Multi-center Trial of ValveClamp (CLAMP)

Fudan University

Status: Enrolling

Conditions: Evaluate the Safety and Efficacy of the ValveClamp

Treatments: Device: ValveClamp

Study type: Interventional

Funder types: Other

Identifiers

NCT03869164

YL-2018-27

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

110 participants in 1 patient group

ValmpClamp Arm

Experimental group

Treatment:

Device: ValveClamp