CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,777 enrolled
Drug / intervention
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)device
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/NCT01531374
NCT01531374N/ACompleted
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Medtronic CoreValve® Continued Access Study

Medtronic Cardiovascular·interventional·Posted Feb 10, 2012·Updated Oct 25, 2022

In Brief

A clinical study evaluating Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) for Severe Aortic Stenosis. Completed, enrolled 2,777 participants across 45 sites.

Detailed Summary

The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted very high risk and high risk for aortic valve surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Aortic Stenosis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2012
Enrollment StartFeb 21, 2012
Primary CompletionNov 1, 2015
Study CompletionNov 18, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 14.4 years ago

Interventions

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)device