Trial Outcomes & Findings for The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System (NCT NCT02787408)
NCT ID: NCT02787408
Last Updated: 2022-10-25
Results Overview
The primary endpoint for the study will assess the all-cause mortality of the as treated cohort at 30 days compared to a literature derived Performance Goal based on high-risk surgical outcomes for tricuspid repair/replacement. Due to the early termination of the study, the desired statistical power was not attained and thus this comparison analysis was not performed. All-cause mortality is presented below as a number of deaths and percentage of patients only.
COMPLETED
NA
25 participants
At 30 days.
2022-10-25
Participant Flow
Participant milestones
| Measure |
EW Tricuspid Transcatheter Repair System
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
EW Tricuspid Transcatheter Repair System
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
|
|---|---|
|
Overall Study
Death
|
16
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Non-implanted patient exited post 6 month follow-up visit per protocol
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EW Tricuspid Transcatheter Repair System
n=25 Participants
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
|
|---|---|
|
Age, Continuous
|
74.6 years
STANDARD_DEVIATION 7.06 • n=25 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=25 Participants
|
|
Region of Enrollment
Greece
|
4 Participants
n=25 Participants
|
|
Region of Enrollment
Canada
|
11 Participants
n=25 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=25 Participants
|
|
Region of Enrollment
Switzerland
|
1 Participants
n=25 Participants
|
|
Region of Enrollment
Germany
|
8 Participants
n=25 Participants
|
|
Body Mass Index (BMI)
|
26.2 kg/m^2
STANDARD_DEVIATION 4.74 • n=25 Participants
|
|
New York Heart Association Class (NYHA)
Class I
|
0 Participants
n=25 Participants
|
|
New York Heart Association Class (NYHA)
Class II
|
6 Participants
n=25 Participants
|
|
New York Heart Association Class (NYHA)
Class III
|
14 Participants
n=25 Participants
|
|
New York Heart Association Class (NYHA)
Class IV
|
5 Participants
n=25 Participants
|
|
The European System for Cardiac Operative Risk Evaluation: EuroScore II
|
11.5 Percentage of surgical risk
STANDARD_DEVIATION 7.65 • n=25 Participants
|
|
History of Heart Failure
|
13 Participants
n=25 Participants
|
|
Hospitalization for Heart Failure prior 6 months
|
13 Participants
n=25 Participants
|
|
Diabetes
No
|
22 Participants
n=25 Participants
|
|
Diabetes
Type 1
|
0 Participants
n=25 Participants
|
|
Diabetes
Type II ( Insulin treated)
|
1 Participants
n=25 Participants
|
|
Diabetes
Type II ( Non-Insulin treated)
|
2 Participants
n=25 Participants
|
|
Cancer
|
3 Participants
n=25 Participants
|
|
Carotid Artery Disease
|
2 Participants
n=25 Participants
|
|
Coagulopathy
|
0 Participants
n=25 Participants
|
|
Coronary Artery Disease
|
10 Participants
n=25 Participants
|
|
Hyperlipidemia
|
8 Participants
n=25 Participants
|
|
Hypertension
|
14 Participants
n=25 Participants
|
|
Liver Disease
|
3 Participants
n=25 Participants
|
|
Myocardial Infarction (MI)
|
0 Participants
n=25 Participants
|
|
Pacemaker/Implantable cardioverter-defibrillator (ICD)
|
4 Participants
n=25 Participants
|
|
Peripheral Vascular Disease
|
3 Participants
n=25 Participants
|
|
Prior Percutaneous Coronary Intervention (PCI)
|
5 Participants
n=25 Participants
|
|
Prior Coronary Artery Bypass Graft (CABG)
|
5 Participants
n=25 Participants
|
|
Prior valve implant
|
13 Participants
n=25 Participants
|
|
Pulmonary Disease
|
2 Participants
n=25 Participants
|
|
Pulmonary Hypertension
|
12 Participants
n=25 Participants
|
|
Stroke
|
5 Participants
n=25 Participants
|
|
Transient Ischemic Attack (TIA)
|
0 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: At 30 days.Population: As Treated (AT) Cohort: All subjects who are enrolled and undergo the study procedure (chest incision)
The primary endpoint for the study will assess the all-cause mortality of the as treated cohort at 30 days compared to a literature derived Performance Goal based on high-risk surgical outcomes for tricuspid repair/replacement. Due to the early termination of the study, the desired statistical power was not attained and thus this comparison analysis was not performed. All-cause mortality is presented below as a number of deaths and percentage of patients only.
Outcome measures
| Measure |
EW Tricuspid Transcatheter Repair System
n=25 Participants
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
|
|---|---|
|
All-cause Mortality
|
2 Participants
|
SECONDARY outcome
Timeframe: Implant ProcedurePopulation: As Treated (AT) Cohort: all subjects who are enrolled and undergo the study procedure (chest incision)
Alive, with * Successful access, delivery and removal of the delivery systems, and * Deployment and correct positioning of the intended device, and * No need for additional emergency surgery or re-intervention related to the device or access procedure
Outcome measures
| Measure |
EW Tricuspid Transcatheter Repair System
n=25 Participants
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
|
|---|---|
|
Technical Success
|
22 Participants
|
SECONDARY outcome
Timeframe: At 1 month, 6 months, 1, 2, and 3 yearsPopulation: Implanted Cohort: all subjects who undergo the study procedure (chest incision), receive and retain the investigational device upon leaving the procedure room \*Count of Participants reflects those subjects who had been implanted, and who had all components of device success
Alive, with * Original intended device in place, and * No additional surgical or interventional procedures related to the device, and * Tricuspid Regurgitation (TR) reduction compared to baseline and Tricuspid Valve (TV) gradient ≤ 5 mmHg
Outcome measures
| Measure |
EW Tricuspid Transcatheter Repair System
n=21 Participants
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
|
|---|---|
|
Device Success
30 days
|
4 Participants
|
|
Device Success
6 months
|
3 Participants
|
|
Device Success
1 year
|
3 Participants
|
|
Device Success
2 years
|
2 Participants
|
|
Device Success
3 years
|
0 Participants
|
SECONDARY outcome
Timeframe: At 1 monthPopulation: Implanted Cohort: all subjects who undergo the study procedure (chest incision), receive and retain the investigational device upon leaving the procedure room Denominator reflects those patients who experienced device success and no device or procedure related SAEs
Device Success, and None of the following device or procedure related Serious Adverse Events (SAE): * Life threatening bleeding * Major vascular or cardiac structural complications requiring intervention * Pericardial effusion requiring drainage or surgery (includes tamponade) * Stage 2 or 3 acute kidney injury (includes new dialysis). * Severe heart failure or hypotension requiring Intravenous (IV) inotrope, ultrafiltration or mechanical circulatory support * Prolonged intubation \> 48 hours
Outcome measures
| Measure |
EW Tricuspid Transcatheter Repair System
n=21 Participants
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
|
|---|---|
|
Procedural Success
|
4 Participants
|
SECONDARY outcome
Timeframe: At 1 month, 6 months, 1, 2 and 3 yearsPopulation: Kaplan Meier Analysis on Subjects Experiencing Heart Failure Rehospitalization Events
Re-hospitalization rates for the underlying condition (heart failure)
Outcome measures
| Measure |
EW Tricuspid Transcatheter Repair System
n=25 Participants
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
|
|---|---|
|
Clinical Outcomes [Heart Failure Re-Hospitalization Rates]
KM Estimate at 1 year
|
85.6 Percentage of participants
Interval 61.2 to 95.2
|
|
Clinical Outcomes [Heart Failure Re-Hospitalization Rates]
KM Estimate at 30 days
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Clinical Outcomes [Heart Failure Re-Hospitalization Rates]
KM Estimate at 6 months
|
91.3 Percentage of participants
Interval 69.5 to 97.8
|
|
Clinical Outcomes [Heart Failure Re-Hospitalization Rates]
KM Estimate at 2 years
|
72.9 Percentage of participants
Interval 45.7 to 88.0
|
|
Clinical Outcomes [Heart Failure Re-Hospitalization Rates]
KM Estimate at 3 years
|
72.9 Percentage of participants
Interval 45.7 to 88.0
|
SECONDARY outcome
Timeframe: At 1 month, 6 months, 1, 2 and 3 yearsPopulation: Kaplan Meier Analysis on Subjects Experiencing Re-intervention for Tricuspid Reintervention
Re-intervention rates for the underlying condition (tricuspid regurgitation)
Outcome measures
| Measure |
EW Tricuspid Transcatheter Repair System
n=25 Participants
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
|
|---|---|
|
Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]
KM Estimate at 30 days
|
96.0 Percentage of participants
Interval 74.8 to 99.4
|
|
Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]
KM Estimate at 6 months
|
96.0 Percentage of participants
Interval 74.8 to 99.4
|
|
Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]
KM Estimate at 1 year
|
96.0 Percentage of participants
Interval 74.8 to 99.4
|
|
Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]
KM Estimate at 2 years
|
96.0 Percentage of participants
Interval 74.8 to 99.4
|
|
Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]
KM Estimate at 3 years
|
96.0 Percentage of participants
Interval 74.8 to 99.4
|
SECONDARY outcome
Timeframe: At 1 month, 6 months, 1, 2 and 3 yearsPopulation: Implanted Cohort: All subjects who underwent the study procedure (chest incision), received and retained the investigational device upon leaving the procedure room \*Paired Analysis Number of subjects analyzed are those with available paired data at the follow-up
Change in peripheral edema as assessed by subject weight loss (kilograms) compared to baseline
Outcome measures
| Measure |
EW Tricuspid Transcatheter Repair System
n=22 Participants
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
|
|---|---|
|
Clinical Outcomes [Changes in Peripheral Edema]
Baseline 1 month
|
75.1 kg
Standard Deviation 14.94
|
|
Clinical Outcomes [Changes in Peripheral Edema]
1 month
|
73.1 kg
Standard Deviation 13.34
|
|
Clinical Outcomes [Changes in Peripheral Edema]
Baseline 6 months
|
72.7 kg
Standard Deviation 13.25
|
|
Clinical Outcomes [Changes in Peripheral Edema]
6 months
|
70.2 kg
Standard Deviation 11.99
|
|
Clinical Outcomes [Changes in Peripheral Edema]
Baseline 1 year
|
74.3 kg
Standard Deviation 13.17
|
|
Clinical Outcomes [Changes in Peripheral Edema]
1 year
|
71.0 kg
Standard Deviation 10.87
|
|
Clinical Outcomes [Changes in Peripheral Edema]
Baseline 2 years
|
76.5 kg
Standard Deviation 13.13
|
|
Clinical Outcomes [Changes in Peripheral Edema]
2 years
|
71.9 kg
Standard Deviation 8.80
|
|
Clinical Outcomes [Changes in Peripheral Edema]
Baseline 3 years
|
81.3 kg
Standard Deviation 13.93
|
|
Clinical Outcomes [Changes in Peripheral Edema]
3 years
|
71.8 kg
Standard Deviation 11.56
|
SECONDARY outcome
Timeframe: At 1 month, 6 months, 1, 2 and 3 yearsPopulation: Implanted Cohort: All subjects who undergo the study procedure (chest incision), receive and retain the investigational device upon leaving the procedure room \*Paired Analysis Number of subjects analyzed are those with available paired data at the follow-up
Change in New York Heart Association (NYHA) Class compared to baseline Measure Description: Measure Description: NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.
Outcome measures
| Measure |
EW Tricuspid Transcatheter Repair System
n=22 Participants
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
|
|---|---|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
Baseline · Class I
|
0 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
Baseline · Class II
|
5 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
Baseline · Class III
|
12 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
Baseline · Class IV
|
5 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
30 Days · Class I
|
2 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
30 Days · Class II
|
12 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
30 Days · Class III
|
8 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
30 Days · Class IV
|
0 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
6 months · Class I
|
6 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
6 months · Class II
|
8 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
6 months · Class III
|
4 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
6 months · Class IV
|
1 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
1 year · Class I
|
5 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
1 year · Class II
|
7 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
1 year · Class III
|
5 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
1 year · Class IV
|
0 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
2 years · Class I
|
5 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
2 years · Class II
|
5 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
2 years · Class III
|
0 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
2 years · Class IV
|
1 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
3 years · Class I
|
3 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
3 years · Class II
|
0 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
3 years · Class III
|
1 Participants
|
|
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
3 years · Class IV
|
0 Participants
|
SECONDARY outcome
Timeframe: At 1 month, 6 months, 1, 2 and 3 yearsPopulation: Implanted Cohort: All subjects who undergo the study procedure (chest incision), receive and retain the investigational device upon leaving the procedure room \*Paired Analysis Number of subjects analyzed are those with available paired data at the follow-up
Change in 6 minute walk test distance (meters) compared to baseline
Outcome measures
| Measure |
EW Tricuspid Transcatheter Repair System
n=22 Participants
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
|
|---|---|
|
Clinical Outcomes [Change in 6 Minute Walk Test Distance]
Baseline 1 Month
|
328.7 Meters
Standard Deviation 83.88
|
|
Clinical Outcomes [Change in 6 Minute Walk Test Distance]
1 month
|
333.2 Meters
Standard Deviation 107.90
|
|
Clinical Outcomes [Change in 6 Minute Walk Test Distance]
Baseline 6 months
|
329.9 Meters
Standard Deviation 72.49
|
|
Clinical Outcomes [Change in 6 Minute Walk Test Distance]
6 months
|
351.6 Meters
Standard Deviation 77.04
|
|
Clinical Outcomes [Change in 6 Minute Walk Test Distance]
Baseline 1 year
|
320.9 Meters
Standard Deviation 76.94
|
|
Clinical Outcomes [Change in 6 Minute Walk Test Distance]
1 year
|
353.0 Meters
Standard Deviation 110.93
|
|
Clinical Outcomes [Change in 6 Minute Walk Test Distance]
Baseline 2 years
|
322.0 Meters
Standard Deviation 92.17
|
|
Clinical Outcomes [Change in 6 Minute Walk Test Distance]
2 years
|
262.0 Meters
Standard Deviation 115.85
|
|
Clinical Outcomes [Change in 6 Minute Walk Test Distance]
Baseline 3 years
|
339.0 Meters
Standard Deviation 0
|
|
Clinical Outcomes [Change in 6 Minute Walk Test Distance]
3 years
|
180.0 Meters
Standard Deviation 0
|
SECONDARY outcome
Timeframe: At 1 month, 6 months, 1, 2 and 3 yearsPopulation: Implanted Cohort: All subjects who undergo the study procedure (chest incision), receive and retain the investigational device upon leaving the procedure room \*Paired Analysis Number of subjects analyzed are those with available paired data at the follow-up
Change in Quality of Life as assessed by the Short Form (SF)-12 questionnaire compared to baseline The SF-12 is a short survey with 12 questions that results in two scales of mental and physical functioning and overall health related quality of life. The SF-12 Score is scaled from 0-100, with higher scores indicating better physical and mental health functioning.
Outcome measures
| Measure |
EW Tricuspid Transcatheter Repair System
n=22 Participants
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
|
|---|---|
|
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
Baseline 1 month
|
36.3 score on a scale
Standard Deviation 11.14
|
|
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
1 month
|
39.4 score on a scale
Standard Deviation 9.25
|
|
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
Baseline 6 months
|
37.7 score on a scale
Standard Deviation 11.24
|
|
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
6 months
|
40.3 score on a scale
Standard Deviation 9.75
|
|
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
Baseline 1 year
|
35.6 score on a scale
Standard Deviation 11.03
|
|
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
1 year
|
42.7 score on a scale
Standard Deviation 12.08
|
|
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
Baseline 2 years
|
41.0 score on a scale
Standard Deviation 10.32
|
|
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
2 years
|
44.3 score on a scale
Standard Deviation 10.06
|
|
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
Baseline 3 years
|
40.8 score on a scale
Standard Deviation 11.38
|
|
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
3 years
|
43.4 score on a scale
Standard Deviation 7.41
|
SECONDARY outcome
Timeframe: At 1 month, 6 months, 1, 2 and 3 yearsPopulation: Implanted Cohort: All subjects who undergo the study procedure (chest incision), receive and retain the investigational device upon leaving the procedure room \*Paired Analysis Number of subjects analyzed are those with available paired data at the follow-up
Change in Quality of Life as assessed by the KCCQ questionnaire compared to baseline The KCCQ is a 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. The KCCQ scale is 0-100. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.
Outcome measures
| Measure |
EW Tricuspid Transcatheter Repair System
n=22 Participants
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
|
|---|---|
|
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
Baseline 1 month
|
48.7 score on a scale
Standard Deviation 31.23
|
|
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
1 month
|
59.6 score on a scale
Standard Deviation 27.68
|
|
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
Baseline 6 months
|
49.7 score on a scale
Standard Deviation 33.11
|
|
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
6 months
|
71.9 score on a scale
Standard Deviation 28.19
|
|
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
Baseline 1 year
|
46.2 score on a scale
Standard Deviation 34.48
|
|
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
1 year
|
70.8 score on a scale
Standard Deviation 26.25
|
|
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
Baseline 2 years
|
60.9 score on a scale
Standard Deviation 34.12
|
|
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
2 years
|
76.0 score on a scale
Standard Deviation 25.48
|
|
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
Baseline 3 years
|
56.4 score on a scale
Standard Deviation 38.97
|
|
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
3 years
|
75.9 score on a scale
Standard Deviation 22.08
|
Adverse Events
EW Tricuspid Transcatheter Repair System
Serious adverse events
| Measure |
EW Tricuspid Transcatheter Repair System
n=25 participants at risk
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
As Treated (AT) Cohort: all subjects who are enrolled and undergo the study procedure (chest incision)
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
36.0%
9/25 • Number of events 14 • 3 years
|
|
Cardiac disorders
Cardiac arrest
|
16.0%
4/25 • Number of events 4 • 3 years
|
|
Cardiac disorders
Cardiogenic shock
|
12.0%
3/25 • Number of events 3 • 3 years
|
|
Cardiac disorders
Acute myocardial infarction
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Cardiac disorders
Ventricular tachycardia
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Cardiac disorders
Arrhythmia
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Cardiac disorders
Bradycardia
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Cardiac disorders
Cardiac cirrhosis
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Cardiac disorders
Cardiac tamponade
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Infections and infestations
Sepsis
|
12.0%
3/25 • Number of events 3 • 3 years
|
|
Infections and infestations
Endocarditis
|
8.0%
2/25 • Number of events 3 • 3 years
|
|
Infections and infestations
Septic shock
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Infections and infestations
Intervertebral discitis
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
12.0%
3/25 • Number of events 3 • 3 years
|
|
Injury, poisoning and procedural complications
Vascular access site hematoma
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Heart injury
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Hematoma
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Ventricle rupture
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Vascular disorders
Shock haemorrhagic
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Vascular disorders
Anaemia
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Vascular disorders
Epistaxis
|
4.0%
1/25 • Number of events 2 • 3 years
|
|
Vascular disorders
Gastrointestinal haemorrhage
|
4.0%
1/25 • Number of events 2 • 3 years
|
|
Vascular disorders
Intra-abdominal haematoma
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Vascular disorders
Peripheral artery haematoma
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Vascular disorders
Pulmonary embolism
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Vascular disorders
Rectal haemorrhage
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Vascular disorders
Syncope
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Vascular disorders
Vena cava thrombosis
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Renal failure
|
12.0%
3/25 • Number of events 3 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Renal and urinary disorders
Nephrogenic anaemia
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Nervous system disorders
Cerebrovascular accident
|
12.0%
3/25 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Intestinal ischemia
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Immune system disorders
Amyloidosis
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Product Issues
Device physical property issue
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Surgical and medical procedures
Hip arthroplasty
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Ileus
|
4.0%
1/25 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.0%
2/25 • Number of events 2 • 3 years
|
Other adverse events
| Measure |
EW Tricuspid Transcatheter Repair System
n=25 participants at risk
Edwards (EW) Tricuspid Transcatheter Repair System
EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System
As Treated (AT) Cohort: all subjects who are enrolled and undergo the study procedure (chest incision)
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
48.0%
12/25 • Number of events 17 • 3 years
|
|
Cardiac disorders
Cardiac arrest
|
16.0%
4/25 • Number of events 4 • 3 years
|
|
Cardiac disorders
Cardiogenic shock
|
12.0%
3/25 • Number of events 3 • 3 years
|
|
Cardiac disorders
Acute myocardial infarction
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Cardiac disorders
Bradycardia
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Cardiac disorders
Ventricular tachycardia
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
12.0%
3/25 • Number of events 3 • 3 years
|
|
Injury, poisoning and procedural complications
Haematoma muscle
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Vascular access site hematoma
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Renal and urinary disorders
Renal failure
|
28.0%
7/25 • Number of events 8 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
12.0%
3/25 • Number of events 3 • 3 years
|
|
Vascular disorders
Device related thrombosis
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Vascular disorders
Epistaxis
|
8.0%
2/25 • Number of events 3 • 3 years
|
|
Vascular disorders
Gastrointestinal haemorrhage
|
8.0%
2/25 • Number of events 3 • 3 years
|
|
Vascular disorders
Shock haemorrhagic
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Infections and infestations
Sepsis
|
12.0%
3/25 • Number of events 3 • 3 years
|
|
Infections and infestations
Endocarditis
|
8.0%
2/25 • Number of events 3 • 3 years
|
|
Infections and infestations
Septic shock
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
8.0%
2/25 • Number of events 3 • 3 years
|
|
Nervous system disorders
Cerebrovascular accident
|
16.0%
4/25 • Number of events 4 • 3 years
|
|
Nervous system disorders
Nerve injury
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
8.0%
2/25 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.0%
2/25 • Number of events 2 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place