Trial Outcomes & Findings for Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study (NCT NCT03635424)

NCT ID: NCT03635424

Last Updated: 2025-10-21

Results Overview

Rate of of all-cause mortality or disabling stroke rate at 30 days

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2025-10-21

Participant Flow

Participant milestones

Measure	Medtronic TAVR Systems Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Study STARTED	150
Overall Study COMPLETED	147
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Medtronic TAVR Systems Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Study Adverse Event	1
Overall Study Death	1
Overall Study Device not implanted	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Medtronic TAVR Systems n=150 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Age, Continuous	70.3 Years of age STANDARD_DEVIATION 5.5 • n=150 Participants
Sex: Female, Male Female	72 Participants n=150 Participants
Sex: Female, Male Male	78 Participants n=150 Participants
Region of Enrollment United States	150 Participants n=150 Participants
Body Surface Area (BSA)	1.9 m^2 STANDARD_DEVIATION 0.2 • n=150 Participants
Society of Thoracic Surgeons (STS) Score	1.4 % risk of mortality STANDARD_DEVIATION 0.6 • n=150 Participants
New York Heart Association (NYHA) Classification NYHA Class I	3 Participants n=150 Participants
New York Heart Association (NYHA) Classification NYHA Class II	106 Participants n=150 Participants
New York Heart Association (NYHA) Classification NYHA Class III	40 Participants n=150 Participants
New York Heart Association (NYHA) Classification NYHA Class IV	1 Participants n=150 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Attempted Implant Set

Rate of of all-cause mortality or disabling stroke rate at 30 days

Outcome measures

Measure	Medtronic TAVR Systems n=150 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure.	1.3 Percent of participants (K-M rate)

PRIMARY outcome

Timeframe: 7 days

Population: Implanted Set

Device success rate, defined as:

• Absence of procedural mortality, AND
• Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND
• Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)

Outcome measures

Measure	Medtronic TAVR Systems n=148 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure.	95.9 Percent of participants Interval 91.3 to 98.5

SECONDARY outcome

Timeframe: 1 year and annually through 10 years

Rate of all cause mortality

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year and annually through 10 years

Rate of disabling and non-disabling strokes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Population: Attempted Implant set

Rate of new permanent pacemaker implantation at 30 days post-procedure (excludes patients with pre-existing pacemaker at baseline)

Outcome measures

Measure	Medtronic TAVR Systems n=150 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Percent of Participants With New Permanent Pacemaker Implantation at 30 Days Post-procedure.	15.1 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 30 days

Population: Attempted Implant set

The rate of myocardial infarction at 30 days

Outcome measures

Measure	Medtronic TAVR Systems n=150 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Percent of Participants Who Experience a Myocardial Infarction at 30 Days Post-procedure. Myocardial infarction	0.7 Percent of participants (K-M rate)
Percent of Participants Who Experience a Myocardial Infarction at 30 Days Post-procedure. Peri-procedural myocarial infarction	0.0 Percent of participants (K-M rate)
Percent of Participants Who Experience a Myocardial Infarction at 30 Days Post-procedure. Spontaneous myocardial infarction	0.7 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 30 days

Population: Attempted Implant set

Rate of life-threatening (or disabling) bleeding at 30 days

Outcome measures

Measure	Medtronic TAVR Systems n=150 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Percent of Participants With a Life-Threatening Bleeding Event at 30 Days Post-procedure.	4.0 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 30 days

Population: Attempted Implant set

Rate of prosthetic valve endocarditis at 30 days

Outcome measures

Measure	Medtronic TAVR Systems n=150 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Percent of Participants With Prosthetic Valve Endocarditis at 30 Days Post-procedure.	0.0 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 30 days

Population: Attempted Implant set

Rate of prosthetic valve thrombosis at 30 days

Outcome measures

Measure	Medtronic TAVR Systems n=150 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Percent of Participant With Prosthetic Valve Thrombosis at 30 Days Post-procedure.	0.7 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 30 days

Population: Attempted Implant set

Rate of valve-related dysfunction requiring repeat procedure at 30 days

Outcome measures

Measure	Medtronic TAVR Systems n=150 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Percent pf Participants With Valve-Related Dysfunction Requiring Repeat Procedure at 30 Days Post-procedure.	0.0 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 30 days

Population: Attempted Implant set

Rate of repeat hospitalization for aortic valve disease at 30 days

Outcome measures

Measure	Medtronic TAVR Systems n=150 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Percent of Participants With a Repeat Hospitalization for Aortic Valve Disease at 30 Days Post-procedure.	4.0 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 30 days

Population: Attempted Implant set

Rate of repeat hospitalization for ascending aorta disease at 30 days

Outcome measures

Measure	Medtronic TAVR Systems n=150 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Percent of Participants With a Repeat Hospitalization for Ascending Aorta Disease at 30 Days Post-procedure.	0.0 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 30 days

Population: Implanted set

Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

Outcome measures

Measure	Medtronic TAVR Systems n=148 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Hemodynamic Performance Metrics by Doppler Echocardiography: Mean Aortic Gradient Reported as Mean Average at Baseline and 30 Days Baseline	48.01 mmHg Standard Deviation 16.09
Hemodynamic Performance Metrics by Doppler Echocardiography: Mean Aortic Gradient Reported as Mean Average at Baseline and 30 Days 30 Day	7.58 mmHg Standard Deviation 3.69

SECONDARY outcome

Timeframe: 30 days

Population: Implanted set

Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.

Outcome measures

Measure	Medtronic TAVR Systems n=148 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Hemodynamic Performance Metrics by Doppler Echocardiography: Effective Orifice Area Reported as Mean Average at Baseline and 30 Days. Baseline	0.81 cm^2 Standard Deviation 0.23
Hemodynamic Performance Metrics by Doppler Echocardiography: Effective Orifice Area Reported as Mean Average at Baseline and 30 Days. 30 Day	2.28 cm^2 Standard Deviation 0.73

SECONDARY outcome

Timeframe: 30 days

Population: Implanted set

Reporting of prosthetic valve hemodynamic performance by degree of total prosthetic valve regurgitation at 30 days post-procedure

Outcome measures

Measure	Medtronic TAVR Systems n=148 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days Baseline: None	30.4 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days Baseline: Trace	24.3 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days Baseline: Mild/Mild to Moderate	42.6 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days Baseline: Moderate/Moderate to Severe	2.7 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days Baseline: Severe	0.0 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days Baseline: >=Moderate	2.7 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days 30 Day: None	34.2 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days 30 Day: Trace	25.3 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days 30 Day: Mild/Mild to Moderate	40.4 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days 30 Day: Moderate/Moderate to Severe	0.0 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days 30 Day: >=Moderate	0.0 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days 30 Day: Severe	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: Implanted set

Reporting of prosthetic valve hemodynamic performance by degree of paravalvular regurgitation at 30 days post-procedure

Outcome measures

Measure	Medtronic TAVR Systems n=148 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Paravalvular Prosthetic Regurgitation at 30 Days 30 Day: None	36.1 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Paravalvular Prosthetic Regurgitation at 30 Days 30 Day: Trace	23.6 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Paravalvular Prosthetic Regurgitation at 30 Days 30 Day: Mild/Mild to Moderate	40.3 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Paravalvular Prosthetic Regurgitation at 30 Days 30 Day: Moderate/Moderate to Severe	0.0 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Paravalvular Prosthetic Regurgitation at 30 Days 30 Day: Severe	0.0 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Paravalvular Prosthetic Regurgitation at 30 Days 30 Day: >=Moderate	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: Implanted set

Reporting of prosthetic valve hemodynamic performance by degree of transvalvular regurgitation at 30 days post-procedure

Outcome measures

Measure	Medtronic TAVR Systems n=148 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Transvalvular Prosthetic Regurgitation at 30 Days 30 Day: None	95.1 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Transvalvular Prosthetic Regurgitation at 30 Days 30 Day: Trace	4.9 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Transvalvular Prosthetic Regurgitation at 30 Days 30 Day: Mild/Mild to Moderate	0.0 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Transvalvular Prosthetic Regurgitation at 30 Days 30 Day: Moderate/Moderate to Severe	0.0 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Transvalvular Prosthetic Regurgitation at 30 Days 30 Day: Severe	0.0 Percentage of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Transvalvular Prosthetic Regurgitation at 30 Days 30 Day: >=Moderate	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: Attempted Implant set

Reporting of NYHA classification change from baseline to 30 days

NYHA Classification criteria:

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

Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.

Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.

Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.

Outcome measures

Measure	Medtronic TAVR Systems n=147 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
New York Heart Association (NYHA) Functional Classification at Baseline and 30 Days 30 day - Improved	121 Participants
New York Heart Association (NYHA) Functional Classification at Baseline and 30 Days 30 day - No Change	23 Participants
New York Heart Association (NYHA) Functional Classification at Baseline and 30 Days 30 day - Worsened	2 Participants
New York Heart Association (NYHA) Functional Classification at Baseline and 30 Days 30 day - Died	1 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Attempted Implant set

QoL overall summary (all domains below) and clinical summary (physical function and symptoms only) scores and change in summary scores from baseline using the following measures:

• KCCQ: Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Outcome measures

Measure	Medtronic TAVR Systems n=150 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days Baseline KCCQ - Overall	68.5 Score on a scale Standard Deviation 19.6
Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days Baseline KCCQ - Clinical	73.7 Score on a scale Standard Deviation 20.3
Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days 30 day KCCQ - Overall	90.3 Score on a scale Standard Deviation 12.8
Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days 30 day KCCQ - Clinical	91.3 Score on a scale Standard Deviation 12.5
Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days 30 day change from baseline KCCQ - Overall	21.6 Score on a scale Standard Deviation 17.6
Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days 30 day change from baseline KCCQ - Clinical	17.6 Score on a scale Standard Deviation 17.7

SECONDARY outcome

Timeframe: 30 days

Population: Attempted Implant set

QoL summary scores and change from baseline using the following measures:

• EQ-5D: Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state

Outcome measures

Measure	Medtronic TAVR Systems n=150 Participants Treatment with Medtronic Evolut PRO and Evolut R systems
Health-related Quality of Life (QoL) as Assessed by European QoL (EQ-5D) at Baseline and 30 Days. Baseline EQ-5D Index Score	0.8 Score on a scale Standard Deviation 0.1
Health-related Quality of Life (QoL) as Assessed by European QoL (EQ-5D) at Baseline and 30 Days. 30 day EQ-5D Index Score	0.9 Score on a scale Standard Deviation 0.1
Health-related Quality of Life (QoL) as Assessed by European QoL (EQ-5D) at Baseline and 30 Days. 30 day change from baseline EQ-5D Index Score	0.1 Score on a scale Standard Deviation 0.1

Adverse Events

Medtronic TAVR Systems

Serious events: 57 serious events

Other events: 120 other events

Deaths: 1 deaths

Serious adverse events

Measure	Medtronic TAVR Systems n=150 participants at risk Treatment with Medtronic Evolut PRO and Evolut R systems
Blood and lymphatic system disorders Anemia	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Blood and lymphatic system disorders Heparin-Induced Thrombocytopenia	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Acute Myocardial Infarction	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Atrial Fibrillation	2.7% 4/150 • Number of events 4 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Atrial Flutter	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Atrioventricular Block	1.3% 2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Atrioventricular Block Complete	8.7% 13/150 • Number of events 13 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Atrioventricular Block Second Degree	1.3% 2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Bradycardia	1.3% 2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Bundle Branch Block Left	3.3% 5/150 • Number of events 5 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Bundle Branch Block Right	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Cardiac Failure Congestive	1.3% 2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Cardiomyopathy	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Conduction Disorder	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Coronary Artery Occlusion	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Mitral Valve Incompetence	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Pulseless Electrical Activity	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Sinus Bradycardia	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Tachycardia	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Congenital, familial and genetic disorders Hemangioma Congenital	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Eye disorders Retinal Artery Occlusion	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Eye disorders Visual Impairment	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Gastrointestinal disorders Gastrointestinal Hemorrhage	1.3% 2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
General disorders Chest Discomfort	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
General disorders Chest Pain	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
General disorders Device Embolization	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
General disorders Non-Cardiac Chest Pain	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Hepatobiliary disorders Cholecystitis	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Infections and infestations Pneumonia Klebsiella	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Infections and infestations Respiratory Tract Infection	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Infections and infestations Urinary Tract Infection	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Injury, poisoning and procedural complications Device Deployment Issue	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Injury, poisoning and procedural complications Vascular Access Site Complication	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Metabolism and nutrition disorders Fluid Overload	1.3% 2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Metabolism and nutrition disorders Hypocalcemia	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Metabolism and nutrition disorders Hypokalemia	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Nervous system disorders Cerebrovascular Accident	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Nervous system disorders Embolic Stroke	1.3% 2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Nervous system disorders Headache	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Nervous system disorders Presyncope	1.3% 2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Nervous system disorders Syncope	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Nervous system disorders Transient Ischaemic Attack	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Product Issues Device Leakage	2.7% 4/150 • Number of events 4 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Product Issues Device Malfunction	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Reproductive system and breast disorders Acute Pulmonary Edema	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Reproductive system and breast disorders Acute Respiratory Failure	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Vascular disorders Deep Vein Thrombosis	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Vascular disorders Femoral Artery Dissection	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Vascular disorders Hypotension	4.7% 7/150 • Number of events 7 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Vascular disorders Peripheral Artery Stenosis	0.67% 1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.

Other adverse events

Measure	Medtronic TAVR Systems n=150 participants at risk Treatment with Medtronic Evolut PRO and Evolut R systems
Blood and lymphatic system disorders Anemia	6.7% 10/150 • Number of events 10 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Blood and lymphatic system disorders Thrombocytopenia	8.7% 13/150 • Number of events 13 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Atrioventricular Block First Degree	12.0% 18/150 • Number of events 19 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Bundle Branch Block Left	34.0% 51/150 • Number of events 51 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Cardiac disorders Bundle Branch Block Right	6.0% 9/150 • Number of events 9 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Injury, poisoning and procedural complications Anemia Postoperative	5.3% 8/150 • Number of events 8 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Vascular disorders Hypertension	7.3% 11/150 • Number of events 11 • Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure. All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.

Additional Information

Hatice Bilgic Lim, PhD; Principal Clinical Research Specialist

Medtronic Coronary and Structural Heart Clinical

Phone: 763-526-1018

Email: hatice.bilgic.lim@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