Multi-center Trial of ValveClamp

NCT ID: NCT03869164

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-12
• Study Completion Date: 2025-12-08

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.

Conditions

Evaluate the Safety and Efficacy of the ValveClamp

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ValmpClamp Arm

Group Type: EXPERIMENTAL

ValveClamp

Intervention Type: DEVICE

ValveClamp is an easy-to-operate transcatheter edge-to-edge mitral valve repair system with larger coaptation width

Interventions

ValveClamp

ValveClamp is an easy-to-operate transcatheter edge-to-edge mitral valve repair system with larger coaptation width

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenzhi Pan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Zhongshan Hospital, Fudan University

Locations

Zhongshan Hopital of Fudan University

Shanghai, Shanghai, China, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenzhi Pan, M.D.

Role: CONTACT

peden@sina.com

13774475922

Facility Contacts

Wenzhi Pan, M.D.

Role: primary

Other Identifiers

YL-2018-27

Identifier Type: -

Identifier Source: org_study_id