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

This is an interventional treatment trial for Functional Mitral Regurgitation focused on measuring Functional Mitral Regurgitation, Percutaneous Mitral Valve Repair, Percutaneous Mitral Valve Annuloplasty, Coronary Sinus Annuloplasty, Secondary Mitral Regurgitation, Functional MR, FMR Read More

Inclusion Criteria:

1. Diagnosis of ischemic or non-ischemic cardiomyopathy
2. 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.
3. NYHA Class II, III, or IVa
4. Six Minute Walk distance ≥ 150 meters and ≤ 450 meters
5. Left Ventricular Ejection Fraction ≤ 50%
6. LVEDD ≥ 60 mm and LVESD ≤ 70 mm Note: As assessed by Imaging Core Laboratory.
7. 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
8. Guideline directed heart failure medication regimen.
9. Age ≥ 18 years old
10. CARILLON implant can be sized and placed in accordance with the IFU
11. 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

Exclusion Criteria:

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. Unlikely to benefit from annular reduction therapy
8. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
9. Hypertrophic cardiomyopathy, infiltrative cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
10. Echocardiographic documentation of non-compaction cardiomyopathy as assessed by the Imaging Core Laboratory
11. Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV)
12. 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
13. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory
14. Severe mitral annular calcification
15. Severe aortic stenosis
16. Not a candidate for right internal jugular venous cannulation
17. Hospitalization in past 30 days due to myocardial infarction, coronary artery bypass graft surgery or unstable angina
18. Cerebral vascular event within the past 30 days
19. Hospitalization in the past 30 days for coronary angioplasty or stent placement or ICD implant
20. Pulmonary embolus or deep vein thrombosis within the past six (6) months
21. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
22. Expected to require any percutaneous coronary intervention within 30 days of the index procedure.
23. 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
24. Presence of left atrial appendage (LAA) clot or presence of LAA occluder
25. Anemia defined as hemoglobin < 9.0 mg/dL
26. 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
27. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
28. Active infections requiring current antibiotic therapy
29. Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months
30. Female subjects pregnant or planning to become pregnant in the next five (5) years
31. Subjects unable to perform the required study assessments (e.g., 6 minute walk test)
32. Any other medical condition that, in the judgment of the Investigator, makes the patient a poor candidate for this study
33. 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