At a glance

ClinicalIndex Comparison Record

N/AActive· 2,223 enrolled

Drug / intervention

Medtronic Transcatheter Aortic Valve Replacement Systems +1 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02701283

NCT02701283N/AActive

Compare CT.gov

Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

Medtronic Cardiovascular·interventional·Posted Mar 8, 2016·Updated May 7, 2026

In Brief

A clinical study evaluating Medtronic Transcatheter Aortic Valve Replacement Systems and Surgical Aortic Valve Replacement (SAVR) for Aortic Valve Stenosis. Active but no longer recruiting, targeting 2,223 participants across 87 sites in 7 countries.

Detailed Summary

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAortic Valve Stenosis

CountriesAustralia, Canada, France, Japan, Netherlands, New Zealand, United States

Collaborators--

Timeline

N/AActive

20162017201820192020202120222023202420252026202720282029

Enrollment StartMar 2016

First PostedMar 2016

Primary CompletionApr 2021

TodayJul 2026

Study CompletionJun 2029

First PostedMar 8, 2016

Enrollment StartMar 1, 2016

Primary CompletionApr 1, 2021

Study CompletionJun 1, 2029

TodayJul 2, 2026

Enrollment to primary: 5.1 yearsPosted 10.3 years ago

Interventions

Medtronic Transcatheter Aortic Valve Replacement Systemsdevice

Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems

Surgical Aortic Valve Replacement (SAVR)device

Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis