A randomized double-blind trial of an interventional device treatment of functional mitral regurgitation in patients with symptomatic congestive heart failure—Trial design of the REDUCE FMR study
Why the study?
Does the Carillon Mitral Contour System reduce regurgitant volume in patients with symptomatic congestive heart failure and functional mitral regurgitation?
Population
Patients with symptomatic congestive heart failure and functional mitral regurgitation with suitable…
Comparison
Carillon Mitral Contour System vs No device (blinded)
Design
Other, 3:1 basis, double-blind (patients and assessors are blinded)
Follow-up
1 year
Authors
Discussion
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Member takes
Implication
RCT of Carillon system tests regurgitant volume reduction in HF with FMR; extends device evidence with randomized, blinded design.
Structured PICO
Does the Carillon Mitral Contour System reduce regurgitant volume in patients with symptomatic congestive heart failure and functional mitral regurgitation?
P
Population
Patients with symptomatic congestive heart failure and functional mitral regurgitation with suitable coronary sinus vein dimensions
I
Intervention
Carillon Mitral Contour System (coronary sinus-based indirect annuloplasty device)
C
Comparator
No device (blinded)
O
Outcome
Difference in regurgitant volume at 1 year between the implanted and nonimplanted groupssurrogate
The REDUCE FMR study is a randomized, double-blind trial designed to evaluate the efficacy of the Carillon Mitral Contour System in reducing regurgitant volume in patients with symptomatic heart failure and functional mitral regurgitation.
Cite This Study
Goldberg et al. (2017) studied this question.