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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
ValveClamp is an easy-to-operate transcatheter edge-to-edge mitral valve repair system with larger coaptation width
Zhongshan Hopital of Fudan University
Shanghai, Shanghai, China, China
RECRUITINGThe device success rate
freedom from the composite end point of death from any cause, surgery for valve dysfunction, and MR ≥3+ at one month.
Time frame: 12months
Incidence of adverse cardiovascular events
death, severe arrhythmia, pericardial tamponade, emergency surgery, cardiac shock, endocarditis, bleeding , and other complications caused by procedure
Time frame: immediate post-operation
Incidence of deaths
All cause deaths (cardiac death, and non cardiac death) or strokes
Time frame: 1,6,12months
Incidence of mitral valve re-surgery
Mitral valve re-surgery because of the failure of operation, embolism, clamp's falling off.
Time frame: 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.
Time frame: 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.
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Time frame: 1,6,12months
brain natriuretic peptide
BNP is a kind of laboratory blood test index to reflect the cardiac function.
Time frame: 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.
Time frame: 1,6,12months