The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).
Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity
NYHA II, III, or IV
Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
Left Ventricular Ejection Fraction ≤ 50%
Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture)
Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
Severe mitral annular calcification
Cardiac Dimensions, Inc.
Lead sponsor