🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05021614
Recruiting Not applicable

Valveclip® Transcatheter Mitral Valve Repair Study

NCT05021614 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai NewMed Medical Co., Ltd.
Phase
Not applicable
Started
2021-09-24
Last updated
2023-11-18

Condition(s) studied

Mitral Regurgitation

Investigational drug(s) / intervention(s)

Valveclip® Transcatheter mitral valve repair

Valveclip® Transcatheter mitral valve repair: Transcatheter mitral valve repair system

Study 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

Sex
ALL
Min age
60 Years
Max age
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

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

More Shanghai NewMed Medical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05021614 on ClinicalTrials.gov ↗ ← All trials in China