Valveclip® Transcatheter Mitral Valve Repair Study

NCT05021614 | Recruiting DMC

• 1 other identifier: M-clip-2020-09
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Efficacy of product

  Efficacy of product is defined as the proportion of participants meeting effective standards after surgery (freedom from death, mitral valve reoperation or MR\>2+ at 12 months).

  12 months

Secondary Outcomes (4)

• Efficacy of product

  30 days, 180 days, 2 to 5 years

• Rate of Cardiovascular related mortality

  30 days, 180 days, 1 year, 2 to 5 years

• Rate of Severe adverse events

  30 days, 180 days, 1 year, 2 to 5 years

• Quality of life Improvement

  30 days, 180 days, 1 year, 2 to 5 years

Other Outcomes (3)

• Technical success

  immediate post-surgical

• Device success

  30 days、180 days、1 year

• Procedural success

  30 days

Study Arms (1)

Treatment

EXPERIMENTAL

Transcatheter Mitral Valve Repair with Valveclip®

Device: Valveclip® Transcatheter mitral valve repair

Interventions

Valveclip® Transcatheter mitral valve repair DEVICE

Transcatheter mitral valve repair system

Treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe mitral regurgitation≥3+ (moderate or above degenerative mitral regurgitation disease, or with stenosis is included);
• 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;
• \) 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：
• The regurgitant jet of mitral valve originates from the A2 and P2 (the lesions of A2/P2 in mitral valve causes regurgitation);
• 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);
• Effective mitral valve orifice area≥ 4.0cm2;
• No obvious calcification of the mitral valve annulus and valve leaflets;
• Patient's anatomical conditions allow transseptal approach.

You may not qualify if:

• Previous cardiac mitral valve surgery;
• Patients with Infective endocarditis or having an active infection;
• Patients with mitral regurgitation caused by pure mitral stenosis;
• Combined with untreated severe coronary artery disease
• Pulmonary hypertension (pulmonary artery systolic pressure\>70mmHg);
• Patients with severe right heart failure;
• Patients are extremely weak and cannot tolerate general anesthesia or are in shock that circulatory support is needed;
• Patients with hypertrophic cardiomyopathy, restrictive cardiomyopathy, and constrictive pericarditis;
• Patients receiving chronic dialysis;
• Patients with clear coagulation dysfunction and severe coagulopathy;
• Patients with clear contraindications to anticoagulant drugs;
• Patients with stroke or transient ischemic attack within 30 days;
• Echocardiography found any intracardiac mass, left ventricle or atrial thrombus;
• Patients who require surgery or interventional therapy for other valvular lesions;
• Patients with severe macrovascular lesions requiring surgical treatment;

Sponsors & Collaborators

• Shanghai NewMed Medical Co., Ltd.: lead

Study Sites (1)

Department of Cardiology, West China Hospital, Sichuan University

Sichuan, China

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• mao Chen, Chief

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

chunyang Wang, CRA

CONTACT

(86)-21-20788668; cywang@newmed.cn

xuyang Xie

CONTACT

(86)-21-20788668; xyxie@newmed.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 25, 2021
• Study Start: September 24, 2021
• Primary Completion: June 1, 2024
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)