Trial Outcomes & Findings for Medtronic Evolut™ EXPAND TAVR I Feasibility Study (NCT NCT04639258)

NCT ID: NCT04639258

Last Updated: 2024-01-10

Results Overview

Rate of all-cause and cardiovascular mortality

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2024-01-10

Participant Flow

Participant milestones

Measure	TAVR Up to 75 subjects with moderate, symptomatic AS
Overall Study STARTED	11
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	TAVR Up to 75 subjects with moderate, symptomatic AS
Overall Study Screen failure	5
Overall Study Physician Decision	2
Overall Study Early study termination	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

STS score was reported for 6 participants

Baseline characteristics by cohort

Measure	TAVR n=8 Participants Up to 75 subjects with moderate, symptomatic AS with an attempted TAVR procedure
Age, Continuous	76.9 years n=8 Participants
Sex: Female, Male Female	4 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=8 Participants
Race (NIH/OMB) White	8 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants
Region of Enrollment New Zealand	2 participants n=8 Participants
Region of Enrollment United States	3 participants n=8 Participants
Region of Enrollment Australia	3 participants n=8 Participants
NYHA Classification Class I	5 Participants n=8 Participants
NYHA Classification Class II	0 Participants n=8 Participants
NYHA Classification Class III	0 Participants n=8 Participants
NYHA Classification Class IV	0 Participants n=8 Participants
NYHA Classification Unknown/Not Reported	3 Participants n=8 Participants
Society of Thoracic Surgeons (STS) Score	2.9 Percentage n=6 Participants • STS score was reported for 6 participants
BSA	1.7 m^2 n=8 Participants • Body surface area was reported for 6 participants.

PRIMARY outcome

Timeframe: 30 days

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of all-cause and cardiovascular mortality

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of all-cause and cardiovascular mortality

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of disabling and non-disabling stroke

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of disabling and non-disabling stroke

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of periprocedural and spontaneous myocardial infarction

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of periprocedural and spontaneous myocardial infarction

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: No subjects with an attempted TAVR procedure No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of acute kidney injury

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of acute kidney injury

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of major vascular complications

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of major vascular complications

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of life-threatening (or disabling) bleed

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of life-threatening (or disabling) bleed

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Rate of valve-related dysfunction requiring repeat procedure

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Rate of valve-related dysfunction requiring repeat procedure

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Discharge (12 hours to 7 days post-procedure)

Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

The VARC-2 definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, 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 <3 m/sec), and absence of moderate or severe prosthetic valve regurgitation

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of cardiovascular and heart failure hospitalizations

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of cardiovascular and heart failure hospitalizations

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of heart failure events

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of heart failure events

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Discharge (12 hours to 7 days post-procedure)

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Discharge (12 hours to 7 days post-procedure)

Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Discharge (12 hours to 7 days post-procedure)

Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Discharge (12 hours to 7 days post-procedure)

Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days and 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Reporting of NYHA classification change from baseline to 30 days and 6 months

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

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Reporting change from baseline in distance walked during 6MWT

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days and 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Reporting of change in GLS from baseline by echocardiography

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Reporting of change in left ventricular filling pressure (E:e') from baseline by echocardiography

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Reporting of change in stroke volume index (SVI) from baseline by echocardiography

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Reporting of change in NT-pro B-type natriuretic peptide (NT-proBNP) from baseline

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Annually through 5 years

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of all-cause and cardiovascular mortality

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Annually through 5 years

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of disabling and non-disabling strokes

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Annually through 5 years

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of cardiovascular and heart failure hospitalizations

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Annually through 5 years

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Rate of heart failure events

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days, 6 months, and annually through 5 years

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Reporting NYHA functional classification by timepoint following attempted procedure

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Annually through 5 years

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

Reporting of NYHA classification change from baseline to 30 days and 6 months

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

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Annually through 5 years

Population: No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for: * Attempted Implant (all subjects with an attempted procedure) * Implanted (all subjects with an attempted procedure where the study device is implanted)

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Annually through 5 years

Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Annually through 5 years

Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Reporting of prosthetic valve hemodynamic performance by effective orifice area (EOA)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Annually through 5 years

Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular prosthetic regurgitation by Doppler echocardiography

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Annually through 5 years

Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days, 6 months, and annually through 5 years

Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Rate of prosthetic valve thrombosis

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days, 6 months, and annually through 5 years

Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Rate of prosthetic valve endocarditis

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days, 6 months, and annually through 5 years

Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Rate of bioprosthetic valve dysfunction (BVD)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days, 6 months, and annually through 5 years

Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Rate of bioprosthetic valve failure (BVF)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Annually through 5 years

Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.

Rate of valve-related dysfunction requiring repeat procedure

Outcome measures

Outcome data not reported

Adverse Events

TAVR

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	TAVR n=11 participants at risk Up to 75 subjects with moderate, symptomatic AS with an attempted TAVR procedure
Cardiac disorders Coronary stenosis	9.1% 1/11 • Number of events 1 • Adverse events (AEs) were collected from study enrollment (consent) through study exit, up to 151 days. First subject was enrolled on 28 May 2021 and last subject was exited on 28 Feb 2022. No study subjects were treated. If subjects had been treated all AEs would have been reported through 6 months post-procedure. After 6 months post-procedures only serious adverse events, device-related events, and device deficiencies would have been reported. The definitions used for AEs and SAEs is too long for the field. The definitions differed in that the CIP used the definitions found in ISO14100:2020. Investigators are required to evaluate and document in the subject's medical records all adverse events and device deficiencies observed in study subjects from the time they are enrolled until they are exited from the study. All AEs should be followed through their resolution.
Injury, poisoning and procedural complications Left radial artery pseudoaneurysm following study specific angiogram	9.1% 1/11 • Number of events 1 • Adverse events (AEs) were collected from study enrollment (consent) through study exit, up to 151 days. First subject was enrolled on 28 May 2021 and last subject was exited on 28 Feb 2022. No study subjects were treated. If subjects had been treated all AEs would have been reported through 6 months post-procedure. After 6 months post-procedures only serious adverse events, device-related events, and device deficiencies would have been reported. The definitions used for AEs and SAEs is too long for the field. The definitions differed in that the CIP used the definitions found in ISO14100:2020. Investigators are required to evaluate and document in the subject's medical records all adverse events and device deficiencies observed in study subjects from the time they are enrolled until they are exited from the study. All AEs should be followed through their resolution.
Vascular disorders Haematome, left radial	9.1% 1/11 • Number of events 1 • Adverse events (AEs) were collected from study enrollment (consent) through study exit, up to 151 days. First subject was enrolled on 28 May 2021 and last subject was exited on 28 Feb 2022. No study subjects were treated. If subjects had been treated all AEs would have been reported through 6 months post-procedure. After 6 months post-procedures only serious adverse events, device-related events, and device deficiencies would have been reported. The definitions used for AEs and SAEs is too long for the field. The definitions differed in that the CIP used the definitions found in ISO14100:2020. Investigators are required to evaluate and document in the subject's medical records all adverse events and device deficiencies observed in study subjects from the time they are enrolled until they are exited from the study. All AEs should be followed through their resolution.

Other adverse events

Measure	TAVR n=11 participants at risk Up to 75 subjects with moderate, symptomatic AS with an attempted TAVR procedure
Injury, poisoning and procedural complications Scalp laceration	9.1% 1/11 • Number of events 1 • Adverse events (AEs) were collected from study enrollment (consent) through study exit, up to 151 days. First subject was enrolled on 28 May 2021 and last subject was exited on 28 Feb 2022. No study subjects were treated. If subjects had been treated all AEs would have been reported through 6 months post-procedure. After 6 months post-procedures only serious adverse events, device-related events, and device deficiencies would have been reported. The definitions used for AEs and SAEs is too long for the field. The definitions differed in that the CIP used the definitions found in ISO14100:2020. Investigators are required to evaluate and document in the subject's medical records all adverse events and device deficiencies observed in study subjects from the time they are enrolled until they are exited from the study. All AEs should be followed through their resolution.
Nervous system disorders Parasthesia, left thumb and index finger	9.1% 1/11 • Number of events 1 • Adverse events (AEs) were collected from study enrollment (consent) through study exit, up to 151 days. First subject was enrolled on 28 May 2021 and last subject was exited on 28 Feb 2022. No study subjects were treated. If subjects had been treated all AEs would have been reported through 6 months post-procedure. After 6 months post-procedures only serious adverse events, device-related events, and device deficiencies would have been reported. The definitions used for AEs and SAEs is too long for the field. The definitions differed in that the CIP used the definitions found in ISO14100:2020. Investigators are required to evaluate and document in the subject's medical records all adverse events and device deficiencies observed in study subjects from the time they are enrolled until they are exited from the study. All AEs should be followed through their resolution.
Reproductive system and breast disorders Bilateral ovarian cysts	9.1% 1/11 • Number of events 1 • Adverse events (AEs) were collected from study enrollment (consent) through study exit, up to 151 days. First subject was enrolled on 28 May 2021 and last subject was exited on 28 Feb 2022. No study subjects were treated. If subjects had been treated all AEs would have been reported through 6 months post-procedure. After 6 months post-procedures only serious adverse events, device-related events, and device deficiencies would have been reported. The definitions used for AEs and SAEs is too long for the field. The definitions differed in that the CIP used the definitions found in ISO14100:2020. Investigators are required to evaluate and document in the subject's medical records all adverse events and device deficiencies observed in study subjects from the time they are enrolled until they are exited from the study. All AEs should be followed through their resolution.
Vascular disorders Saccular infrarenal abdominal aortic aneurysm	9.1% 1/11 • Number of events 1 • Adverse events (AEs) were collected from study enrollment (consent) through study exit, up to 151 days. First subject was enrolled on 28 May 2021 and last subject was exited on 28 Feb 2022. No study subjects were treated. If subjects had been treated all AEs would have been reported through 6 months post-procedure. After 6 months post-procedures only serious adverse events, device-related events, and device deficiencies would have been reported. The definitions used for AEs and SAEs is too long for the field. The definitions differed in that the CIP used the definitions found in ISO14100:2020. Investigators are required to evaluate and document in the subject's medical records all adverse events and device deficiencies observed in study subjects from the time they are enrolled until they are exited from the study. All AEs should be followed through their resolution.

Additional Information

Robert Waltonen

Medtronic Structural Heart & Aortic

Phone: 763-526-0424

Email: robert.waltonen@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