CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,060 enrolled
Drug / intervention
Medtronic CoreValve™ Evolut R™ 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/NCT02592369
NCT02592369N/ACompleted
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The Medtronic CoreValve™ Evolut R™ FORWARD Study

Medtronic Cardiovascular·observational·Posted Oct 30, 2015·Updated Apr 30, 2020

In Brief

An observational study evaluating Medtronic CoreValve™ Evolut R™ System for Aortic Valve Stenosis. Completed, enrolled 1,060 participants across 54 sites in 21 countries.

Detailed Summary

Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis
CountriesAustralia, Belgium, Canada, Colombia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Norway, Panama, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 30, 2015
Enrollment StartJan 1, 2016
Primary CompletionFeb 1, 2017
Study CompletionFeb 6, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.7 years ago

Interventions

Medtronic CoreValve™ Evolut R™ Systemdevice

The Evolut R System is intended for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, to be at high or extreme risk for open heart surgery. The Evolut R TAV treats aortic stenosis by displacing and functionally replacing the dysfunctional native valve with a bioprosthetic valve delivered on a catheter while the heart is still beating, thus avoiding the risks of cardiopulmonary bypass. Its intended performance is to relieve aortic valve stenosis without inducing significant regurgitation, thereby restoring effective aortic valve function.