At a glance
ClinicalIndex Comparison RecordN/ACompleted· 250 enrolled
Drug / intervention
Lotus Valve 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.
REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance
In Brief
A clinical study evaluating Lotus Valve System for Transcatheter Aortic Valve Replacement. Completed, enrolled 250 participants across 20 sites in 9 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTranscatheter Aortic Valve Replacement
CountriesAustralia, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartOct 2012
Primary CompletionMay 2014
Study CompletionMay 2019
TodayJul 2026
First PostedJun 26, 2012
Enrollment StartOct 8, 2012
Primary CompletionMay 30, 2014
Study CompletionMay 13, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.0 years ago
Interventions
Lotus Valve Systemdevice
* bioprosthetic bovine pericardial aortic valve * delivery system