To confirm the effectiveness and safety of the transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment.
1.Age ≥ 18 yrs；
2. Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy
3. Subjects have been adequately treated according to applicable criteria, including treatment for coronary artery disease, left ventricular dysfunction, mitral regurgitation, and heart failure (e.g., with cardiac resynchronization therapy (CRT or CRT-D), coronary revascularization, and/or have received stable GDMT, confirmed by the local heart team;
4. NYHA functional class II to IV;
1) Echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
2) The presence of other severe heart valve disease requiring surgical intervention.;
3) After mitral valve surgery or mitral valve transcatheter surgery;
4)Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis, etc.), or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.;
Single group
Transfemoral mitral-valve repair
DeviceTransfemoral mitral-valve repair
The composite endpoint of all-cause mortality and rehospitalization due to heart failure 12 months after Transfemoral mitral-valve repair
All-cause mortality and rehospitalization due to heart failure
rehospitalization
The rate of rehospitalization due to heart failure
postoperative
The rate of postoperative mitral regurgitation (MR ≤ 2+)
New York Heart Association (NYHA)
The rate of New York Heart Association (NYHA) Function Class I or II.
walk test
Change in 6-minutes walk test distance.
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Pan Xiangbin
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor institution
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