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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ValmpClamp Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ValveClamp | Device | ValveClamp is an easy-to-operate transcatheter edge-to-edge mitral valve repair system with larger coaptation width |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenzhi Pan, M.D. | Contact | 13774475922 | peden@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenzhi Pan, M.D. | Department of Cardiology, Zhongshan Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hopital of Fudan University | Recruiting | Shanghai | Shanghai, China | 200032 | China |
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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 |