Valveclip® Transcatheter Mitral Valve Repair Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: Valveclip® Transcatheter mitral valve repair

Detailed Description

This study is a prospective,multi-center, single-arm, safety and performance clinical study.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: chunyang Wang, CRA; Phone Number: (86)-21-20788668; Email: cywang@newmed.cn
• Study Contact Backup: Name: xuyang Xie; Phone Number: (86)-21-20788668; Email: xyxie@newmed.cn

Study Locations

• China
  • Sichuan, China
    • Recruiting
    • Department of Cardiology, West China Hospital, Sichuan University
    • Contact: mao Chen, Chief

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Transcatheter Mitral Valve Repair with Valveclip®	Device: Valveclip® Transcatheter mitral valve repair; Transcatheter mitral valve repair system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 30 days, 180 days, 2 to 5 years).	30 days, 180 days, 2 to 5 years
Rate of Cardiovascular related mortality	Cardiovascular related mortality after Transcatheter Mitral Valve Repairment	30 days, 180 days, 1 year, 2 to 5 years
Rate of Severe adverse events	Severe adverse events after Transcatheter Mitral Valve Repairment (including death, stroke, myocardial infarction, reoperation, instrumental non-selective cardiovascular surgery, renal failure, and adverse events related to transfemoral vein septal approach surgery, etc.）	30 days, 180 days, 1 year, 2 to 5 years
Quality of life Improvement	The 12-Item Short-Form Health Survey(SF-12)	30 days, 180 days, 1 year, 2 to 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Technical success after Transcatheter Mitral Valve Repairment	immediate post-surgical
Device success	Device success after Transcatheter Mitral Valve Repairment	30 days、180 days、1 year
Procedural success	Procedural success after Transcatheter Mitral Valve Repairment	30 days

Collaborators and Investigators

• Sponsor: Shanghai NewMed Medical Co., Ltd.
• Investigators: Principal Investigator: mao Chen, Chief, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: M-clip-2020-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No