The CARILLON Trial - Assessment of the Carillon® Mitral Contour System® in Treating Functional Mitral Regurgitation Associated With Heart Failure

Open to people ages 18 years and up

1. Diagnosis of ischemic or non-ischemic cardiomyopathy
2. Symptomatic functional (secondary) mitral regurgitation defined as both: - 2+ (Moderate), 3+ (Moderate/Severe), or 4+ (Severe).

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.

1. NYHA Class II, III, or IV
2. Six Minute Walk distance ≥ 150 meters and ≤ 450 meters
3. Left Ventricular Ejection Fraction ≤ 50%
4. LVESD ≤ 70 mm Note: As assessed by Imaging Core Laboratory.
5. Corrected BNP of > 300 pg/ml, or corrected NT-proBNP > 1500 pg/ml, or one or more heart failure hospitalizations within one year prior to consent
6. Guideline directed heart failure medication regimen.
7. Age ≥ 18 years old
8. . CARILLON implant can be sized and placed in accordance with the IFU
9. . The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent

1. Recipient of intravenous positive-inotrope infusion or intra-aortic balloon pump support within the past 30 days
2. Heart failure hospitalization within the past 30 days
3. Anticipated need of left ventricular assist device within twelve (12) months
4. Class I indication for cardiac resynchronization therapy (CRT), or anticipated need for CRT within twelve (12) months
5. Primary renal dysfunction or compromised renal function as reflected by an estimated Glomerular Filtration Rate (eGFR) < 30 ml/min, as assessed by MDRD formula, or patients on dialysis
6. Heart transplant candidate or prior orthotopic heart transplantation
7. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device.
8. Hypertrophic cardiomyopathy, infiltrative cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
9. Echocardiographic documentation of non-compaction cardiomyopathy as assessed by the Imaging Core Laboratory
10. . Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV)
11. . 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
12. . Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory
13. . Severe mitral annular calcification
14. . Severe aortic stenosis
15. . Not a candidate for right internal jugular venous cannulation
16. . Hospitalization in past 30 days due to myocardial infarction, coronary artery bypass graft surgery or unstable angina
17. . Cerebral vascular event within the past 30 days
18. . Hospitalization in the past 30 days for coronary angioplasty or stent placement or ICD implant
19. . Pulmonary embolus or deep vein thrombosis within the past six (6) months
20. . Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
21. . Expected to require any percutaneous coronary intervention within 30 days of the index procedure.
22. . Hemodynamic instability defined as sustained systolic blood pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device
23. . Presence of left atrial appendage (LAA) clot or presence of LAA occluder
24. . Anemia defined as hemoglobin < 9.0 mg/dL
25. . Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
26. . Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
27. . Active infections requiring current antibiotic therapy
28. . Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months
29. . Female subjects pregnant or planning to become pregnant in the next five (5) years
30. . Subjects unable to perform the required study assessments (e.g., 6 minute walk test)
31. . Any other medical condition that, in the judgment of the Investigator, makes the patient a poor candidate for this study
32. . Subjects belonging to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or comply with the study procedures