The EMPOWER Trial – The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

Inclusion Criteria:

Diagnosis of ischemic or non-ischemic cardiomyopathy
Symptomatic functional (secondary) mitral regurgitation of at least 1+ (Mild) severity Note: 4+ can only be included if multidisciplinary site assessment (including a surgeon) determines that surgery is not necessary within the 1-year follow-up period for this study.
NYHA Class II, III, or IV
Six Minute Walk distance ≥ 150 meters and ≤ 450 meters
Left Ventricular Ejection Fraction ≤ 50%
LVEDD ≥ 60 mm and LVESD ≤ 70 mm
Corrected BNP of ≥ 300 pg/ml, or corrected NT-proBNP ≥ 1200 pg/ml, or one or more heart failure hospitalizations within six months prior to consent
Guideline directed heart failure medication regimen.

Exclusion Criteria:

Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV)
Class I indication for cardiac resynchronization therapy (CRT), or anticipated need for CRT within twelve (12) months
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), as assessed by the Imaging Core Laboratory
Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory
Severe mitral annular calcification
Severe aortic stenosis
Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
Presence of left atrial appendage (LAA) clot or presence of LAA occluder

Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months

An entire list of eligibility is available in the clinical investigational plan