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures AORTIC SURGERY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures CARDIAC PACEMAKER BATTERY REPLACEMENT	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures CARDIAC PACEMAKER REPLACEMENT	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures CHOLECYSTECTOMY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures GASTRECTOMY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures HEART TRANSPLANT	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures HIP ARTHROPLASTY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures IMPLANTABLE DEFIBRILLATOR INSERTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures IMPLANTABLE DEFIBRILLATOR REPLACEMENT	0.66% 2/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures INGUINAL HERNIA REPAIR	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures MEDICAL DEVICE CHANGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures PERCUTANEOUS CORONARY INTERVENTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures SPINAL FUSION SURGERY	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders ANGIOPATHY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders AORTIC ANEURYSM	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders AORTIC STENOSIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders ARTERIOSCLEROSIS	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders DEEP VEIN THROMBOSIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders FEMORAL ARTERIAL STENOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders HAEMATOMA	1.7% 5/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders HAEMODYNAMIC INSTABILITY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders HYPOTENSION	7.9% 24/302 • Number of events 27 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	5.8% 18/312 • Number of events 19 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders HYPOVOLAEMIC SHOCK	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders ILIAC ARTERY STENOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders INTERMITTENT CLAUDICATION	0.33% 1/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders ORTHOSTATIC HYPOTENSION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders PERIPHERAL ARTERY ANEURYSM	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders PERIPHERAL ISCHAEMIA	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders PERIPHERAL VASCULAR DISORDER	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders SHOCK	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders SHOCK HAEMORRHAGIC	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders NORMOCHROMIC NORMOCYTIC ANAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ACUTE RIGHT VENTRICULAR FAILURE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ARRHYTHMIA SUPRAVENTRICULAR	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Endocrine disorders HYPOTHYROIDISM	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders BUNDLE BRANCH BLOCK LEFT	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIAC PERFORATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CHRONIC LEFT VENTRICULAR FAILURE	0.99% 3/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders LOW CARDIAC OUTPUT SYNDROME	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders MITRAL VALVE DISEASE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders RIGHT VENTRICULAR FAILURE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders BLINDNESS UNILATERAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders EYE HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ABDOMINAL DISTENSION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DUODENAL VASCULAR ECTASIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders GASTROINTESTINAL VASCULAR MALFORMATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders LOCALISED INTRAABDOMINAL FLUID COLLECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders OESOPHAGEAL STENOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders OESOPHAGITIS HAEMORRHAGIC	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders TOOTHACHE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders CYST	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE OCCLUSION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders HYPOTHERMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders IMPLANT SITE HAEMATOMA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders ISCHAEMIC ULCER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders MASS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders THROMBOSIS IN DEVICE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders ACUTE HEPATIC FAILURE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders CARDIAC CIRRHOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders NON-ALCOHOLIC STEATOHEPATITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations AMERICAN TRYPANOSOMIASIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations APPENDICITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations CORONA VIRUS INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ESCHERICHIA SEPSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations GASTROENTERITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations LUNG INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations LUNG INFECTION PSEUDOMONAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations TRACHEOBRONCHITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations VIRAL INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications BLADDER INJURY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications FOOT FRACTURE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications LIMB INJURY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications LIP INJURY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications LOWER LIMB FRACTURE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations BARIUM SWALLOW ABNORMAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations BRAIN NATRIURETIC PEPTIDE INCREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations CARDIAC MONITORING	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations NOROVIRUS TEST POSITIVE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations RESPIRATORY SYNCYTIAL VIRUS TEST POSITIVE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders DIABETES MELLITUS INADEQUATE CONTROL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPERCALCAEMIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders MALNUTRITION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders FRACTURE MALUNION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders JOINT EFFUSION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders OSTEOLYSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER METASTATIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC CANCER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIPOMA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.66% 2/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM MALIGNANT	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ONCOLOGIC COMPLICATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OROPHARYNGEAL CANCER STAGE UNSPECIFIED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER METASTATIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CELL CARCINOMA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders DURAL FISTULA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders ISCHAEMIC CEREBRAL INFARCTION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders HYDRONEPHROSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders PROTEINURIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders RENAL DISORDER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders URINARY TRACT OBSTRUCTION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Reproductive system and breast disorders PROSTATIC HAEMORRHAGE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders ORGANISING PNEUMONIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PULMONARY HILUM MASS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders TRACHEOMALACIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders CUTIS LAXA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders PANNICULITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders HYPERTENSION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders THROMBOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders VENOUS OCCLUSION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Endocrine disorders ADRENAL INSUFFICIENCY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA SITE HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations BLOOD POTASSIUM DECREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations WEIGHT DECREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT PLEURAL EFFUSION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE CARCINOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders HAEMORRHAGIC STROKE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders BLADDER MASS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders PERIPHERAL EMBOLISM	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	— 0/0 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group

Other adverse events

Measure	MitraClip System n=302 participants at risk Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Control Group n=312 participants at risk Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.	COAPT CAS Group n=162 participants at risk subjects enrolled as part of the Continued Access Study with Percutaneous mitral valve repair using MitraClip System
Injury, poisoning and procedural complications FROSTBITE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications HAEMATURIA TRAUMATIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications HAND FRACTURE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications JOINT INJURY	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications LACERATION	4.0% 12/302 • Number of events 15 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.9% 9/312 • Number of events 9 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders RIGHT VENTRICULAR FAILURE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications HEAD INJURY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications IN-STENT CORONARY ARTERY RESTENOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications INJURY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIAC FAILURE CONGESTIVE	5.3% 16/302 • Number of events 17 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	6.7% 21/312 • Number of events 31 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIOGENIC SHOCK	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CYANOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders INTRACARDIAC THROMBUS	1.7% 5/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications INTENTIONAL OVERDOSE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ISCHAEMIC CARDIOMYOPATHY	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders LEFT VENTRICULAR DYSFUNCTION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications INTERVERTEBRAL DISC INJURY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications JAW FRACTURE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders MITRAL VALVE INCOMPETENCE	3.0% 9/302 • Number of events 11 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders MITRAL VALVE STENOSIS	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders PALPITATIONS	2.0% 6/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders PERICARDIAL EFFUSION	1.7% 5/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders ANAEMIA	6.0% 18/302 • Number of events 19 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	6.4% 20/312 • Number of events 22 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders ANAEMIA FOLATE DEFICIENCY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders ANAEMIA MACROCYTIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders ANAEMIA OF CHRONIC DISEASE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders COAGULOPATHY	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders HAEMORRHAGIC ANAEMIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders LEUKOCYTOSIS	0.99% 3/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders LYMPHADENOPATHY MEDIASTINAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders MACROCYTOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders MICROCYTIC ANAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders NEPHROGENIC ANAEMIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders NORMOCHROMIC NORMOCYTIC ANAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders PANCYTOPENIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders SPLENIC INFARCTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders SPLENOMEGALY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Blood and lymphatic system disorders THROMBOCYTOPENIA	2.6% 8/302 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ANGINA PECTORIS	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ANGINA UNSTABLE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ARRHYTHMIA	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ATRIAL FIBRILLATION	7.6% 23/302 • Number of events 28 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	5.1% 16/312 • Number of events 19 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.2% 2/162 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ATRIAL FLUTTER	0.66% 2/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ATRIAL SEPTAL DEFECT ACQUIRED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ATRIAL TACHYCARDIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ATRIAL THROMBOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders BRADYCARDIA	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIAC ARREST	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.62% 1/162 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIAC FAILURE	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.9% 9/312 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIAC FAILURE ACUTE	1.7% 5/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.2% 7/312 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CARDIAC FAILURE CHRONIC	1.7% 5/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders SICK SINUS SYNDROME	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders SINUS TACHYCARDIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders TACHYCARDIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders TRICUSPID VALVE INCOMPETENCE	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders VENTRICULAR ARRHYTHMIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders VENTRICULAR FIBRILLATION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders VENTRICULAR TACHYCARDIA	6.0% 18/302 • Number of events 20 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.6% 8/312 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Congenital, familial and genetic disorders ATRIAL SEPTAL DEFECT	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Ear and labyrinth disorders DEAFNESS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Ear and labyrinth disorders DEAFNESS NEUROSENSORY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Ear and labyrinth disorders DEAFNESS UNILATERAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Ear and labyrinth disorders EAR HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Ear and labyrinth disorders VERTIGO	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Endocrine disorders HYPERPARATHYROIDISM	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Endocrine disorders HYPERTHYROIDISM	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Endocrine disorders HYPOTHYROIDISM	1.3% 4/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Endocrine disorders THYROIDITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders BLEPHARITIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders CATARACT	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders CONJUNCTIVAL HAEMORRHAGE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders DIPLOPIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders EYE HAEMORRHAGE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders EYE PAIN	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders EYELID PTOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders RETINAL VASCULAR OCCLUSION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders VISION BLURRED	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ABDOMINAL DISTENSION	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ABDOMINAL MASS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ABDOMINAL PAIN	3.0% 9/302 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ABDOMINAL PAIN LOWER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ASCITES	1.7% 5/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders COLITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders CONSTIPATION	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.2% 7/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DENTAL CARIES	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DIVERTICULUM INTESTINAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DIVERTICULUM INTESTINAL HAEMORRHAGIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DRY MOUTH	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DUODENAL ULCER	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DYSPHAGIA	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders FAECAL INCONTINENCE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders GASTRIC POLYPS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders GASTRIC ULCER	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders GASTRITIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders GINGIVAL BLEEDING	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders HAEMATEMESIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders HAEMATOCHEZIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders HAEMORRHOIDAL HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders HAEMORRHOIDS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ILEUS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders IMPAIRED GASTRIC EMPTYING	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders INGUINAL HERNIA	0.66% 2/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders INGUINAL HERNIA, OBSTRUCTIVE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders INTESTINAL MASS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders MELAENA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders MOUTH HAEMORRHAGE	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders NAUSEA	2.3% 7/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.6% 8/312 • Number of events 11 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ODYNOPHAGIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders OESOPHAGEAL HYPOMOTILITY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders PAROTID GLAND INFLAMMATION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders POOR DENTAL CONDITION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders PROCTALGIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders SALIVARY GLAND DISORDER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders TONGUE ULCERATION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders TOOTHACHE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders VOMITING	1.7% 5/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	4.5% 14/312 • Number of events 16 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders ADVERSE DRUG REACTION	3.3% 10/302 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.2% 10/312 • Number of events 11 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders APPLICATION SITE PAIN	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders ASTHENIA	2.3% 7/302 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.2% 7/312 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders CATHETER SITE DISCHARGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders CATHETER SITE HAEMATOMA	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders CATHETER SITE HAEMORRHAGE	5.3% 16/302 • Number of events 16 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders CATHETER SITE INFLAMMATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders CATHETER SITE PAIN	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders CHEST DISCOMFORT	1.3% 4/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders CHEST PAIN	2.6% 8/302 • Number of events 13 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	4.2% 13/312 • Number of events 15 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders CYST	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE BATTERY ISSUE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE CAPTURING ISSUE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE DISLOCATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE ELECTRICAL FINDING	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE INFUSION ISSUE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE ISSUE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE LEAD DAMAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE MALFUNCTION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE STIMULATION ISSUE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders EXERCISE TOLERANCE DECREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders FATIGUE	4.6% 14/302 • Number of events 18 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.9% 9/312 • Number of events 9 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders GENERALISED OEDEMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders HYPOTHERMIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders INFUSION SITE HAEMATOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders INJECTION SITE HAEMATOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders INJECTION SITE HAEMORRHAGE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders MALAISE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders MEDICAL DEVICE COMPLICATION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders MUCOSAL HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders NON-CARDIAC CHEST PAIN	2.3% 7/302 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.6% 8/312 • Number of events 12 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications FOREARM FRACTURE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders OEDEMA	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders OEDEMA PERIPHERAL	5.0% 15/302 • Number of events 16 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	4.2% 13/312 • Number of events 18 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders PELVIC MASS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders PYREXIA	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders ULCER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders VESSEL PUNCTURE SITE HAEMATOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders VESSEL PUNCTURE SITE HAEMORRHAGE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders CHOLECYSTITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders CHOLELITHIASIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders HEPATIC CIRRHOSIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders HEPATIC CONGESTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders HEPATOMEGALY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders HYPERBILIRUBINAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Hepatobiliary disorders LIVER DISORDER	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Immune system disorders DRUG HYPERSENSITIVITY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Immune system disorders SEASONAL ALLERGY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ACUTE SINUSITIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ASYMPTOMATIC BACTERIURIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations BACTERAEMIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations BRONCHITIS	2.6% 8/302 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.2% 7/312 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations CANDIDIASIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations CATHETER SITE INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations CELLULITIS	1.7% 5/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations CLOSTRIDIAL INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations CYSTITIS KLEBSIELLA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations DEVICE RELATED INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations DIVERTICULITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations EAR INFECTION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ENDOCARDITIS ENTEROCOCCAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ENTEROCOCCAL BACTERAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations GASTROENTERITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations HERPES ZOSTER	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations INCISION SITE ABSCESS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations INFECTED BITES	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations INFLUENZA	2.3% 7/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations INTERVERTEBRAL DISCITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations LOCALISED INFECTION	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations NASOPHARYNGITIS	2.3% 7/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ONYCHOMYCOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ORAL CANDIDIASIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ORAL HERPES	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations OTITIS MEDIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations OTITIS MEDIA ACUTE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations PERITONITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations PHARYNGITIS	0.33% 1/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations PNEUMONIA	5.3% 16/302 • Number of events 18 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	4.2% 13/312 • Number of events 14 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations RESPIRATORY TRACT INFECTION VIRAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations RHINITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations RHINOVIRUS INFECTION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations SEPSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations SEPTIC SHOCK	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations SINUSITIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations STAPHYLOCOCCAL BACTERAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations STAPHYLOCOCCAL SEPSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations TOOTH INFECTION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	3.6% 11/302 • Number of events 14 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.9% 9/312 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations URINARY TRACT INFECTION	7.6% 23/302 • Number of events 32 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	6.1% 19/312 • Number of events 19 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations URINARY TRACT INFECTION BACTERIAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations URINARY TRACT INFECTION ENTEROCOCCAL	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations UROSEPSIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations VIRAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations VIRAL INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications AGITATION POSTOPERATIVE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications ANAEMIA POSTOPERATIVE	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications ANIMAL BITE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications ANKLE FRACTURE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications CARDIAC PROCEDURE COMPLICATION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications CATHETER SITE HAEMATOMA	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications CERVICAL VERTEBRAL FRACTURE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications CONTUSION	1.7% 5/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications CRANIOCEREBRAL INJURY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications EAR ABRASION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications EAR INJURY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications ENDOTRACHEAL INTUBATION COMPLICATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications EXCORIATION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications FACE INJURY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications FALL	6.6% 20/302 • Number of events 21 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	6.7% 21/312 • Number of events 26 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications FEMUR FRACTURE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications FOOT FRACTURE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications LIGAMENT SPRAIN	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications LIMB INJURY	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications MULTIPLE FRACTURES	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications MUSCLE STRAIN	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications OPEN WOUND	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications PERIORBITAL HAEMATOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications POST PROCEDURAL DIARRHOEA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications POST PROCEDURAL HAEMATURIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications POST PROCEDURAL HYPOTHYROIDISM	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications POST-TRAUMATIC PAIN	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications PROCEDURAL COMPLICATION	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications PROCEDURAL DIZZINESS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications PROCEDURAL HAEMORRHAGE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications PROCEDURAL HEADACHE	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications PROCEDURAL HYPOTENSION	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications PROCEDURAL NAUSEA	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications RIB FRACTURE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications SKELETAL INJURY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications SKIN WOUND	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications SUBCUTANEOUS HAEMATOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications THERMAL BURN	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications TOXICITY TO VARIOUS AGENTS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications TRAUMATIC HAEMATOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications TRAUMATIC HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications TRAUMATIC INTRACRANIAL HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications TRAUMATIC LUNG INJURY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications URETHRAL INJURY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications URINARY RETENTION POSTOPERATIVE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications VASCULAR GRAFT OCCLUSION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications WRIST FRACTURE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations AMYLASE INCREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations ANTIBIOTIC RESISTANT STAPHYLOCOCCUS TEST POSITIVE	0.66% 2/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC	0.66% 2/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	2.0% 6/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations BLOOD CREATINE MB PHOSPHOKINASE INCREASED	2.6% 8/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.9% 9/312 • Number of events 12 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations BLOOD CREATININE INCREASED	3.0% 9/302 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations BLOOD GLUCOSE INCREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations BLOOD POTASSIUM INCREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations BLOOD PRESSURE DECREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations BLOOD THYROID STIMULATING HORMONE INCREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations BLOOD UREA INCREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations BRAIN NATRIURETIC PEPTIDE INCREASED	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations CARCINOEMBRYONIC ANTIGEN INCREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations CARDIAC ENZYMES INCREASED	0.66% 2/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations CARDIAC INDEX DECREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations CARDIAC OUTPUT DECREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations CLOSTRIDIUM TEST POSITIVE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations DRUG LEVEL ABOVE THERAPEUTIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations EJECTION FRACTION DECREASED	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations ELECTROCARDIOGRAM ABNORMAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations ELECTROCARDIOGRAM CHANGE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations ELECTROCARDIOGRAM QT PROLONGED	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations FIBRIN D DIMER INCREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations HAEMATOLOGY TEST ABNORMAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations HAEMOGLOBIN DECREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations HEART RATE INCREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations HELICOBACTER TEST POSITIVE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations HEPATIC ENZYME INCREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations LIPASE INCREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations LIVER FUNCTION TEST ABNORMAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations OCCULT BLOOD POSITIVE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations OXYGEN CONSUMPTION DECREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations OXYGEN SATURATION DECREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations PLATELET COUNT DECREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations PROTHROMBIN TIME PROLONGED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations TRANSAMINASES INCREASED	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations TROPONIN I INCREASED	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations TROPONIN INCREASED	1.7% 5/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.5% 11/312 • Number of events 11 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations ULTRASOUND ABDOMEN NORMAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations WEIGHT DECREASED	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations WEIGHT INCREASED	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations WHITE BLOOD CELL COUNT INCREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders ACIDOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders CACHEXIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders DECREASED APPETITE	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders DEHYDRATION	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.6% 8/312 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders DYSLIPIDAEMIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders FAILURE TO THRIVE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders FLUID OVERLOAD	2.6% 8/302 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders FLUID RETENTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders GOUT	3.6% 11/302 • Number of events 14 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.8% 12/312 • Number of events 16 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPERAMMONAEMIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPERCALCAEMIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPERKALAEMIA	5.6% 17/302 • Number of events 18 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.2% 10/312 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPERNATRAEMIA	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPERVOLAEMIA	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPOCALCAEMIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPOCHLORAEMIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPOKALAEMIA	3.3% 10/302 • Number of events 13 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.8% 12/312 • Number of events 13 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPOMAGNESAEMIA	1.7% 5/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPONATRAEMIA	1.7% 5/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	4.5% 14/312 • Number of events 16 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders HYPOVOLAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders LACTIC ACIDOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders LACTOSE INTOLERANCE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders MALNUTRITION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders METABOLIC ALKALOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders TYPE 2 DIABETES MELLITUS	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders ARTHRALGIA	2.0% 6/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders ARTHRITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders BACK PAIN	3.3% 10/302 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.2% 7/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders BURSITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders FLANK PAIN	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders GOUTY ARTHRITIS	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders JOINT EFFUSION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders LIMB DISCOMFORT	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders MOBILITY DECREASED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders MUSCLE HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	2.3% 7/302 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders MYALGIA	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders MYOSITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders NECK MASS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders NECK PAIN	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	3.6% 11/302 • Number of events 11 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.2% 10/312 • Number of events 10 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders RENAL OSTEODYSTROPHY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders TENDONITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADRENAL ADENOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-CELL LYMPHOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BOWEN'S DISEASE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CANCER PAIN	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MYELODYSPLASTIC SYNDROME	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PARAPROTEINAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CELL CARCINOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SEBORRHOEIC KERATOSIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN CANCER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders ALTERED STATE OF CONSCIOUSNESS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders AMNESIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders BALANCE DISORDER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders CARPAL TUNNEL SYNDROME	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders COGNITIVE DISORDER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders DEMENTIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders DEMENTIA ALZHEIMER'S TYPE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders DIABETIC NEUROPATHY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders DIZZINESS	6.0% 18/302 • Number of events 24 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	4.8% 15/312 • Number of events 18 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders DIZZINESS POSTURAL	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders DYSARTHRIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders ENCEPHALOPATHY	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders ESSENTIAL TREMOR	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders GUILLAIN-BARRE SYNDROME	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders HEADACHE	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.6% 5/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders HYPOAESTHESIA	1.3% 4/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders LACUNAR INFARCTION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders LOSS OF CONSCIOUSNESS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders LUMBAR RADICULOPATHY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders METABOLIC ENCEPHALOPATHY	0.66% 2/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders MIGRAINE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders MYOCLONUS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders PARAESTHESIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders PARKINSON'S DISEASE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders PARKINSONISM	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders PARTIAL SEIZURES	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders PHANTOM PAIN	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders PRESYNCOPE	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.2% 7/312 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders RESTLESS LEGS SYNDROME	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders SCIATICA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders SOMNOLENCE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders SYNCOPE	2.6% 8/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.2% 10/312 • Number of events 13 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders TREMOR	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders VASCULAR DEMENTIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders ANXIETY	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders CONFUSIONAL STATE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders DELIRIUM	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders DEPRESSION	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders HALLUCINATION	0.33% 1/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders INSOMNIA	2.0% 6/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders MAJOR DEPRESSION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders MENTAL DISORDER	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders MENTAL STATUS CHANGES	2.6% 8/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders PANIC ATTACK	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Psychiatric disorders STRESS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders BLADDER SPASM	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders CYSTITIS HAEMORRHAGIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders DYSURIA	1.7% 5/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders HAEMATURIA	4.3% 13/302 • Number of events 13 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.2% 7/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders NEPHROPATHY TOXIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders PYURIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders RENAL CYST	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders RENAL FAILURE	2.6% 8/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.2% 7/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders RENAL FAILURE ACUTE	8.9% 27/302 • Number of events 30 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	9.3% 29/312 • Number of events 40 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders RENAL FAILURE CHRONIC	3.0% 9/302 • Number of events 9 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders RENAL IMPAIRMENT	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders RENAL INJURY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders RENAL MASS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders RENAL TUBULAR NECROSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders URINARY RETENTION	2.6% 8/302 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Reproductive system and breast disorders ACQUIRED PHIMOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Reproductive system and breast disorders BREAST INFLAMMATION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Reproductive system and breast disorders BREAST MASS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Reproductive system and breast disorders BREAST PAIN	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Reproductive system and breast disorders BREAST TENDERNESS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Reproductive system and breast disorders GYNAECOMASTIA	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders ASTHMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders ATELECTASIS	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	3.0% 9/302 • Number of events 9 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 14 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders COUGH	1.7% 5/302 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.5% 11/312 • Number of events 11 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders DYSPHONIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders DYSPNOEA	7.6% 23/302 • Number of events 23 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	8.7% 27/312 • Number of events 39 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders DYSPNOEA PAROXYSMAL NOCTURNAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders EMPHYSEMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders EPISTAXIS	4.3% 13/302 • Number of events 14 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.5% 11/312 • Number of events 11 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders HICCUPS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders HYPERCAPNIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders LUNG INFILTRATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders ORTHOPNOEA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PAINFUL RESPIRATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	6.3% 19/302 • Number of events 21 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	4.2% 13/312 • Number of events 13 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PLEURITIC PAIN	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PULMONARY CONGESTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PULMONARY HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	1.3% 4/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PULMONARY MASS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.99% 3/302 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders WHEEZING	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders ACTINIC KERATOSIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders ALOPECIA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders ANGIOEDEMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders CUTIS LAXA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders DECUBITUS ULCER	1.7% 5/302 • Number of events 6 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders DERMATITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders DIABETIC FOOT	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders DRUG ERUPTION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders ECCHYMOSIS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders ECZEMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders INCREASED TENDENCY TO BRUISE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders INGROWING NAIL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders PETECHIAE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders PRURITUS ALLERGIC	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders RASH	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.96% 3/312 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders SKIN HAEMORRHAGE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders SKIN LESION	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders SKIN ULCER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.3% 4/312 • Number of events 5 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders STASIS DERMATITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders URTICARIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures CARDIAC PACEMAKER BATTERY REPLACEMENT	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures MEDICAL DEVICE BATTERY REPLACEMENT	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures RENAL STONE REMOVAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures ROUTINE HEALTH MAINTENANCE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders AORTIC ANEURYSM	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders AORTIC STENOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders ARTERIOVENOUS FISTULA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders DEEP VEIN THROMBOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders FEMORAL ARTERY OCCLUSION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders HAEMATOMA	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders HAEMORRHAGE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders HYPERTENSION	0.99% 3/302 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 6/312 • Number of events 7 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders HYPOTENSION	11.6% 35/302 • Number of events 38 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	9.3% 29/312 • Number of events 33 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders INTERMITTENT CLAUDICATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders ORTHOSTATIC HYPERTENSION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders PERIPHERAL ISCHAEMIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders SUBCLAVIAN ARTERY OCCLUSION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders THROMBOPHLEBITIS SUPERFICIAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders ACUTE LEFT VENTRICULAR FAILURE	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders CHRONIC LEFT VENTRICULAR FAILURE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Ear and labyrinth disorders DEAFNESS BILATERAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Ear and labyrinth disorders EAR DISCOMFORT	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Ear and labyrinth disorders TYMPANIC MEMBRANE PERFORATION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Endocrine disorders ADRENAL INSUFFICIENCY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Endocrine disorders EUTHYROID SICK SYNDROME	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Endocrine disorders HYPERPARATHYROIDISM SECONDARY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders CHALAZION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders EPISCLERITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Eye disorders MYOPIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders ABDOMINAL HERNIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders CHANGE OF BOWEL HABIT	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders COLONIC POLYP	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DIARRHOEA	4.3% 13/302 • Number of events 14 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	3.2% 10/312 • Number of events 13 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DIVERTICULUM OESOPHAGEAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders DYSPEPSIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders FAECALOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders FAECES DISCOLOURED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders FOOD POISONING	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders GASTRITIS EROSIVE	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders LARGE INTESTINAL ULCER	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders LOWER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders OESOPHAGEAL ULCER	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Gastrointestinal disorders PANCREATIC CYST	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders DEVICE OCCLUSION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders EARLY SATIETY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders PAIN	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ACUTE TONSILLITIS	0.33% 1/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations CYSTITIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.64% 2/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations ESCHERICHIA INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations OTITIS EXTERNA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations RESPIRATORY SYNCYTIAL VIRUS INFECTION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Infections and infestations WOUND INFECTION BACTERIAL	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications BACK INJURY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications CORNEAL ABRASION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications FACIAL BONES FRACTURE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications POST LUMBAR PUNCTURE SYNDROME	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Injury, poisoning and procedural complications SKIN INJURY	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations BLOOD SODIUM ABNORMAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations CARDIAC PACEMAKER EVALUATION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations POSITRON EMISSION TOMOGRAM ABNORMAL	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations SERUM FERRITIN DECREASED	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Investigations SIMPLEX VIRUS TEST POSITIVE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders IRON DEFICIENCY	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Metabolism and nutrition disorders VITAMIN B12 DEFICIENCY	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders GROIN PAIN	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders PLANTAR FASCIITIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders SPINAL DISORDER	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders TORTICOLLIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders TRIGGER FINGER	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIPOMA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN PAPILLOMA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders CENTRAL NERVOUS SYSTEM LESION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders HYPERSOMNIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders NEURALGIA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Nervous system disorders NEUROLOGICAL SYMPTOM	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders POLLAKIURIA	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Reproductive system and breast disorders GENITAL LESION	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders IDIOPATHIC PULMONARY FIBROSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders RESTRICTIVE PULMONARY DISEASE	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Respiratory, thoracic and mediastinal disorders SLEEP APNOEA SYNDROME	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders BLOOD BLISTER	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders ERYTHEMA MULTIFORME	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders HYPERKERATOSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders RURITUS	0.66% 2/302 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Skin and subcutaneous tissue disorders RASH GENERALISED	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders EXTREMITY NECROSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders HYPERTENSIVE CRISIS	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders LABILE HYPERTENSION	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders LYMPHOEDEMA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures ASD Closure Following Transseptal Catheterization	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.2% 2/162 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures Mitral Valve Reintervention	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.5% 4/162 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures Unplanned Other Cardiac Surgery or Intervention	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	4.3% 7/162 • Number of events 8 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders Other Device Related Event	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.9% 3/162 • Number of events 3 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
General disorders Single Leaflet Device Attachment	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.62% 1/162 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders Ischemic Stroke	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.62% 1/162 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders Cardiac Readmission	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	11.1% 18/162 • Number of events 20 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders Heart Failure Readmission	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	23.5% 38/162 • Number of events 55 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Cardiac disorders Non Cardiac Readmission	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	26.5% 43/162 • Number of events 76 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Renal and urinary disorders New Requirement for Dialysis	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.5% 4/162 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Surgical and medical procedures Mitral Leaflet Injury	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.62% 1/162 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders Bleeding at Access Site	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	2.5% 4/162 • Number of events 4 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders GU Bleed	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.62% 1/162 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders Life threatening Bleeding	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.2% 2/162 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders Major Bleeding Event	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.2% 2/162 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders Major Vascular Complications	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.62% 1/162 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Vascular disorders Other Bleed	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	1.2% 2/162 • Number of events 2 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Musculoskeletal and connective tissue disorders HAEMARTHROSIS	0.33% 1/302 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/312 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.00% 0/302 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.32% 1/312 • Number of events 1 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group	0.00% 0/162 • COAPT IDE - 60 Months and COAPT CAS - 12 months TVT Registry Mitral module does not collect the serious adverse events for COAPT CAS group. Only AE table is being populated for the COAPT CAS group

Additional Information

Sripad Bellary

Abbott

Phone: 4088458114

Email: sripad.bellary@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place