Evaluate the Safety and Efficacy of the ValveClamp
Conditions
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.
Interventions
DEVICEValveClamp
ValveClamp is an easy-to-operate transcatheter edge-to-edge mitral valve repair system with larger coaptation width
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The device success rate | 12months | freedom from the composite end point of death from any cause, surgery for valve dysfunction, and MR ≥3+ at one month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of deaths | 1,6,12months | All cause deaths (cardiac death, and non cardiac death) or strokes |
| Incidence of mitral valve re-surgery | 1,6,12months | Mitral valve re-surgery because of the failure of operation, embolism, clamp's falling off. |
| Grading of mitral regurgitation by echocardiography | 1,6,12months | 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. |
| Incidence of adverse cardiovascular events | immediate post-operation | death, severe arrhythmia, pericardial tamponade, emergency surgery, cardiac shock, endocarditis, bleeding , and other complications caused by procedure |
| brain natriuretic peptide | 1,6,12months | BNP is a kind of laboratory blood test index to reflect the cardiac function. |
| severe adverse events | 1,6,12months | Severe adverse events include injury of mitral valves, re-inpatient for poor cardiac function and other severe adverse events. |
| New York Heart Association (NYHA) class | 1,6,12months | 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. |
Countries
China
Contacts
Primary ContactWenzhi Pan, M.D.
Outcome results
None listed