At a glance
ClinicalIndex Comparison RecordN/ACompleted· 60 enrolled
Drug / intervention
The CoreValve™ Evolut R TAV™ 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.
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
In Brief
A clinical study evaluating The CoreValve™ Evolut R TAV™ system for Aortic Stenosis. Completed, enrolled 60 participants across 6 sites in 3 countries.
Detailed Summary
To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Stenosis
CountriesAustralia, New Zealand, United Kingdom
CollaboratorsMedtronic
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 2013
Enrollment StartOct 2013
Primary CompletionAug 2014
Study CompletionOct 2016
TodayJul 2026
First PostedJun 12, 2013
Enrollment StartOct 1, 2013
Primary CompletionAug 1, 2014
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.1 years ago
Interventions
The CoreValve™ Evolut R TAV™ systemdevice
CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 \& 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System