Severe Mitral Valve Regurgitation (Disorder) Clinical Trial
Official title:
Transcatheter Edge to Edge Mitral Valve Repair Versus Standard Surgical Mitral Valve Operation for Secondadry Mitral Regurgitation
The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER). The key question of this study is to establish the difference in left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-systolic dimension(LVESD), all-cause and cause-specific (cardiac vs noncardiac) mortality in patients who received the TEER vs the standard surgical procedure for SMR.
The target population enrolled in the registry includes patients with moderate to severe secondary mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology who have had TEER or standard surgical procedure of their mitral valves with or without CABG. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, mitral regurgitation, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV. Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement and recipients of mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair. Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement, and those who received mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair ;