Clinical trial NCT05021614: Valveclip® Transcatheter Mitral Valve Repair Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: Shanghai NewMed Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-25
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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;

Primary outcomes:
measure: Efficacy of product
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy of product
timeFrame: 30 days, 180 days, 2 to 5 years
measure: Rate of Cardiovascular related mortality
timeFrame: 30 days, 180 days, 1 year, 2 to 5 years
measure: Rate of Severe adverse events
timeFrame: 30 days, 180 days, 1 year, 2 to 5 years
measure: Quality of life Improvement
timeFrame: 30 days, 180 days, 1 year, 2 to 5 years
Other outcomes:
measure: Technical success
timeFrame: immediate post-surgical
measure: Device success
timeFrame: 30 days、180 days、1 year
measure: Procedural success
timeFrame: 30 days
Locations:
city: Sichuan
country: China
facility: Department of Cardiology, West China Hospital, Sichuan University
Study officials:
affiliation: West China Hospital
name: mao Chen, Chief
role: PRINCIPAL_INVESTIGATOR
References: