Evaluation of the ValveClamp for mitral valve repair

Multi-center Trial of Transcatheter Edge-to-edge Mitral Valve Repair With ValveClamp System in High Risk Patients With Degerative Mitral Regurgitation

This study is testing a new device called the ValveClamp to see if it can safely help older patients with severe mitral valve problems feel better without needing traditional surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai, China)
• Trial ID: NCT03869164 on ClinicalTrials.gov

What this trial studies

The ValveClamp is a newly developed transcatheter edge-to-edge mitral valve repair system designed for patients with degenerative mitral regurgitation. This multi-center trial aims to assess the safety and efficacy of the ValveClamp, which features a simpler operation compared to existing devices like MitraClip and PASCAL. The study will involve patients over 60 years old who exhibit moderate to severe symptoms related to mitral regurgitation and are considered high risk for traditional surgery. Participants will be monitored for outcomes related to the device's performance and patient health improvements.

Who should consider this trial

Good fit: Ideal candidates are patients over 60 years old with moderate to severe mitral regurgitation and related symptoms who are at high risk for surgery.

Not a fit: Patients with acute myocardial infarction, recent cardiac procedures, or other significant cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could provide a less invasive treatment option for patients with significant mitral regurgitation, improving their quality of life.

How similar studies have performed: While the ValveClamp represents a novel approach, similar devices like MitraClip and PASCAL have shown success in treating mitral regurgitation.

Eligibility criteria

Inclusion Criteria:

1. age older than 60 years;
2. moderate to severe or severe mitral regurgitation;
3. symptoms (New York Heart Association \[NYHA\] cardiac function class ≥2) related to MR;
4. the primary regurgitant jet originated from malcoaptation of the A2 and P2 scallops of the mitral valve;
5. high risk for surgery according the MVARC criteria;
6. providing signed informed consent.

Exclusion Criteria:

1. acute myocardial infarction in the prior 4 weeks of the intended treatment;
2. any interventional or surgical cardiac procedure performed within 30 days prior;
3. the need for any other cardiac surgery;
4. echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
5. life expectancy within 12 months;
6. moderate or severe aortic stenosis or regurgitation;
7. mitral valve orifice area \<3.5 cm2;
8. untreated significant coronary stenosis;
9. history of mitral valvuloplasty;
10. Infective endocarditis and rheumatic heart disease;
11. untreated cardiogenic shock, acute pulmonary congestion;
12. unfavored mitral valve anatomy that may preclude device implantation including: calcification or significant cleft in area of the A2 and/or P2 scallops, significant regurgitation beyond A2 or P2 scallops and short posterior leaflet (\<10mm).
13. Other clinical trials that the subjects participated in have not reached the end point.

Where this trial is running

Shanghai, Shanghai, China

• Zhongshan Hopital of Fudan University — Shanghai, Shanghai, China, China (Recruiting)

Study contacts

• Principal investigator: Wenzhi Pan, M.D. — Department of Cardiology, Zhongshan Hospital, Fudan University
• Study coordinator: Wenzhi Pan, M.D.

Conditions Evaluate the Safety and Efficacy of the ValveClamp