CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
CoreValve Evolut 34R TAVR systemdevice
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/NCT02746809
NCT02746809N/ACompleted
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Medtronic CoreValve Evolut R United States Clinical Study (Evolut 34R Addendum)

Medtronic Cardiovascular·interventional·Posted Apr 21, 2016·Updated May 3, 2023

In Brief

A clinical study evaluating CoreValve Evolut 34R TAVR system for Aortic Valve Stenosis. Completed, enrolled 72 participants across 10 sites.

Detailed Summary

The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme risk for surgical aortic valve replacement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 21, 2016
Enrollment StartJun 1, 2016
Primary CompletionNov 1, 2016
Study CompletionDec 15, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.2 years ago

Interventions

CoreValve Evolut 34R TAVR systemdevice

The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components: 1. Evolut 34R Transcatheter Aortic Valve (TAV) 2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath 3. EnVeo R Loading System (LS)