Multi-center Trial of ValveClamp

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Evaluate the Safety and Efficacy of the ValveClamp

Intervention / Treatment
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* Device: ValveClamp


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ValmpClamp Arm<br> | Device: ValveClamp<br>* ValveClamp is an easy-to-operate transcatheter edge-to-edge mitral valve repair system with larger coaptation width<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The device success rate | freedom from the composite end point of death from any cause, surgery for valve dysfunction, and MR ≥3+ at one month. | 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse cardiovascular events | death, severe arrhythmia, pericardial tamponade, emergency surgery, cardiac shock, endocarditis, bleeding , and other complications caused by procedure | immediate post-operation | 
| Incidence of deaths | All cause deaths (cardiac death, and non cardiac death) or strokes | 1,6,12months | 
| Incidence of mitral valve re-surgery | Mitral valve re-surgery because of the failure of operation, embolism, clamp's falling off. | 1,6,12months | 
| Grading of mitral regurgitation by echocardiography | The echocardiographic analysis was performed according to the American Society of Echocardiography guidelines. The severity of MR was graded as none or trac e (0+), mild(1+), moderate(2+), moderate to severe (3+) or severe (4+) by using the EVERST criteria. | 1,6,12months | 
| New York Heart Association (NYHA) class | The NYHA cardiac function class containing the levels of Ⅰ, Ⅱ, Ⅲ, Ⅳ, relies on the concept of ordinary physical activities. Class Ⅰ means that patients have cardiac disease but without the resulting limitations of physical activity. Class Ⅱ means that patients have cardiac disease resulting in slight limitation of physical activity. Class Ⅲ refers to that patients have cardiac disease resulting in marked limitation of physical activity. Class Ⅳ refers to that patients have cardiac disease resulting in inability to carry on any physical activity without discomfort. | 1,6,12months | 
| brain natriuretic peptide | BNP is a kind of laboratory blood test index to reflect the cardiac function. | 1,6,12months | 
| severe adverse events | Severe adverse events include injury of mitral valves, re-inpatient for poor cardiac function and other severe adverse events. | 1,6,12months |