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

Inclusion Criteria:

1. Symptomatic heart failure with functional (secondary) mitral regurgitation of atleast 1+ (mild) severity

2. NYHA II, III, or IV

3. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters

4. Left Ventricular Ejection Fraction ≤ 50%

5. LVEDD ≥ 57 mm and LVESD ≤ 75 mm

6. Corrected BNP of > 300 pg/ml, or corrected NT-proBNP > 1200 pg/ml, or one or moreheart failure hospitalizations within one year prior to consent

7. Guideline directed heart failure medication regimen

8. Age 18 years old

9. Carillon implant can be sized and placed in accordance with the IFU

10. The subject has been informed of the nature of the trial and agrees to itsprovisions, including the possibility of randomization to the Control group andreturning for all required post-procedure follow-up visits, and has provided writteninformed consent

Exclusion Criteria:

1. Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV) or Class I indication for cardiac resynchronization therapy (CRT)

2. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valveannuloplasty, or leaflet repair device

3. Significant organic mitral valve pathology (e.g., moderate or severe myxomatousdegeneration, with or without mitral leaflet prolapse, rheumatic disease, full orpartial chordal rupture)

4. Severe tricuspid regurgitation associated with right ventricular dysfunction andenlargement

5. Severe mitral annular calcification

6. Severe aortic stenosis

7. Expected to require any cardiac surgery, including surgery for coronary arterydisease (CAD) or valve disease within one (1) year

8. Chronic, severe, medical conditions or pathology, other than heart failure, thatwill prevent likely survival beyond twelve (12) months or any other medicalcondition that, in the judgment of the Investigator, makes the patient a poorcandidate for this study

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