The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR

Conditions studied

Cardiovascular Diseases, Functional Mitral Regurgitation, Heart Diseases, Heart Failure, Heart Valve Diseases, Mitral Valve Insufficiency

What is being tested

• DEVICE: Carillon Mitral Contour System
• OTHER: Guideline Directed Heart Failure Medication

What it measures

• 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.), 24 months
• 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%., 12 months