Valveclip® Transcatheter Mitral Valve Repair Study

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05021614
• Other study ID #: M-clip-2020-09
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2021
• Est. completion date: September 2027

Study information

• Verified date: November 2023
• Source: Shanghai NewMed Medical Co., Ltd.
• Contact: chunyang Wang, CRA
• Phone: (86)-21-20788668
• Email: cywang[@]newmed.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2027
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

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

Locations

Country	Name	City	State
China	Department of Cardiology, West China Hospital, Sichuan University	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai NewMed Medical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Technical success	Technical success after Transcatheter Mitral Valve Repairment	immediate post-surgical
Other	Device success	Device success after Transcatheter Mitral Valve Repairment	30 days?180 days?1 year
Other	Procedural success	Procedural success after Transcatheter Mitral Valve Repairment	30 days
Primary	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	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
Secondary	Rate of Cardiovascular related mortality	Cardiovascular related mortality after Transcatheter Mitral Valve Repairment	30 days, 180 days, 1 year, 2 to 5 years
Secondary	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
Secondary	Quality of life Improvement	The 12-Item Short-Form Health Survey(SF-12)	30 days, 180 days, 1 year, 2 to 5 years