NCT03869164

Multi-center Trial of ValveClamp

Multi-center Trial of Transcatheter Edge-to-edge Mitral Valve Repair With ValveClamp System in High Risk Patients With Degerative Mitral Regurgitation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2019-02-12
• Primary completion: 2021-12-13
• Completion: 2025-12-08
• First posted: 2019-03-11
• Last updated: 2020-05-27

Locations

1 site across 1 country: China