Valveclip® Transcatheter Mitral Valve Repair Study

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

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;

• 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;