Actively Recruiting
Valveclip® Transcatheter Mitral Valve Repair Study
Led by Shanghai NewMed Medical Co., Ltd. · Updated on 2023-11-18
150
Participants Needed
1
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Valveclip® Transcatheter Mitral Valve Repair Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate or above degenerative mitral regurgitation (grade 653+)
- Age 70 years or older, or age 60 to 70 years with high surgical risk or unable to tolerate traditional surgery
- Left ventricular ejection fraction 30% or higher
- Assessed by a multidisciplinary cardiac team as extremely high risk or unsuitable for routine mitral valve surgery
- Able to understand the trial, consent to participate, and willing to undergo examinations and follow-up
- Mitral valve regurgitation from the A2 and P2 segments
- Mitral valve prolapse width 15mm, prolapse height 10mm, coaptation depth 11mm, coaptation height 2mm, and effective leaflet length over 1cm
- Effective mitral valve orifice area 4.0 cm2 or greater
- No significant calcification of the mitral valve annulus or leaflets
- Anatomical suitability for transseptal approach
You will not qualify if you...
- Previous cardiac mitral valve surgery
- Infective endocarditis or active infection
- Mitral regurgitation caused by pure mitral stenosis
- Untreated severe coronary artery disease
- Pulmonary hypertension with pulmonary artery systolic pressure over 70 mmHg
- Severe right heart failure
- Unable to tolerate general anesthesia or in shock requiring circulatory support
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis
- Receiving chronic dialysis
- Clear coagulation dysfunction or severe coagulopathy
- Contraindications to anticoagulant drugs
- Stroke or transient ischemic attack within 30 days
- Intracardiac mass or left ventricle/atrial thrombus seen on echocardiography
- Need for surgery or intervention for other valvular lesions
- Severe macrovascular lesions requiring surgery
- Heart and valve anatomy unsuitable based on imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Cardiology, West China Hospital, Sichuan University
Sichuan, China
Actively Recruiting
Research Team
C
chunyang Wang, CRA
CONTACT
X
xuyang Xie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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