Trial Outcomes & Findings for Evolut PRO China Clinical Study (NCT NCT04982588)

NCT ID: NCT04982588

Last Updated: 2025-12-03

Results Overview

All-cause mortality at 30 days

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2025-12-03

Participant Flow

Participant milestones

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 52 enrolled subjects, 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Overall Study STARTED	52
Overall Study Exited Prior to Procedure	2
Overall Study Implanted	49
Overall Study Attempted, Not Implanted	1
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Age, Continuous	76.7 years STANDARD_DEVIATION 7.3 • n=50 Participants
Sex: Female, Male Female	30 Participants n=50 Participants
Sex: Female, Male Male	20 Participants n=50 Participants
Region of Enrollment China	50 participants n=50 Participants
BSA	1.6 m^2 STANDARD_DEVIATION 0.2 • n=50 Participants
NYHA I	0 Participants n=50 Participants
NYHA II	6 Participants n=50 Participants
NYHA III	26 Participants n=50 Participants
NYHA IV	18 Participants n=50 Participants
STS Score	5.6 % STANDARD_DEVIATION 3.3 • n=50 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Number of attempted implant population

All-cause mortality at 30 days

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
All-cause Mortality	0.0 Percent of Participants (K-M Rate)	—	—

PRIMARY outcome

Timeframe: 30 days

Population: Number of subjects with evaluable aortic regurgitation from echo core lab

Percentage (%) of Subjects with evaluable echocardiograms with moderate or severe aortic regurgitation by transthoracic echocardiography (TTE)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=45 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Percentage (%) of Subjects With Evaluable Echocardiograms With Moderate or Severe Aortic Regurgitation by Transthoracic Echocardiography (TTE)	2.2 Percentage (%) of participants Interval 0.1 to 11.8	—	—

SECONDARY outcome

Timeframe: 30 days

Population: Number of attempted implant population

Incidence of an VARC II combined composite includes the following components:

• All-cause mortality
• All stroke (disabling and non-disabling)
• Life-threatening bleeding
• Acute kidney injury: stage 2 or 3 (including renal replacement therapy)
• Coronary artery obstruction requiring intervention
• Major vascular complication
• Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of an VARC II Combined Composite	4 Percent of Participants (K-M Rate) Interval 1.0 to 15.2	—	—

SECONDARY outcome

Timeframe: 30 days

Population: Number of attempted implant population

Event rate of the individual components listed in the outcome

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Event Rates of the Individual Components of the VARC II Composite Coronary Artery Obstruction	4.0 Percent of Participants (K-M Rate)	—	—
Event Rates of the Individual Components of the VARC II Composite Major Vascular Complication	0.0 Percent of Participants (K-M Rate)	—	—
Event Rates of the Individual Components of the VARC II Composite Valve-Related Dysfunction Requiring Repeat Procedure	0.0 Percent of Participants (K-M Rate)	—	—
Event Rates of the Individual Components of the VARC II Composite All-Cause Mortality	0.0 Percent of Participants (K-M Rate)	—	—
Event Rates of the Individual Components of the VARC II Composite All Stroke	0.0 Percent of Participants (K-M Rate)	—	—
Event Rates of the Individual Components of the VARC II Composite Life Threatening or Disabling Bleeding	0.0 Percent of Participants (K-M Rate)	—	—
Event Rates of the Individual Components of the VARC II Composite Acute Kidney Injury: Stage 2 or 3	0.0 Percent of Participants (K-M Rate)	—	—

SECONDARY outcome

Timeframe: 30 days

Population: Number of attempted implant population. Subjects with a pacemaker or ICD at baseline are excluded.

New permanent pacemaker rate

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=46 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
New Permanent Pacemaker Rate	8.8 Percent of Participants (K-M Rate) Interval 3.4 to 21.9	—	—

SECONDARY outcome

Timeframe: Between 24 hours and 7 days post procedure

Population: Number of attempted implant subjects with evaluable data for device success

Device success rate:

• Percentage of participants with absence of procedural mortality, AND
• Percentage of participants with correct positioning of a single prosthetic heart valve into the proper anatomical location, AND
• Percentage of participants with intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity <3m/sec), AND absence of moderate or severe prosthetic valve regurgitation

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=36 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Device Success Rate	63.9 Percentage (%) of participants Interval 46.2 to 79.2	—	—

SECONDARY outcome

Timeframe: 30 days

Population: Number of implanted subjects with echo core lab evaluable values

Mean aortic gradient

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=43 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Valve Performance Parameter - Mean Aortic Gradient	10.7 mmHg Standard Deviation 4.9	—	—

SECONDARY outcome

Timeframe: 30 days

Population: Number of implanted subjects with echo core lab evaluable values

Effective orifice area

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=32 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Valve Performance Parameter - Effective Orifice Area	1.8 cm^2 Standard Deviation 0.4	—	—

SECONDARY outcome

Timeframe: 30 days

Population: Number of implanted subjects with echo core lab evaluable values

Degree of aortic regurgitation (transvalvular, paravalvular, total)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=45 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Transvalvular Aortic Regurgitation · Moderate to Severe	0 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Transvalvular Aortic Regurgitation · Severe	0 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Total Aortic Regurgitation · Severe	0 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Transvalvular Aortic Regurgitation · Mild to Moderate	0 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Transvalvular Aortic Regurgitation · Moderate	0 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Total Aortic Regurgitation · None	18 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Total Aortic Regurgitation · Trace	15 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Total Aortic Regurgitation · Mild	9 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Total Aortic Regurgitation · Mild to Moderate	2 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Total Aortic Regurgitation · Moderate	1 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Total Aortic Regurgitation · Moderate to Severe	0 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Paravalvular Aortic Regurgitation · None	19 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Paravalvular Aortic Regurgitation · Trace	14 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Paravalvular Aortic Regurgitation · Mild	9 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Paravalvular Aortic Regurgitation · Mild to Moderate	2 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Paravalvular Aortic Regurgitation · Moderate	1 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Paravalvular Aortic Regurgitation · Moderate to Severe	0 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Paravalvular Aortic Regurgitation · Severe	0 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Transvalvular Aortic Regurgitation · None	43 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Transvalvular Aortic Regurgitation · Trace	2 Participants	—	—
Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Transvalvular Aortic Regurgitation · Mild	0 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: Number of attempted implant population

Rate of the following TAVI-related complications:

1. change to surgery

2. need for cardiopulmonary mechanical assistance

3. coronary occlusion or obstruction

4. annular rupture or dissection

5. ventricular perforation

6. mitral valve damage

7. prosthetic valve displacement, migration, or embolism

8. acute kidney injury (up to 7 days post procedure)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Event Rates of TAVI-related Complications change to surgery	0 Percent of Participants (K-M Rate)	—	—
Event Rates of TAVI-related Complications need for cardiopulmonary mechanical assistance	0 Percent of Participants (K-M Rate)	—	—
Event Rates of TAVI-related Complications coronary occlusion or obstruction	4.0 Percent of Participants (K-M Rate)	—	—
Event Rates of TAVI-related Complications annular rupture or dissection	0 Percent of Participants (K-M Rate)	—	—
Event Rates of TAVI-related Complications ventricular perforation	0 Percent of Participants (K-M Rate)	—	—
Event Rates of TAVI-related Complications mitral valve damage	0 Percent of Participants (K-M Rate)	—	—
Event Rates of TAVI-related Complications prosthetic valve displacement, migration, or embolism	2.0 Percent of Participants (K-M Rate)	—	—
Event Rates of TAVI-related Complications acute kidney injury	0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Number of attempted implant population

Percentage of participants with all-cause mortality

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
All-cause Mortality	2.0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Number of attempted implant population

Percentage of participants with all-cause mortality

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
All-cause Mortality	8.2 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Number of attempted implant population

Incidence of stroke (disabling and non-disabling)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
All Stroke	2.0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Number of attempted implant population

Incidence of stroke (disabling and non-disabling)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
All Stroke	4.1 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: Number of attempted implant population

Incidence of MI

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Myocardial Infarction	2.0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Number of attempted implant population

Incidence of MI

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Myocardial Infarction	2.0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Year

Population: Number of attempted implant population

Incidence of MI

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Myocardial Infarction	4.1 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: Number of attempted implant population

Incidence of life-threatening bleeding:

1. Fatal bleeding (BARC type 5) OR

2. Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR

3. Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR

4. Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* (BARC type 3b)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Life-threatening Bleeding	0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Number of attempted implant population

Incidence of life-threatening bleeding:

1. Fatal bleeding (BARC type 5) OR

2. Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR

3. Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR

4. Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* (BARC type 3b)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Life-threatening Bleeding	0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Year

Population: Number of attempted implant population

Incidence of life-threatening bleeding:

1. Fatal bleeding (BARC type 5) OR

2. Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR

3. Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR

4. Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* (BARC type 3b)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Life-threatening Bleeding	0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: Number of attempted implant population. Subjects with LBBB or RBBB at baseline are excluded

Incidence of either LBBB or RBBB

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=42 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
New AV-Conduction Disturbances (Left Bundle Branch Block (LBBB) and Right Bundle Branch Block (RBBB))	5 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: Number of attempted implant population

Incidence of prosthetic valve endocarditis:

Any one of the following:

1. Fulfillment of the following Duke criteria for definite endocarditis

• Histologic and/or microbiologic evidence of infection at surgery or autopsy, or
• 2 major criteria, or
• 1 major criteria and 3 minor criteria, or
• 5 minor criteria

2. Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation

3. Findings of abscess, pus, or vegetation involving the CoreValve™ Evolut™ PRO at autopsy

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Prosthetic Valve Endocarditis	0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Number of attempted implant population

Incidence of prosthetic valve endocarditis:

Any one of the following:

1. Fulfillment of the following Duke criteria for definite endocarditis

• Histologic and/or microbiologic evidence of infection at surgery or autopsy, or
• 2 major criteria, or
• 1 major criteria and 3 minor criteria, or
• 5 minor criteria

2. Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation

3. Findings of abscess, pus, or vegetation involving the CoreValve™ Evolut™ PRO at autopsy

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Prosthetic Valve Endocarditis	0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Year

Population: Number of attempted implant population

Incidence of prosthetic valve endocarditis:

Any one of the following:

1. Fulfillment of the following Duke criteria for definite endocarditis

• Histologic and/or microbiologic evidence of infection at surgery or autopsy, or
• 2 major criteria, or
• 1 major criteria and 3 minor criteria, or
• 5 minor criteria

2. Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation

3. Findings of abscess, pus, or vegetation involving the CoreValve™ Evolut™ PRO at autopsy

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Prosthetic Valve Endocarditis	0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: Number of attempted implant population

Incidence of Prosthetic valve thrombosis:

Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment.

*Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis.

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Prosthetic Valve Thrombosis	0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Number of attempted implant population

Incidence of Prosthetic valve thrombosis:

Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment.

*Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis.

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Prosthetic Valve Thrombosis	0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Year

Population: Number of attempted implant population

Incidence of Prosthetic valve thrombosis:

Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment.

*Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis.

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Prosthetic Valve Thrombosis	0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Year

Population: Number of implanted subjects with evaluable site-reported echo data

Incidence of valve-related dysfunction defined as moderate or severe prosthetic valve stenosis, or moderate or severe prosthetic regurgitation (per VARC II)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=32 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Valve-related Dysfunction	1 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: Number of attempted implant population

Incidence of Valve-related dysfunction requiring repeat procedure

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Valve-related Dysfunction Requiring Repeat Procedure	0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Number of attempted implant population

Incidence of Valve-related dysfunction requiring repeat procedure

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Valve-related Dysfunction Requiring Repeat Procedure	0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Year

Population: Number of attempted implant population

Incidence of Valve-related dysfunction requiring repeat procedure

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Valve-related Dysfunction Requiring Repeat Procedure	0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Number of implanted subjects with site reported echo evaluable data

Mean aortic gradient

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=34 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Valve Hemodynamic Performance Metric - Mean Aortic Gradient	10.1 mmHg Standard Deviation 4.5	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Number of implanted subjects with site reported echo evaluable data

Effective orifice area

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=32 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Valve Hemodynamic Performance Metric - Effective Orifice Area	1.68 cm^2 Standard Deviation 0.52	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Number of implanted subjects with site reported echo evaluable data

Degree of aortic regurgitation (transvalvular, paravalvular, total)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=34 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System n=34 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System n=34 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Mild to Moderate	0 Participants	0 Participants	0 Participants
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Moderate	1 Participants	1 Participants	0 Participants
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Moderate to Severe	0 Participants	0 Participants	0 Participants
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Severe	0 Participants	0 Participants	0 Participants
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Trace	8 Participants	7 Participants	1 Participants
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Mild	8 Participants	8 Participants	1 Participants
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) None	17 Participants	18 Participants	32 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: Number of attempted subjects with available NYHA

New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest).

Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.

Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.

Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.

Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=46 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
New York Heart Association (NYHA) Functional Classification NYHA I	13 Participants	—	—
New York Heart Association (NYHA) Functional Classification NYHA II	27 Participants	—	—
New York Heart Association (NYHA) Functional Classification NYHA III	5 Participants	—	—
New York Heart Association (NYHA) Functional Classification NYHA IV	1 Participants	—	—
New York Heart Association (NYHA) Functional Classification Died prior to visit	0 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 month

Population: Number of attempted subjects with available NYHA

New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest).

Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.

Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.

Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.

Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=47 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
New York Heart Association (NYHA) Functional Classification NYHA I	27 Participants	—	—
New York Heart Association (NYHA) Functional Classification NYHA II	17 Participants	—	—
New York Heart Association (NYHA) Functional Classification NYHA III	2 Participants	—	—
New York Heart Association (NYHA) Functional Classification NYHA IV	0 Participants	—	—
New York Heart Association (NYHA) Functional Classification Died prior to visit	1 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Year

Population: Number of attempted subjects with available NYHA

New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest).

Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.

Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.

Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.

Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=39 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
New York Heart Association (NYHA) Functional Classification NYHA II	19 Participants	—	—
New York Heart Association (NYHA) Functional Classification NYHA III	4 Participants	—	—
New York Heart Association (NYHA) Functional Classification NYHA IV	0 Participants	—	—
New York Heart Association (NYHA) Functional Classification Died Prior to visit	4 Participants	—	—
New York Heart Association (NYHA) Functional Classification NYHA I	12 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: Number of attempted subjects with available EQ5D

EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.

The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health.

The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided.

The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine).

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=46 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
EQ-5D Quality of Life EQ-5D Index Score	0.880 Score on a scale Standard Deviation 0.095	—	—
EQ-5D Quality of Life EQ-5D VAS Score	79.1 Score on a scale Standard Deviation 14.7	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Year

Population: Number of attempted subjects with available EQ5D

EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.

The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health.

The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided.

The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine).

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=34 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
EQ-5D Quality of Life EQ-5D Index Score	0.905 Score on a scale Standard Deviation 0.093	—	—
EQ-5D Quality of Life EQ-5D VAS Score	79.8 Score on a scale Standard Deviation 10.4	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 year

Population: Number of attempted implant population

Percentage of participants with all-cause mortality

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
All-cause Mortality	10.3 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 year

Population: Number of attempted implant population

Incidence of stroke (disabling and non-disabling)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
All Stroke	6.4 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Year

Population: Number of attempted implant population

Incidence of MI

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Myocardial Infarction	4.1 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Year

Population: Number of attempted implant population

Incidence of life-threatening bleeding:

1. Fatal bleeding (BARC type 5) OR

2. Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR

3. Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR

4. Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* (BARC type 3b)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Life-threatening Bleeding	0.0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Year

Population: Number of attempted implant population

Incidence of prosthetic valve endocarditis:

Any one of the following:

1. Fulfillment of the following Duke criteria for definite endocarditis

• Histologic and/or microbiologic evidence of infection at surgery or autopsy, or
• 2 major criteria, or
• 1 major criteria and 3 minor criteria, or
• 5 minor criteria

2. Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation

3. Findings of abscess, pus, or vegetation involving the CoreValve™ Evolut™ PRO at autopsy

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Prosthetic Valve Endocarditis	2.3 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Year

Population: Number of attempted implant population

Incidence of Prosthetic valve thrombosis:

Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment.

*Valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve related should not be reported as valve thrombosis.

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Prosthetic Valve Thrombosis	0.0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Year

Population: Number of implanted subjects with evaluable site-reported echo data

Incidence of valve-related dysfunction defined as moderate or severe prosthetic valve stenosis, or moderate or severe prosthetic regurgitation (per VARC II)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=23 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Valve-related Dysfunction	0.0 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Year

Population: Number of attempted implant population

Incidence of Valve-related dysfunction requiring repeat procedure

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Incidence of Valve-related Dysfunction Requiring Repeat Procedure	0.0 Percent of Participants (K-M Rate)	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 year

Population: Number of implanted subjects with site reported echo evaluable data

Mean aortic gradient

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=25 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Valve Hemodynamic Performance Metric - Mean Aortic Gradient	9.8 mmHg Standard Deviation 5.0	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 year

Population: Number of implanted subjects with site reported echo evaluable data

Effective orifice area

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=23 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Valve Hemodynamic Performance Metric - Effective Orifice Area	1.73 cm^2 Standard Deviation 0.47	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 year

Population: Number of implanted subjects with site reported echo evaluable data

Degree of aortic regurgitation (transvalvular, paravalvular, total)

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=26 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System n=26 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System n=26 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Mild	8 Participants	7 Participants	2 Participants
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Mild to Moderate	0 Participants	0 Participants	0 Participants
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Moderate	0 Participants	0 Participants	0 Participants
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Moderate to Severe	0 Participants	0 Participants	0 Participants
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Severe	0 Participants	0 Participants	0 Participants
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) Trace	7 Participants	7 Participants	3 Participants
Valve Hemodynamic Performance Metric - Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total) None	11 Participants	12 Participants	21 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Year

Population: Number of attempted subjects with available NYHA

New York Heart Association (NYHA) functional classification system is a tool that classifies patients with heart failure into one of four classes according to their degree of systems at rest and with activity. Below are the four classes and the associated patient symptoms (i.e., Class I has no limitations of physical activity vs. Class IV is most symptomatic and patient has symptoms of heart failure at rest).

Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.

Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.

Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.

Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.

Outcome measures

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=41 Participants Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Paravalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.	Transvalvular Aortic Regurgitation - Experimental: Medtronic CoreValve™ Evolut™ PRO System Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
New York Heart Association (NYHA) Functional Classification Died Prior to visit	5 Participants	—	—
New York Heart Association (NYHA) Functional Classification NYHA I	7 Participants	—	—
New York Heart Association (NYHA) Functional Classification NYHA II	24 Participants	—	—
New York Heart Association (NYHA) Functional Classification NYHA III	5 Participants	—	—
New York Heart Association (NYHA) Functional Classification NYHA IV	0.0 Participants	—	—

Adverse Events

Experimental: Medtronic CoreValve™ Evolut™ PRO System

Serious events: 28 serious events

Other events: 39 other events

Deaths: 5 deaths

Serious adverse events

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 participants at risk Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Cardiac disorders Atrioventricular block complete	6.0% 3/50 • Number of events 3 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Cardiac disorders Atrioventricular block second degree	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Cardiac disorders Coronary artery stenosis	4.0% 2/50 • Number of events 2 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Cardiac disorders Coronary ostial stenosis	4.0% 2/50 • Number of events 2 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Infections and infestations Infection	4.0% 2/50 • Number of events 2 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Infections and infestations Upper respiratory tract infection	4.0% 2/50 • Number of events 2 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Investigations Blood pressure decreased	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Investigations PaO2/FiO2 ratio decreased	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Product Issues Device dislocation	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Cardiac disorders Arteriosclerosis Coronary Artery	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Cardiac disorders Cardiac Failure	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Cardiac disorders Myocardial Infarction	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Cardiac disorders Ventricular Extrasystoles	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Eye disorders Cataract	6.0% 3/50 • Number of events 4 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Gastrointestinal disorders Functional Gastrointestinal Disorder	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Gastrointestinal disorders Ileus	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
General disorders Multiple Organ Dysfunction Syndrome	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Hepatobiliary disorders Bile Duct Stone	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Hepatobiliary disorders Cholecystitis Chronic	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Hepatobiliary disorders Hepatic Cirrhosis	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Infections and infestations Cholangitis Infective	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Infections and infestations Coronavirus Pneumonia	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Infections and infestations Lower Respiratory Tract Infection	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Infections and infestations Urethritis	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Renal and urinary disorders Nephrotic Syndrome	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Nervous system disorders Cerebral Haemorrhage	4.0% 2/50 • Number of events 2 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Nervous system disorders Cerebral Infarction	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Renal and urinary disorders Chronic Kidney Disease	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Injury, poisoning and procedural complications Shoulder Fracture	4.0% 2/50 • Number of events 2 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Infections and infestations Endocarditis Bacterial	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Infections and infestations Pneumonia Klebsiella	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Infections and infestations Pneumonia Pneumococcal	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	2.0% 1/50 • Number of events 1 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.

Other adverse events

Measure	Experimental: Medtronic CoreValve™ Evolut™ PRO System n=50 participants at risk Subjects treated with the Medtronic CoreValve™ Evolut™ PRO System. Primary Study Population: 50 attempted implants The Primary Study Population Attempted Implant set (N=50)was the basis for the primary safety endpoint of the study, and the Primary Study Population Implanted set (N=49) was the basis for the assessment of the primary efficacy endpoint of the study.
Renal and urinary disorders Haematuria	6.0% 3/50 • Number of events 3 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Blood and lymphatic system disorders Thrombocytopenia	6.0% 3/50 • Number of events 3 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Metabolism and nutrition disorders Hypokalaemia	8.0% 4/50 • Number of events 5 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Metabolism and nutrition disorders Hypoproteinaemia	6.0% 3/50 • Number of events 3 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Skin and subcutaneous tissue disorders Rash	8.0% 4/50 • Number of events 4 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Metabolism and nutrition disorders Hyperkalaemia	8.0% 4/50 • Number of events 4 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Blood and lymphatic system disorders Anaemia	10.0% 5/50 • Number of events 6 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Cardiac disorders Atrial fibrillation	6.0% 3/50 • Number of events 3 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Cardiac disorders Atrioventricular block first degree	12.0% 6/50 • Number of events 6 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Cardiac disorders Bundle branch block left	28.0% 14/50 • Number of events 14 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.
Cardiac disorders Myocardial injury	8.0% 4/50 • Number of events 4 • Adverse events (AEs) were collected throughout the study duration, starting at the time of written informed consent signed. Adverse event data are currently available and reported for 2 year post-procedure. All AEs that occur during the study need to be collected by investigator or designee.

Additional Information

Fairy Liu

Medtronic, Inc.

Phone: +86-02120325765

Email: rs.evolutprochinaclinicalstudy@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee Within 60 days of receipt Medtronic (MDT) will verify presence of Confidential Information (CI) \& won't censor or interfere with presentation/conclusions except to protect CI (other than Study Data) \& its rights in patentable or copyrightable materials, \& check technical accuracy of MDT data. If told by MDT that Publication contains CI or technical errors of MDT data, PI will make requested changes before publishing/presenting. PI will delay publication up to 90 more days, if requested.
• Publication restrictions are in place

Restriction type: OTHER