Multi-center Trial of ValveClamp

Not Applicable

Recruiting

• Conditions: Evaluate the Safety and Efficacy of the ValveClamp

• Registration Number: NCT03869164
• Lead Sponsor: Shanghai Zhongshan Hospital

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 Timeline

• Study Start: 2019-02-12
• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-11
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-25
• Last Update Posted: 2020-05-27
• Primary Completion: 2021-12-13
• Study Completion: 2025-12-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Incidence of deaths	1,6,12months	All cause deaths (cardiac death, and non cardiac death) or strokes
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.
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.
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.
Incidence of mitral valve re-surgery	1,6,12months	Mitral valve re-surgery because of the failure of operation, embolism, clamp's falling off.

Trial Locations

Locations (1)

Zhongshan Hopital of Fudan University; 🇨🇳 Shanghai, Shanghai, China, China