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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transfemoral mitral-valve repair | Device | Transfemoral mitral-valve repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months after Transfemoral mitral-valve repair |
| Measure | Description | Time Frame |
|---|---|---|
| rehospitalization | The rate of rehospitalization due to heart failure | 30 days,6 months,12months after Transfemoral mitral-valve repair |
| postoperative | The rate of postoperative mitral regurgitation (MR ≤ 2+) |
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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 contraceptionï¼›
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yueyan li | Contact | +86 15189109112 | yyli@kokalife.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiangbin Pan, MD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Structral Heart Disease Center, Fuwai Hospital | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41614293 | Derived | Li H, Chen Y, Zhang J, Guo Y, Guo Q, Guo H, Gong J, Ni D, Wang F, Xue W, Duan F. TEERAI-Pre: A Multiview Artificial Intelligence Model for Preoperative Assessment of Transcatheter Edge-to-Edge Mitral Valve Repair Using Multiview, Multimodal Echocardiography. J Am Heart Assoc. 2026 Feb 3;15(3):e044333. doi: 10.1161/JAHA.125.044333. Epub 2026 Jan 30. |
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| 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. | 30 days,6 months,12months after Transfemoral mitral-valve repair |
| walk test | Change in 6-minutes walk test distance. | 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) | 12 months after Transfemoral mitral-valve repair |
| left ventricular end diastolic volume (LVEDV) | Echocardiographic changes in left ventricular end diastolic volume (LVEDV) from | 12 months after Transfemoral mitral-valve repair |
| procedural success | Acute procedural success | Before discharge |
| device success | Acute device success | Immediately after procedure |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D006349 | Heart Valve Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
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