Transcatheter mitral valve repair for severe mitral regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of the Valveclip® transcatheter mitral valve repair system in patients suffering from moderate to severe degenerative mitral regurgitation. It is a prospective, multi-center, single-arm study designed to assess the performance of this innovative treatment approach. Participants will be selected based on specific criteria, including age and risk factors for traditional surgery, and will undergo thorough evaluations by a multidisciplinary cardiac team.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Severe mitral regurgitation≥3+ (moderate or above degenerative mitral regurgitation disease, or with stenosis is included);
2. 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：

1. The regurgitant jet of mitral valve originates from the A2 and P2 (the lesions of A2/P2 in mitral valve causes regurgitation);
2. 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);
3. Effective mitral valve orifice area≥ 4.0cm2;
4. No obvious calcification of the mitral valve annulus and valve leaflets;
5. Patient's anatomical conditions allow transseptal approach.

Exclusion Criteria:

1. Previous cardiac mitral valve surgery;
2. Patients with Infective endocarditis or having an active infection;
3. Patients with mitral regurgitation caused by pure mitral stenosis;
4. Combined with untreated severe coronary artery disease
5. Pulmonary hypertension (pulmonary artery systolic pressure\>70mmHg);
6. Patients with severe right heart failure;
7. Patients are extremely weak and cannot tolerate general anesthesia or are in shock that circulatory support is needed;
8. Patients with hypertrophic cardiomyopathy, restrictive cardiomyopathy, and constrictive pericarditis;
9. Patients receiving chronic dialysis;
10. Patients with clear coagulation dysfunction and severe coagulopathy;
11. Patients with clear contraindications to anticoagulant drugs;
12. Patients with stroke or transient ischemic attack within 30 days;
13. Echocardiography found any intracardiac mass, left ventricle or atrial thrombus;
14. Patients who require surgery or interventional therapy for other valvular lesions;
15. Patients with severe macrovascular lesions requiring surgical treatment;
16. Patients' imaging examinations suggest that the anatomy of the heart and valves are inappropriate;

Where it's running

• Department of Cardiology, West China Hospital, Sichuan University
  Sichuan, China Recruiting

Study contacts

• Principal investigator: mao Chen, Chief — West China Hospital
• Study coordinator: chunyang Wang, CRA
• Email: cywang@newmed.cn
• Phone: (86)-21-20788668

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• GeminiOne transcatheter edge-to-edge repair for severe symptomatic mitral regurgitation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.