Multi-center Trial of Transcatheter Edge-to-edge Mitral Valve Repair With ValveClamp System in High Risk Patients With Degerative Mitral Regurgitation
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• age older than 60 years;
• moderate to severe or severe mitral regurgitation;
• symptoms (New York Heart Association \[NYHA\] cardiac function class ≥2) related to MR;
• the primary regurgitant jet originated from malcoaptation of the A2 and P2 scallops of the mitral valve;
• high risk for surgery according the MVARC criteria;
• providing signed informed consent.
Locations
Other Locations
China
Zhongshan Hopital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Wenzhi Pan, M.D.
peden@sina.com
13774475922
Time Frame
Start Date: 2019-02-12
Estimated Completion Date: 2025-12-08
Participants
Target number of participants: 110
Treatments
Experimental: ValmpClamp Arm
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital