Transcatheter mitral valve repair for severe mitral regurgitation

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

This study is testing a new device called Valveclip® to see if it can safely help people with moderate to severe mitral regurgitation feel better without needing traditional surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Shanghai NewMed Medical Co., Ltd. (industry)
• Locations: 1 site (Sichuan)
• Trial ID: NCT05021614 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 60 years and older with severe mitral regurgitation who are considered high-risk for conventional surgical interventions.

Not a fit: Patients with mild mitral regurgitation or those who are not at high risk for traditional surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a less invasive option for patients with severe mitral regurgitation who are at high risk for traditional surgery.

How similar studies have performed: Other studies have shown promise with transcatheter approaches for mitral valve repair, indicating a growing body of evidence supporting this innovative treatment.

Eligibility criteria

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 this trial is running

Sichuan

• 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

Conditions: Mitral Regurgitation