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

Shanghai NewMed Medical Co., Ltd.1 site in 1 country150 target enrollmentSeptember 24, 2021

ConditionsMitral Regurgitation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mitral Regurgitation
Sponsor: Shanghai NewMed Medical Co., Ltd.
Enrollment: 150
Locations: 1
Primary Endpoint: Efficacy of product
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 24, 2021

End Date

September 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai NewMed Medical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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;

Outcomes

Primary Outcomes

Efficacy of product

Time Frame: 12 months

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).

Secondary Outcomes

Rate of Severe adverse events(30 days, 180 days, 1 year, 2 to 5 years)
Efficacy of product(30 days, 180 days, 2 to 5 years)
Quality of life Improvement(30 days, 180 days, 1 year, 2 to 5 years)
Rate of Cardiovascular related mortality(30 days, 180 days, 1 year, 2 to 5 years)