At a glance
ClinicalIndex Comparison RecordN/ACompleted· 163 enrolled
Drug / intervention
Carillon Mitral Contour 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 REDUCE FMR Trial: Safety and Efficacy of the Carillon Mitral Contour System® in Reducing Functional Mitral Regurgitation (FMR) Associated With Heart Failure
In Brief
A clinical study evaluating Carillon Mitral Contour System for Mitral Valve Insufficiency and Heart Failure. Completed, enrolled 163 participants across 31 sites in 8 countries.
Detailed Summary
The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized Control group which is medically managed according to heart failure guidelines.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Valve Insufficiency, Heart Failure
CountriesAustralia, Czechia, France, Germany, Netherlands, New Zealand, Poland, United Kingdom
CollaboratorsMenzies Institute for Medical Research
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2014
Enrollment StartAug 2015
Primary CompletionJul 2018
Study CompletionJan 2020
TodayJul 2026
First PostedDec 25, 2014
Enrollment StartAug 22, 2015
Primary CompletionJul 1, 2018
Study CompletionJan 8, 2020
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.5 years ago
Interventions
Carillon Mitral Contour Systemdevice
Percutaneous mitral valve repair