Valveclip® Transcatheter Mitral Valve Repair Study

Study Overview
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Brief Summary
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The purpose of this clinical trial is to evaluate the effectiveness and safety of the transcatheter mitral valve repair system in the treatment of patients with moderate or above degenerative mitral regurgitation.

Detailed Description
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This study is a prospective,multi-center, single-arm, safety and performance clinical study.

Official Title
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Evaluation of the Efficacy and Safety of the Transcatheter Mitral Valve Repair System in Patients With Moderate and Above Degenerative Mitral Regurgitation at High Surgical Risk

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Device: Valveclip® Transcatheter mitral valve repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe mitral regurgitation≥3+ (moderate or above degenerative mitral regurgitation disease, or with stenosis is included); Age≥70 years; or patients who are 60 70 years old, and the STS risk score indicate that participants are at high risk of traditional surgery or cannot tolerate traditional thoracotomy; 4) Left ventricular ejection fraction≥30%； 5) As assessed by multidisciplinary cardiac team (at least two cardiac surgeons/one cardiologist), patients who are at extremely high-risk or unsuitable for routine mitral valve surgery with evaluation; 6) Patients who understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups. Anatomy selection Criteria： The regurgitant jet of mitral valve originates from the A2 and P2 (the lesions of A2/P2 in mitral valve causes regurgitation); The width of the mitral valve prolapsed area is ≤15mm, Height of Prolapse ≤10mm or coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets>1cm (conforming to EVEREST II recommended mitral valve interventional edge-to-edge repair standards); Effective mitral valve orifice area≥ 4.0cm2; No obvious calcification of the mitral valve annulus and valve leaflets; Patient's anatomical conditions allow transseptal approach. Exclusion Criteria: Previous cardiac mitral valve surgery; Patients with Infective endocarditis or having an active infection; Patients with mitral regurgitation caused by pure mitral stenosis; Combined with untreated severe coronary artery disease Pulmonary hypertension (pulmonary artery systolic pressure>70mmHg); Patients with severe right heart failure; Patients are extremely weak and cannot tolerate general anesthesia or are in shock that circulatory support is needed; Patients with hypertrophic cardiomyopathy, restrictive cardiomyopathy, and constrictive pericarditis; Patients receiving chronic dialysis; Patients with clear coagulation dysfunction and severe coagulopathy; Patients with clear contraindications to anticoagulant drugs; Patients with stroke or transient ischemic attack within 30 days; Echocardiography found any intracardiac mass, left ventricle or atrial thrombus; Patients who require surgery or interventional therapy for other valvular lesions; Patients with severe macrovascular lesions requiring surgical treatment; Patients' imaging examinations suggest that the anatomy of the heart and valves are inappropriate;

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Transcatheter Mitral Valve Repair with Valveclip® | Device: Valveclip® Transcatheter mitral valve repair<br>* Transcatheter mitral valve repair system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of product | Efficacy of product is defined as the proportion of participants meeting effective standards after surgery (freedom from death, mitral valve reoperation or MR>2+ at 12 months). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of product | Efficacy of product is defined as the proportion of participants meeting effective standards after surgery (freedom from death, mitral valve reoperation or MR>2+ at 30 days, 180 days, 2 to 5 years). | 30 days, 180 days, 2 to 5 years | 
| Rate of Cardiovascular related mortality | Cardiovascular related mortality after Transcatheter Mitral Valve Repairment | 30 days, 180 days, 1 year, 2 to 5 years | 
| Rate of Severe adverse events | Severe adverse events after Transcatheter Mitral Valve Repairment (including death, stroke, myocardial infarction, reoperation, instrumental non-selective cardiovascular surgery, renal failure, and adverse events related to transfemoral vein septal approach surgery, etc.） | 30 days, 180 days, 1 year, 2 to 5 years | 
| Quality of life Improvement | The 12-Item Short-Form Health Survey(SF-12) | 30 days, 180 days, 1 year, 2 to 5 years |