NCT05021614 Valveclip® Transcatheter Mitral Valve Repair Study
| NCT ID | NCT05021614 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai NewMed Medical Co., Ltd. |
| Condition | Mitral Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-09-24 |
| Primary Completion | 2024-06 |
Trial Parameters
Eligibility Fast-Check
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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.
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 Pr