Evaluation of Outcomes of CRT and MitraClip for Treatment of Low Ejection Fraction and Functional Mitral Regurgitation in HF

Exclusion Criteria

• •1. Life expectancy less than 12 months due to noncardiac conditions;
• •2. ACC/AHA Stage D Heart Failure;
• •3. Left ventricular ejection fraction ≤ 15%;
• •4. Hypotension (systolic pressure \<90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support;
• •5. United Network for Organ Sharing (UNOS) status 1 heart transplantation or prior orthotopic heart transplantation;
• •6. Untreated clinically significant coronary artery disease requiring revascularization;
• •7. CABG within prior 30 days;
• •8. Percutaneous coronary intervention within prior 30 days;
• •9. Severe Chronic Obstructive Pulmonary Disease (COPD) requiring continuous daytime home oxygen or chronic oral corticosteroid therapy;
• •10. Previous surgical mitral valve bioprosthesis, mitral annuloplasty, or transcatheter mitral valve procedure;
• •11. Positive pregnancy test, or woman of child bearing potential not using highly effective methods of contraception;
• •12. Mitral valve area \<4.0 cm2 as assessed by planimetry of the mitral valve;
• •13. Subjects in whom trans-esophageal echocardiography is contraindicated or high risk;
• •14. Mitral leaflet anatomy which may preclude MitraClip implantation:
• •1. Perforated mitral leaflets or clefts, lack of primary or secondary chordal support;
• •2. Severe calcification in the grasping area;
• •3. Rheumatic valve disease.
• •15. Previously implanted Cardiac Resynchronization Therapy and Defibrillator (CRT-D) system;
• •16. Stroke or transient ischemic event within 30 days before randomization;
• •17. Modified Rankin Scale \>4 disability;
• •18. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months;
• •19. Severe renal impairment defined as an Estimated Glomerular Filtration Rate (eGFR) \<30 mL/min/1.73m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula;
• •20. Severe anemia requiring transfusional support or therapy with erythropoietin;
• •21. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction;
• •22. Aortic valve disease requiring surgery or transcatheter intervention;
• •23. Significant tricuspid valve disease requiring surgical intervention or very severe tricuspid regurgitation;
• •24. Active infection requiring antibiotic therapy;
• •25. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease;
• •26. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
• •27. Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits;
• •28. Presence of any of the following:
• •1. Pulmonary artery systolic pressure (PASP) \> 70 mm Hg confirmed by right heart catheterization;
• •2. Infiltrative cardiomyopathies.
• •29. Any other condition(s) that would compromise the safety of the patient as judged by the site principal investigator.