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
Parallel
Carillon Mitral Contour System
DeviceThe Carillon implant is designed to be deployed, tensioned, and locked in the coronary vein in order to reshape the mitral annulus and thus reduce mitral annular dilation and mitral regurgitation.
Guideline Directed Heart Failure Medication
Other interventionHeart failure medication per ACC/AHA guidelines
Primary Safety Objective - Freedom from Major Adverse Events
Freedom from a composite of major adverse events (defined as Device Embolization, Vessel Erosion, Cardiac Perforation, and occurrence of cardiac surgery or percutaneous coronary intervention) in the Intervention group is greater than performance goal of 90%.
Primary Efficacy Objective 1 - Hierarchical Clinical Composite
To demonstrate that the CMCS (Intervention) group is superior to the Control group on the hierarchical composite endpoint of death, Cardiac transplantation or LVAD implantation, unplanned percutaneous or surgical mitral valve intervention, unplanned heart failure hospitalization, change in KCCQ overall summary score, and change in six-minute walk distance at 24 months (analyzed when the last subject completes 12 months of follow-up.)
Secondary Efficacy Objective 1- Regurgitant Volume
To compare regurgitant volume change relative to control from baseline through 12 months of follow up in patients with at least MR grade 2+ at baseline
Secondary Efficacy Objective 2 - Change in LV End-diastolic Volume
To compare the change from baseline left ventricular end-diastolic volume (LVEDV) relative to the Control group.
Secondary Efficacy Objective 3 - Change in NYHA
To compare the change from baseline in New York Heart Association (NYHA) Classification, relative to Control, at twelve (12) months
Secondary Efficacy Objective 4 - Hierarchical Clinical Composite
To compare the first four components of the hierarchical primary efficacy endpoint, relative to Control, analyzed when the last subject completes 12 months of follow up and use all available data up to twenty-four (24) months
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