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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Transfemoral mitral-valve repair
Structral Heart Disease Center, Fuwai Hospital
Beijing, Beijing Municipality, China
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
Time frame: 12 months after Transfemoral mitral-valve repair
rehospitalization
The rate of rehospitalization due to heart failure
Time frame: 30 days,6 months,12months after Transfemoral mitral-valve repair
postoperative
The rate of postoperative mitral regurgitation (MR ≤ 2+)
Time frame: 30 days,6 months,12months after Transfemoral mitral-valve repair
New York Heart Association (NYHA)
The rate of New York Heart Association (NYHA) Function Class I or II.
Time frame: 30 days,6 months,12months after Transfemoral mitral-valve repair
walk test
Change in 6-minutes walk test distance.
Time frame: 12 months after Transfemoral mitral-valve repair
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Improvement value of quality of life changes assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 12 months after Transfemoral mitral-valve repair
left ventricular end diastolic volume (LVEDV)
Echocardiographic changes in left ventricular end diastolic volume (LVEDV) from
Time frame: 12 months after Transfemoral mitral-valve repair
procedural success
Acute procedural success
Time frame: Before discharge
device success
Acute device success
Time frame: Immediately after procedure
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