Multi-center Trial of Transcatheter Edge-to-edge Mitral Valve Repair With ValveClamp System in High Risk Patients With Degerative Mitral Regurgitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- The device success rate
Study Overview
Brief Summary
The ValveClamp (Hanyu Medical Technology, Shanghai, China) is the first edge-to-edge mitral valve repair system for interventional operation in China, which is composed of the front clamp, the rear clamp and the closed ring. The purpose of the multi-center trial is to evaluate the safety and efficacy of the ValveClamp for degenerative mirtal regurgistation.
Detailed Description
The transcatheter edge-to-edge mitral valve repair device MitraClip (Abbott Vascular, Santa Clara, CA, USA) is the most mature device for mitral regurgitation. Another transcatheter edge-to-edge mitral valve repair device, the PASCAL system, has been shown to be feasible to reduce MR severity. Both the MitraClip and PASCAL devices need a complex steerable deliver system and thus complex process to steer the device to mitral valve. An easy-to-operate transcatheter edge-to-edge mitral valve repair system (ValveClamp) with larger coaptation width was thus recently developed in China. The ValveClamp (Hanyu Medical Technology, Shanghai, China) is the first edge-to-edge mitral valve repair system for interventional operation in China, which is composed of the front clamp, the rear clamp and the closed ring. The purpose of the multi-center trial is to evaluate the safety and efficacy of the ValveClamp for degenerative mirtal regurgistation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age older than 60 years;
- •moderate to severe or severe mitral regurgitation;
- •symptoms (New York Heart Association [NYHA] cardiac function class ≥2) related to MR;
- •the primary regurgitant jet originated from malcoaptation of the A2 and P2 scallops of the mitral valve;
- •high risk for surgery according the MVARC criteria;
- •providing signed informed consent.
Exclusion Criteria
- •acute myocardial infarction in the prior 4 weeks of the intended treatment;
- •any interventional or surgical cardiac procedure performed within 30 days prior;
- •the need for any other cardiac surgery;
- •echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
- •life expectancy within 12 months;
- •moderate or severe aortic stenosis or regurgitation;
- •mitral valve orifice area <3.5 cm2;
- •untreated significant coronary stenosis;
- •history of mitral valvuloplasty;
- •Infective endocarditis and rheumatic heart disease;
- •untreated cardiogenic shock, acute pulmonary congestion;
- •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).
- •Other clinical trials that the subjects participated in have not reached the end point.
Outcomes
Primary Outcomes
The device success rate
Time Frame: 12months
freedom from the composite end point of death from any cause, surgery for valve dysfunction, and MR ≥3+ at one month.
Secondary Outcomes
- Incidence of adverse cardiovascular events(immediate post-operation)
- Incidence of deaths(1,6,12months)
- Incidence of mitral valve re-surgery(1,6,12months)
- Grading of mitral regurgitation by echocardiography(1,6,12months)
- New York Heart Association (NYHA) class(1,6,12months)
- brain natriuretic peptide(1,6,12months)
- severe adverse events(1,6,12months)