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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.
Full description
This study is a prospective, multicenter, objective performance criteria clinical design.Patients are moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment. All subjects receive clinical follow-up immediately after procedure, before discharge, 30 days after procedure, 6 months after transfemoral mitral-valve repair, 12 months and 2 yeas,3 years,4 years after Transfemoral mitral-valve repair.
The primary outcome is defined as all-cause death and rehospitalization due to heart failure 12 months after Transfemoral mitral-valve repair.
The secondary outcomes include:Rate of rehospitalization due to heart failure after operation;Rate of postoperative mitral regurgitation (MR ≤ 2+);Rate of New York Heart Association (NYHA) Function Class I or II after Transfemoral mitral-valve repair;Change in 6 minutes walk test distance;Improvement value of quality of life changes assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ);Echocardiographic changes in left ventricular end diastolic volume (LVEDV) from baseline;Acute procedural success,Acute device success.
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Inclusion criteria
Note 1: Functional MR requires the presence of overall or localized left ventricular wall motion abnormalities that are considered to be the primary cause of MR. Despite the eligibility, subjects may not enroll if leaflet prolapse or other evidence of degenerative MR is present.
Note 2: An Eligible transthoracic echocardiography must be obtained at least 30 days after the subject has been stabilized on optimal therapy with Guideline Directed Medical Therapy (GDMT), or at least 30 days under the following conditions after meeting two of the following conditions:Coronary revascularization and/or implantation of a cardiac resynchronization therapy device (CRT-P or CRT-D) or reprogramming of the implanted CRT-P or CRT-D resulting in an increase in biventricular pacing (from <92% to ≥92%).
Exclusion criteria
Note: Women of childbearing age should take a pregnancy test with a negative result within 14 days prior to registration and use scientifically safe contraception;
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140 participants in 1 patient group
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Central trial contact
Yueyan li
Data sourced from clinicaltrials.gov
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