Trial Outcomes & Findings for Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement (NCT NCT01531374)

Last Updated: 2022-10-25

Results Overview

All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)

Recruitment status

COMPLETED

Study phase

Target enrollment

2777 participants

Primary outcome timeframe

1 year

Results posted on

2022-10-25

Participant Flow

Between February 21, 2012 and April 15, 2014, 1658 subjects were enrolled in the Continued Access Extreme Risk Study at 45 centers in the US. Between October 19, 2012 and August 12, 2014, 1119 subjects were enrolled in the High Risk Study at the same 45 US centers.

Participant milestones

Participant milestones
Measure	Extreme Risk: Iliofemoral Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Overall Study STARTED	1285	373	1119
Overall Study COMPLETED	921	231	836
Overall Study NOT COMPLETED	364	142	283

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Total n=2732 Participants Total of all reporting groups
Age, Continuous	83.5 years STANDARD_DEVIATION 8.1 • n=5 Participants	81.9 years STANDARD_DEVIATION 8.2 • n=7 Participants	83.6 years STANDARD_DEVIATION 7.1 • n=5 Participants	83.3 years STANDARD_DEVIATION 7.7 • n=4 Participants
Sex: Female, Male Female	568 Participants n=5 Participants	185 Participants n=7 Participants	456 Participants n=5 Participants	1209 Participants n=4 Participants
Sex: Female, Male Male	689 Participants n=5 Participants	182 Participants n=7 Participants	652 Participants n=5 Participants	1523 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	37 Participants n=5 Participants	4 Participants n=7 Participants	38 Participants n=5 Participants	79 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1206 Participants n=5 Participants	360 Participants n=7 Participants	1056 Participants n=5 Participants	2622 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants	31 Participants n=4 Participants
Body Surface Area	1.9 m^2 STANDARD_DEVIATION 0.3 • n=5 Participants	1.8 m^2 STANDARD_DEVIATION 0.3 • n=7 Participants	1.9 m^2 STANDARD_DEVIATION 0.2 • n=5 Participants	1.9 m^2 STANDARD_DEVIATION 0.3 • n=4 Participants
New York Heart Association (NYHA) Classification NYHA Classification I	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
New York Heart Association (NYHA) Classification NYHA Classification II	159 participants n=5 Participants	45 participants n=7 Participants	180 participants n=5 Participants	384 participants n=4 Participants
New York Heart Association (NYHA) Classification NYHA Classification III	881 participants n=5 Participants	248 participants n=7 Participants	811 participants n=5 Participants	1940 participants n=4 Participants
New York Heart Association (NYHA) Classification NYHA Classification IV	217 participants n=5 Participants	74 participants n=7 Participants	117 participants n=5 Participants	408 participants n=4 Participants
Society of Thoracic Surgeons (STS) Risk Score	9.1 Percent of predicted mortality STANDARD_DEVIATION 5.1 • n=5 Participants	10.2 Percent of predicted mortality STANDARD_DEVIATION 5.6 • n=7 Participants	7.7 Percent of predicted mortality STANDARD_DEVIATION 3.3 • n=5 Participants	8.7 Percent of predicted mortality STANDARD_DEVIATION 4.6 • n=4 Participants
Logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE)	24.2 Percent of predicted mortality STANDARD_DEVIATION 17.1 • n=5 Participants	24.2 Percent of predicted mortality STANDARD_DEVIATION 17.1 • n=7 Participants	20.3 Percent of predicted mortality STANDARD_DEVIATION 13.5 • n=5 Participants	22.6 Percent of predicted mortality STANDARD_DEVIATION 15.9 • n=4 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Participant Population = Consisted of all subjects with an attempted implant procedure.

All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality	22.5 percentage of participants, Kaplan-Meier	30.8 percentage of participants, Kaplan-Meier	17.8 percentage of participants, Kaplan-Meier

SECONDARY outcome

Timeframe: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

Population: Participant Population = Consisted of all subjects with an attempted implant procedure.

MACCE is defined as a composite of: * All-Cause Death * Myocardial Infarction (MI) * All Stroke * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) 30 day	9.1 percentage of participants, Kaplan-Meier	16.1 percentage of participants, Kaplan-Meier	8.9 percentage of participants, Kaplan-Meier
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) 6 month	19.2 percentage of participants, Kaplan-Meier	28.4 percentage of participants, Kaplan-Meier	17.2 percentage of participants, Kaplan-Meier
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) 1 year	26.6 percentage of participants, Kaplan-Meier	36.2 percentage of participants, Kaplan-Meier	24.3 percentage of participants, Kaplan-Meier

SECONDARY outcome

Timeframe: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

Population: Participant Population = Consisted of all subjects with an attempted implant procedure.

Individual MACCE Components Include: * All Cause Mortality * MI * All stroke * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
The Occurrence of Individual MACCE Components 30 day Stroke	4.6 percentage of participants, Kaplan-Meier	5.9 percentage of participants, Kaplan-Meier	4.7 percentage of participants, Kaplan-Meier
The Occurrence of Individual MACCE Components 30 day Reintervention	0.6 percentage of participants, Kaplan-Meier	0.8 percentage of participants, Kaplan-Meier	0.4 percentage of participants, Kaplan-Meier
The Occurrence of Individual MACCE Components 6 month All Cause Mortality	13.7 percentage of participants, Kaplan-Meier	20.8 percentage of participants, Kaplan-Meier	12.0 percentage of participants, Kaplan-Meier
The Occurrence of Individual MACCE Components 30 day All Cause Mortality	4.5 percentage of participants, Kaplan-Meier	9.6 percentage of participants, Kaplan-Meier	4.9 percentage of participants, Kaplan-Meier
The Occurrence of Individual MACCE Components 30 day MI	1.1 percentage of participants, Kaplan-Meier	1.4 percentage of participants, Kaplan-Meier	0.4 percentage of participants, Kaplan-Meier
The Occurrence of Individual MACCE Components 6 month MI	1.6 percentage of participants, Kaplan-Meier	2.7 percentage of participants, Kaplan-Meier	1.0 percentage of participants, Kaplan-Meier
The Occurrence of Individual MACCE Components 6 month Stroke	6.6 percentage of participants, Kaplan-Meier	8.2 percentage of participants, Kaplan-Meier	7.0 percentage of participants, Kaplan-Meier
The Occurrence of Individual MACCE Components 6 month Reintervention	0.9 percentage of participants, Kaplan-Meier	0.8 percentage of participants, Kaplan-Meier	0.8 percentage of participants, Kaplan-Meier
The Occurrence of Individual MACCE Components 1 year All Cause Mortality	21.0 percentage of participants, Kaplan-Meier	29.4 percentage of participants, Kaplan-Meier	17.8 percentage of participants, Kaplan-Meier
The Occurrence of Individual MACCE Components 1 year MI	2.2 percentage of participants, Kaplan-Meier	3.8 percentage of participants, Kaplan-Meier	1.9 percentage of participants, Kaplan-Meier
The Occurrence of Individual MACCE Components 1 year Stroke	7.3 percentage of participants, Kaplan-Meier	9.2 percentage of participants, Kaplan-Meier	8.7 percentage of participants, Kaplan-Meier
The Occurrence of Individual MACCE Components 1 year Reintervention	1.0 percentage of participants, Kaplan-Meier	1.2 percentage of participants, Kaplan-Meier	0.8 percentage of participants, Kaplan-Meier

SECONDARY outcome

Timeframe: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

Population: Participant Population = Consisted of all subjects with an attempted implant procedure.

MAEs Include: * MACCE * Acute Kidney Injury * Cardiac Tamponade * Prosthetic Valve Dysfunction * Cardiogenic Shock * Valve Endocarditis * Life-Threatening, Disabling or Major Bleeding * Major Vascular Complication * Cardiac Perforation * Device Migration/Valve Embolism

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Major Adverse Events (MAEs) 30 day	46.3 percentage of participants, Kaplan-Meier	67.4 percentage of participants, Kaplan-Meier	48.1 percentage of participants, Kaplan-Meier
Major Adverse Events (MAEs) 6 month	53.0 percentage of participants, Kaplan-Meier	73.1 percentage of participants, Kaplan-Meier	54.5 percentage of participants, Kaplan-Meier
Major Adverse Events (MAEs) 1 year	57.7 percentage of participants, Kaplan-Meier	76.4 percentage of participants, Kaplan-Meier	59.3 percentage of participants, Kaplan-Meier

SECONDARY outcome

Timeframe: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

Population: Participant Population = Consisted of all subjects with an attempted implant procedure.

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Conduction Disturbance Requiring Permanent Pacemaker Implantation 30 day	27.2 percentage of participants, Kaplan-Meier	23.0 percentage of participants, Kaplan-Meier	28.8 percentage of participants, Kaplan-Meier
Conduction Disturbance Requiring Permanent Pacemaker Implantation 6 month	29.7 percentage of participants, Kaplan-Meier	24.6 percentage of participants, Kaplan-Meier	30.5 percentage of participants, Kaplan-Meier
Conduction Disturbance Requiring Permanent Pacemaker Implantation 1 year	31.1 percentage of participants, Kaplan-Meier	25.5 percentage of participants, Kaplan-Meier	32.1 percentage of participants, Kaplan-Meier

SECONDARY outcome

Timeframe: Baseline to 30 days, baseline to 6 months, baseline to 1 year. The 2-5 year outcome data will be reported once data set is complete.

Population: Participant Population = Consisted of all subjects with an attempted implant procedure.

Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement. NYHA Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Change From Baseline in NYHA Class Baseline to 30 days	-1.2 average classification level change Standard Deviation 0.8	-1.1 average classification level change Standard Deviation 0.9	-1.2 average classification level change Standard Deviation 0.8
Change From Baseline in NYHA Class Baseline to 6 month	-1.4 average classification level change Standard Deviation 0.8	-1.4 average classification level change Standard Deviation 0.8	-1.4 average classification level change Standard Deviation 0.8
Change From Baseline in NYHA Class Baseline to 1 year	-1.4 average classification level change Standard Deviation 0.8	-1.4 average classification level change Standard Deviation 0.9	-1.4 average classification level change Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline to 30 days, baseline to 1 year

Population: Participant Population = Consisted of all subjects with an attempted implant procedure.

Change in distance walked during 6MWT from baseline

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Change From Baseline in Distance Walked During 6-Minute Walk Test (6MWT) Baseline to 30 day	46.3 meters Standard Deviation 116.4	4.0 meters Standard Deviation 110.4	38.1 meters Standard Deviation 100.0
Change From Baseline in Distance Walked During 6-Minute Walk Test (6MWT) Baseline to 1 year	58.8 meters Standard Deviation 121.2	28.5 meters Standard Deviation 137.4	55.5 meters Standard Deviation 117.9

SECONDARY outcome

Timeframe: 1 year

Population: Participant Population= Consisted of all subjects with an attempted implant procedure.

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Ratio of Days Alive Out of Hospital at 365 Days Post Procedure Versus Total Days Alive	0.8 ratio of days alive and out of hospital Standard Deviation 0.3	0.7 ratio of days alive and out of hospital Standard Deviation 0.4	0.8 ratio of days alive and out of hospital Standard Deviation 0.3

SECONDARY outcome

Timeframe: 30 day, 6 month, 1 year. The 2-5 year outcome data will be reported once data set is complete.

Population: Participant Population = Consisted of all subjects with an attempted implant procedure.

QoL summary score change from baseline using the following measures: * Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * 12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Quality of Life (QoL) Change 30 day KCCQ- Overall	26.3 units on a scale Standard Deviation 26.4	19.9 units on a scale Standard Deviation 29.8	19.9 units on a scale Standard Deviation 25.0
Quality of Life (QoL) Change 30 day KCCQ- Clinical	21.7 units on a scale Standard Deviation 26.6	16.5 units on a scale Standard Deviation 30.2	16.6 units on a scale Standard Deviation 24.0
Quality of Life (QoL) Change 30 day SF-12-Physical	7.1 units on a scale Standard Deviation 10.7	5.1 units on a scale Standard Deviation 10.7	5.7 units on a scale Standard Deviation 10.2
Quality of Life (QoL) Change 30 day SF-12-Mental	6.0 units on a scale Standard Deviation 13.9	4.5 units on a scale Standard Deviation 14.5	3.0 units on a scale Standard Deviation 12.4
Quality of Life (QoL) Change 30 day EQ-5D	0.10 units on a scale Standard Deviation 0.26	0.07 units on a scale Standard Deviation 0.30	0.05 units on a scale Standard Deviation 0.21
Quality of Life (QoL) Change 6 month KCCQ- Overall	31.7 units on a scale Standard Deviation 27.3	29.6 units on a scale Standard Deviation 28.5	26.2 units on a scale Standard Deviation 25.0
Quality of Life (QoL) Change 6 month KCCQ- Clinical	25.8 units on a scale Standard Deviation 27.7	23.2 units on a scale Standard Deviation 28.5	20.8 units on a scale Standard Deviation 24.7
Quality of Life (QoL) Change 1 year KCCQ- Clinical	23.8 units on a scale Standard Deviation 27.9	21.7 units on a scale Standard Deviation 27.2	21.0 units on a scale Standard Deviation 24.0
Quality of Life (QoL) Change 6 month SF-12-Physical	7.6 units on a scale Standard Deviation 11.1	6.8 units on a scale Standard Deviation 11.4	7.1 units on a scale Standard Deviation 10.7
Quality of Life (QoL) Change 6 month SF-12-Mental	6.9 units on a scale Standard Deviation 13.9	7.9 units on a scale Standard Deviation 14.9	4.4 units on a scale Standard Deviation 11.8
Quality of Life (QoL) Change 6 month EQ-5D	0.10 units on a scale Standard Deviation 0.25	0.11 units on a scale Standard Deviation 0.27	0.06 units on a scale Standard Deviation 0.21
Quality of Life (QoL) Change 1 year KCCQ- Overall	30.0 units on a scale Standard Deviation 27.5	28.7 units on a scale Standard Deviation 27.5	27.1 units on a scale Standard Deviation 24.7
Quality of Life (QoL) Change 1 year SF-12-Physical	6.6 units on a scale Standard Deviation 11.7	6.4 units on a scale Standard Deviation 11.4	6.6 units on a scale Standard Deviation 11.1
Quality of Life (QoL) Change 1 year SF-12-Mental	6.6 units on a scale Standard Deviation 13.9	6.4 units on a scale Standard Deviation 13.8	4.7 units on a scale Standard Deviation 12.3
Quality of Life (QoL) Change 1 year EQ-5D	0.08 units on a scale Standard Deviation 0.26	0.08 units on a scale Standard Deviation 0.27	0.05 units on a scale Standard Deviation 0.21

SECONDARY outcome

Timeframe: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

Population: Participant Population = Consisted of all subjects with a valve implanted.

Using the following measure: • Effective Orifice Area (EOA) analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement.

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1615 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=1102 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Echocardiographic Assessment of Valve Performance 30 day	1.77 cm^2 Standard Deviation 0.53	1.77 cm^2 Standard Deviation 0.51	—
Echocardiographic Assessment of Valve Performance 6 month	1.75 cm^2 Standard Deviation 0.54	1.78 cm^2 Standard Deviation 0.49	—
Echocardiographic Assessment of Valve Performance 1 year	1.78 cm^2 Standard Deviation 0.54	1.77 cm^2 Standard Deviation 0.51	—

SECONDARY outcome

Timeframe: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

Population: Participant Population= Consisted of all subjects with a valve implanted.

Using the following measure: • Transvalvular Mean Gradient analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement.

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1615 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=1102 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Echocardiographic Assessment of Valve Performance 30 day	8.20 mmHg Standard Deviation 4.26	8.02 mmHg Standard Deviation 3.53	—
Echocardiographic Assessment of Valve Performance 6 month	7.98 mmHg Standard Deviation 3.63	7.97 mmHg Standard Deviation 3.48	—
Echocardiographic Assessment of Valve Performance 1 year	7.72 mmHg Standard Deviation 3.40	8.12 mmHg Standard Deviation 3.93	—

SECONDARY outcome

Timeframe: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

Population: Participant Population = Consisted of all subjects with a valve implanted.

Using the following measure: \- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular) analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement.

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1615 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=1102 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Echocardiographic Assessment of Valve Performance 30 day Total Aortic Regurgitation- None	26.5 percentage of participants	28.7 percentage of participants	—
Echocardiographic Assessment of Valve Performance 30 day Total Aortic Regurgitation- Mild	66.3 percentage of participants	65.2 percentage of participants	—
Echocardiographic Assessment of Valve Performance 30 day Total Aortic Regurgitation- Moderate	6.9 percentage of participants	5.8 percentage of participants	—
Echocardiographic Assessment of Valve Performance 30 day Total Aortic Regurgitation- Severe	0.3 percentage of participants	0.3 percentage of participants	—
Echocardiographic Assessment of Valve Performance 6 month Total Aortic Regurgitation- None	35.1 percentage of participants	37.8 percentage of participants	—
Echocardiographic Assessment of Valve Performance 6 month Total Aortic Regurgitation- Mild	58.5 percentage of participants	58.1 percentage of participants	—
Echocardiographic Assessment of Valve Performance 6 month Total Aortic Regurgitation- Moderate	6.1 percentage of participants	4.0 percentage of participants	—
Echocardiographic Assessment of Valve Performance 6 month Total Aortic Regurgitation- Severe	0.2 percentage of participants	0.1 percentage of participants	—
Echocardiographic Assessment of Valve Performance 1 year Total Aortic Regurgitation- None	39.8 percentage of participants	39.9 percentage of participants	—
Echocardiographic Assessment of Valve Performance 1 year Total Aortic Regurgitation- Mild	54.9 percentage of participants	56.0 percentage of participants	—
Echocardiographic Assessment of Valve Performance 1 year Total Aortic Regurgitation- Moderate	5.1 percentage of participants	3.8 percentage of participants	—
Echocardiographic Assessment of Valve Performance 1 year Total Aortic Regurgitation- Severe	0.2 percentage of participants	0.3 percentage of participants	—

SECONDARY outcome

Timeframe: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

Population: Participant Population = Consisted of all subjects with an attempted implant procedure.

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Aortic Valve Hospitalizations 30 day	6.2 percentage of participants, Kaplan-Meier	5.5 percentage of participants, Kaplan-Meier	5.6 percentage of participants, Kaplan-Meier
Aortic Valve Hospitalizations 6 month	12.5 percentage of participants, Kaplan-Meier	12.9 percentage of participants, Kaplan-Meier	11.8 percentage of participants, Kaplan-Meier
Aortic Valve Hospitalizations 1 year	17.1 percentage of participants, Kaplan-Meier	16.5 percentage of participants, Kaplan-Meier	15.4 percentage of participants, Kaplan-Meier

SECONDARY outcome

Timeframe: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

Population: Participant Population = Consisted of all subjects with an attempted implant procedure.

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Cardiovascular Deaths and Valve-Related Deaths 30 day Cardiovascular Deaths	4.4 percentage of participants, Kaplan-Meier	9.3 percentage of participants, Kaplan-Meier	4.6 percentage of participants, Kaplan-Meier
Cardiovascular Deaths and Valve-Related Deaths 30 day Valve Related Deaths	1.9 percentage of participants, Kaplan-Meier	4.2 percentage of participants, Kaplan-Meier	2.4 percentage of participants, Kaplan-Meier
Cardiovascular Deaths and Valve-Related Deaths 6 month Cardiovascular Deaths	11.3 percentage of participants, Kaplan-Meier	16.3 percentage of participants, Kaplan-Meier	9.4 percentage of participants, Kaplan-Meier
Cardiovascular Deaths and Valve-Related Deaths 6 month Valve Related Deaths	3.9 percentage of participants, Kaplan-Meier	5.7 percentage of participants, Kaplan-Meier	3.8 percentage of participants, Kaplan-Meier
Cardiovascular Deaths and Valve-Related Deaths 1 year Cardiovascular Deaths	16.6 percentage of participants, Kaplan-Meier	22.0 percentage of participants, Kaplan-Meier	13.0 percentage of participants, Kaplan-Meier
Cardiovascular Deaths and Valve-Related Deaths 1 year Valve Related Deaths	5.5 percentage of participants, Kaplan-Meier	6.4 percentage of participants, Kaplan-Meier	4.2 percentage of participants, Kaplan-Meier

SECONDARY outcome

Timeframe: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

Population: Participant Population = Consisted of all subjects with an attempted implant procedure.

Strokes (of any severity) and TIAs

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Strokes and Transient Ischemic Attacks (TIAs) 1 year Stroke	7.3 percentage of participants, Kaplan-Meier	9.2 percentage of participants, Kaplan-Meier	8.7 percentage of participants, Kaplan-Meier
Strokes and Transient Ischemic Attacks (TIAs) 30 day Stroke	4.6 percentage of participants, Kaplan-Meier	5.9 percentage of participants, Kaplan-Meier	4.7 percentage of participants, Kaplan-Meier
Strokes and Transient Ischemic Attacks (TIAs) 30 day TIA	0.7 percentage of participants, Kaplan-Meier	0.3 percentage of participants, Kaplan-Meier	0.7 percentage of participants, Kaplan-Meier
Strokes and Transient Ischemic Attacks (TIAs) 6 month Stroke	6.6 percentage of participants, Kaplan-Meier	8.2 percentage of participants, Kaplan-Meier	6.8 percentage of participants, Kaplan-Meier
Strokes and Transient Ischemic Attacks (TIAs) 6 month TIA	1.4 percentage of participants, Kaplan-Meier	0.9 percentage of participants, Kaplan-Meier	2.2 percentage of participants, Kaplan-Meier
Strokes and Transient Ischemic Attacks (TIAs) 1 year TIA	2.0 percentage of participants, Kaplan-Meier	0.9 percentage of participants, Kaplan-Meier	2.9 percentage of participants, Kaplan-Meier

SECONDARY outcome

Timeframe: Procedure

Population: Participant Population = Consisted of all subjects with an attempted implant procedure.

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Index Procedure Related MAEs	46.4 percentage of participants	66.6 percentage of participants	48.1 percentage of participants

SECONDARY outcome

Timeframe: Number of days from admission to discharge

Population: Participant Population = Consisted of all subjects with an attempted implant procedure.

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1257 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=367 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1108 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Length of Index Procedure Hospital Stay	7.6 days Standard Deviation 6.9	10.7 days Standard Deviation 8.7	7.6 days Standard Deviation 5.9

SECONDARY outcome

Timeframe: Number of days from admission to discharge

Population: Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for device success.

Defined as: * Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system, * Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function), * Intended performance of the prosthetic valve (aortic valve area \> 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation) * Only one valve implanted in the proper anatomical location

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1252 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=365 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1104 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Device Success	84.9 percentage of participants	88.1 percentage of participants	87.9 percentage of participants

SECONDARY outcome

Timeframe: Number of days from admission to discharge

Population: Participant Population = Consisted of all subjects with an index procedure who were evaluable for procedural success.

Defined as device success and absence of in-hospital MACCE.

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1252 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=365 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1104 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Procedural Success	79.7 percentage of participants	76.8 percentage of participants	82.3 percentage of participants

SECONDARY outcome

Timeframe: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.

Population: Participant Population = Consisted of all subjects with a valve implanted.

PVD was defined according to VARC using the site reported echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met: * Peak velocity \>4 m/s * Mean gradient \>35 mmHg * EOA \< 0.8 cm2 * TVIV1 / TVIV2 \< 0.25

Outcome measures

Outcome measures
Measure	Extreme Risk: Iliofemoral n=1251 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: Non-Iliofemoral n=364 Participants Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk n=1102 Participants High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Prosthetic Valve Dysfunction (PVD) 30 day Aortic Stenosis	1.0 Percentage of participants	0.8 Percentage of participants	0.9 Percentage of participants
Prosthetic Valve Dysfunction (PVD) 30 day Aortic Regurgitation	3.0 Percentage of participants	1.9 Percentage of participants	2.0 Percentage of participants
Prosthetic Valve Dysfunction (PVD) 6 month Aortic Stenosis	2.2 Percentage of participants	0.8 Percentage of participants	2.0 Percentage of participants
Prosthetic Valve Dysfunction (PVD) 6 month Aortic Regurgitation	5.0 Percentage of participants	3.3 Percentage of participants	3.1 Percentage of participants
Prosthetic Valve Dysfunction (PVD) 1 year Aortic Stenosis	2.8 Percentage of participants	1.6 Percentage of participants	2.5 Percentage of participants
Prosthetic Valve Dysfunction (PVD) 1 year Aortic Regurgitation	5.8 Percentage of participants	3.8 Percentage of participants	4.5 Percentage of participants

Adverse Events

Extreme Risk: TAVI Iliofemoral

Serious events: 1117 serious events

Other events: 1097 other events

Deaths: 0 deaths

Extreme Risk: TAVI Non-Iliofemoral

Serious events: 359 serious events

Other events: 327 other events

Deaths: 0 deaths

High Risk: TAVI

Serious events: 1004 serious events

Other events: 1001 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Hatice Bilgic Lim

Medtronic, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Extreme Risk: TAVI Iliofemoral n=1257 participants at risk Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: TAVI Non-Iliofemoral n=367 participants at risk Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk: TAVI n=1108 participants at risk High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Eye disorders Retinal Structural Change, Deposit And Degeneration	0.16% 2/1257 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/367 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.18% 2/1108 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Gastrointestinal disorders Peritoneal And Retroperitoneal Haemorrhages	0.40% 5/1257 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.27% 1/367 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.81% 9/1108 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Eye disorders Retinal, Choroid And Vitreous Infections And Inflammations	0.08% 1/1257 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/367 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/1108 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Cardiac Disorders	1.0% 13/1257 • Number of events 13 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	1.4% 5/367 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	1.2% 13/1108 • Number of events 13 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Cardiac Signs And Symptoms	0.08% 1/1257 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/367 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.27% 3/1108 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Cardiac Valve Disorders	0.08% 1/1257 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/367 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/1108 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Blood and lymphatic system disorders Anaemia Deficiencies	0.56% 7/1257 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.82% 3/367 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.54% 6/1108 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Blood and lymphatic system disorders Anaemias Due To Chronic Disorders	0.16% 2/1257 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.82% 3/367 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.18% 2/1108 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Blood and lymphatic system disorders Anaemias	27.0% 340/1257 • Number of events 420 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	40.9% 150/367 • Number of events 182 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	23.9% 265/1108 • Number of events 319 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Blood and lymphatic system disorders Coagulopathies	0.72% 9/1257 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	1.6% 6/367 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.54% 6/1108 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Blood and lymphatic system disorders Haemolyses	0.00% 0/1257 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.27% 1/367 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.09% 1/1108 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Blood and lymphatic system disorders Leukocytoses	0.72% 9/1257 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	1.1% 4/367 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	1.2% 13/1108 • Number of events 13 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Blood and lymphatic system disorders Lymphatic System Disorders	0.00% 0/1257 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.27% 1/367 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.09% 1/1108 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Blood and lymphatic system disorders Marrow Depression And Hypoplastic Anaemias	0.24% 3/1257 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	1.1% 4/367 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.18% 2/1108 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Blood and lymphatic system disorders Spleen Disorders	0.08% 1/1257 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/367 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.18% 2/1108 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Blood and lymphatic system disorders Thrombocytopenias	2.7% 34/1257 • Number of events 34 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	4.6% 17/367 • Number of events 17 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	1.8% 20/1108 • Number of events 21 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Aortic Valvular Disorders	11.4% 143/1257 • Number of events 153 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	7.1% 26/367 • Number of events 29 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	9.3% 103/1108 • Number of events 108 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Cardiac Conduction Disorders	23.3% 293/1257 • Number of events 311 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	17.2% 63/367 • Number of events 66 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	25.0% 277/1108 • Number of events 296 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Cardiomyopathies	1.3% 16/1257 • Number of events 16 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.82% 3/367 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.54% 6/1108 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Coronary Artery Disorders	2.1% 26/1257 • Number of events 28 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	1.9% 7/367 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.90% 10/1108 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Heart Failures	26.2% 329/1257 • Number of events 531 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	28.6% 105/367 • Number of events 147 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	22.4% 248/1108 • Number of events 346 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Ischaemic Coronary Artery Disorders	7.2% 91/1257 • Number of events 102 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	7.1% 26/367 • Number of events 30 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	7.0% 78/1108 • Number of events 97 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Left Ventricular Failures	0.08% 1/1257 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/367 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/1108 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Mitral Valvular Disorders	2.9% 36/1257 • Number of events 37 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.82% 3/367 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	2.5% 28/1108 • Number of events 30 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Myocardial Disorders	0.48% 6/1257 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	1.4% 5/367 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.81% 9/1108 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Pericardial Disorders	1.8% 22/1257 • Number of events 24 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	2.2% 8/367 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	2.7% 30/1108 • Number of events 33 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Pulmonary Valvular Disorders	0.08% 1/1257 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/367 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/1108 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Rate And Rhythm Disorders	6.0% 75/1257 • Number of events 77 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	5.4% 20/367 • Number of events 21 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	4.5% 50/1108 • Number of events 54 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Right Ventricular Failures	0.32% 4/1257 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.27% 1/367 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.36% 4/1108 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Supraventricular Arrhythmias	12.1% 152/1257 • Number of events 184 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	12.8% 47/367 • Number of events 55 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	10.7% 119/1108 • Number of events 137 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Tricuspid Valvular Disorders	0.88% 11/1257 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.27% 1/367 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.45% 5/1108 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Ventricular Arrhythmias And Cardiac Arrest	11.1% 139/1257 • Number of events 150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	11.7% 43/367 • Number of events 49 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	9.4% 104/1108 • Number of events 113 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Congenital, familial and genetic disorders Cardiac Malpositions Congenital	0.08% 1/1257 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/367 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/1108 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Congenital, familial and genetic disorders Cardiac Septal Defects Congenital	0.16% 2/1257 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/367 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.27% 3/1108 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Congenital, familial and genetic disorders Cardiovascular Disorders Congenital	0.08% 1/1257 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/367 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.09% 1/1108 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Congenital, familial and genetic disorders Male Reproductive Tract Disorders Congenital	0.00% 0/1257 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/367 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.09% 1/1108 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Congenital, familial and genetic disorders Vascular Anomalies Congenital	0.16% 2/1257 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.27% 1/367 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/1108 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Ear and labyrinth disorders Eustachian Tube Disorders	0.08% 1/1257 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/367 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/1108 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Ear and labyrinth disorders External Ear Disorders	0.16% 2/1257 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/367 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.00% 0/1108 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Ear and labyrinth disorders Inner Ear Signs And Symptoms	0.56% 7/1257 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.82% 3/367 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	0.18% 2/1108 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.

Other adverse events
Measure	Extreme Risk: TAVI Iliofemoral n=1257 participants at risk Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Extreme Risk: TAVI Non-Iliofemoral n=367 participants at risk Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	High Risk: TAVI n=1108 participants at risk High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Blood and lymphatic system disorders Anaemias	19.4% 244/1257 • Number of events 259 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	25.1% 92/367 • Number of events 96 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	23.5% 260/1108 • Number of events 267 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Blood and lymphatic system disorders Leukocytoses	6.5% 82/1257 • Number of events 88 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	10.4% 38/367 • Number of events 40 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	7.1% 79/1108 • Number of events 81 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Blood and lymphatic system disorders Thrombocytopenias	13.9% 175/1257 • Number of events 182 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	19.1% 70/367 • Number of events 74 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	19.6% 217/1108 • Number of events 223 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Cardiac Conduction Disorders	22.8% 286/1257 • Number of events 335 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	15.3% 56/367 • Number of events 65 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	29.9% 331/1108 • Number of events 387 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Heart Failures	7.6% 96/1257 • Number of events 107 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	8.2% 30/367 • Number of events 31 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.1% 68/1108 • Number of events 74 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Rate And Rhythm Disorders	6.8% 85/1257 • Number of events 92 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	7.6% 28/367 • Number of events 30 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	8.9% 99/1108 • Number of events 105 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Supraventricular Arrhythmias	12.2% 153/1257 • Number of events 174 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	19.6% 72/367 • Number of events 81 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	14.4% 159/1108 • Number of events 186 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Cardiac disorders Ventricular Arrhythmias And Cardiac Arrest	5.1% 64/1257 • Number of events 69 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	4.1% 15/367 • Number of events 16 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.0% 66/1108 • Number of events 69 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Gastrointestinal disorders Gastrointestinal Atonic And Hypomotility Disorders	5.3% 66/1257 • Number of events 70 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	7.4% 27/367 • Number of events 27 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.7% 74/1108 • Number of events 78 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Gastrointestinal disorders Nausea And Vomiting Symptoms	4.5% 57/1257 • Number of events 61 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	5.2% 19/367 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	4.1% 45/1108 • Number of events 51 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
General disorders Asthenic Conditions	4.5% 57/1257 • Number of events 63 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.3% 23/367 • Number of events 25 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	3.9% 43/1108 • Number of events 44 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
General disorders Febrile Disorders	6.0% 75/1257 • Number of events 77 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.5% 24/367 • Number of events 25 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.2% 69/1108 • Number of events 71 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
General disorders Oedema	7.4% 93/1257 • Number of events 102 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	4.6% 17/367 • Number of events 17 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	7.7% 85/1108 • Number of events 95 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
General disorders Pain And Discomfort	5.7% 72/1257 • Number of events 86 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.0% 22/367 • Number of events 29 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.4% 71/1108 • Number of events 84 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Infections and infestations Lower Respiratory Tract And Lung Infections	5.3% 67/1257 • Number of events 75 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.0% 22/367 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	5.0% 55/1108 • Number of events 58 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Infections and infestations Urinary Tract Infections	11.9% 149/1257 • Number of events 182 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	12.3% 45/367 • Number of events 46 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	12.7% 141/1108 • Number of events 164 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Injury, poisoning and procedural complications Non-Site Specific Injuries	6.8% 86/1257 • Number of events 93 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	4.4% 16/367 • Number of events 19 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.1% 68/1108 • Number of events 77 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Injury, poisoning and procedural complications Non-Site Specific Procedural Complications	5.9% 74/1257 • Number of events 80 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.8% 25/367 • Number of events 27 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	7.9% 87/1108 • Number of events 92 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Investigations Skeletal And Cardiac Muscle Analyses	4.1% 52/1257 • Number of events 54 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.8% 25/367 • Number of events 26 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	3.8% 42/1108 • Number of events 43 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Metabolism and nutrition disorders Hyperglycaemic Conditions	2.6% 33/1257 • Number of events 34 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	7.4% 27/367 • Number of events 27 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	4.2% 46/1108 • Number of events 46 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Metabolism and nutrition disorders Magnesium Metabolism Disorders	2.0% 25/1257 • Number of events 25 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	3.3% 12/367 • Number of events 14 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	5.8% 64/1108 • Number of events 65 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Metabolism and nutrition disorders Potassium Imbalance	6.7% 84/1257 • Number of events 96 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	9.3% 34/367 • Number of events 35 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	7.9% 87/1108 • Number of events 99 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Metabolism and nutrition disorders Sodium Imbalance	4.9% 61/1257 • Number of events 68 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	7.6% 28/367 • Number of events 29 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	5.2% 58/1108 • Number of events 63 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Metabolism and nutrition disorders Total Fluid Volume Increased	6.8% 85/1257 • Number of events 89 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	7.6% 28/367 • Number of events 28 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	10.5% 116/1108 • Number of events 122 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Pain And Discomfort	7.1% 89/1257 • Number of events 100 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	7.9% 29/367 • Number of events 33 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	8.9% 99/1108 • Number of events 108 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Psychiatric disorders Confusion And Disorientation	4.5% 57/1257 • Number of events 59 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.5% 24/367 • Number of events 24 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.1% 68/1108 • Number of events 69 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Renal and urinary disorders Bladder And Urethral Symptoms	2.8% 35/1257 • Number of events 35 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	3.5% 13/367 • Number of events 13 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	5.1% 57/1108 • Number of events 60 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Renal and urinary disorders Renal Failure And Impairment	13.1% 165/1257 • Number of events 199 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	15.8% 58/367 • Number of events 66 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	18.1% 201/1108 • Number of events 223 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Respiratory, thoracic and mediastinal disorders Breathing Abnormalities	6.1% 77/1257 • Number of events 81 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	4.4% 16/367 • Number of events 18 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	5.8% 64/1108 • Number of events 67 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Respiratory, thoracic and mediastinal disorders Parenchymal Lung Disorders	5.7% 72/1257 • Number of events 75 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.8% 25/367 • Number of events 25 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	8.5% 94/1108 • Number of events 98 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Respiratory, thoracic and mediastinal disorders Pneumothorax And Pleural Effusions	11.0% 138/1257 • Number of events 146 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	17.4% 64/367 • Number of events 73 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	15.2% 168/1108 • Number of events 187 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedemas	5.4% 68/1257 • Number of events 70 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	3.8% 14/367 • Number of events 14 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	6.0% 67/1108 • Number of events 69 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Vascular disorders Haemorrhages	4.4% 55/1257 • Number of events 57 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	2.5% 9/367 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	5.5% 61/1108 • Number of events 62 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Vascular disorders Vascular Hypertensive Disorders	11.6% 146/1257 • Number of events 152 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	15.3% 56/367 • Number of events 58 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	17.3% 192/1108 • Number of events 206 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.
Vascular disorders Vascular Hypotensive Disorders	11.6% 146/1257 • Number of events 162 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	12.3% 45/367 • Number of events 49 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.	10.8% 120/1108 • Number of events 131 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. All new or worsening AEs were collected through1 year. After 1 year, serious AEs, major AEs, cardiovascular events, device-related AEs, device related technical observations, unanticipated adverse device effects, strokes, and deaths were collected. AE data reported are Clinical Event Committee adjudicated AEs for subjects with an attempted implant.