At a glance
ClinicalIndex Comparison RecordN/ACompleted· 191 enrolled
Drug / intervention
Tendyne Mitral 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.
Expanded Clinical Study of the Tendyne Mitral Valve System
In Brief
A clinical study evaluating Tendyne Mitral Valve System for Mitral Valve Regurgitation. Completed, enrolled 191 participants across 40 sites in 10 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Valve Regurgitation
CountriesAustralia, France, Germany, Italy, Netherlands, Norway, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
First PostedDec 2014
Primary CompletionJul 2020
Study CompletionApr 2025
TodayJul 2026
First PostedDec 22, 2014
Enrollment StartNov 1, 2014
Primary CompletionJul 1, 2020
Study CompletionApr 1, 2025
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 11.5 years ago
Interventions
Tendyne Mitral Valve Systemdevice
Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system