Status:
UNKNOWN
Multi-center Trial of ValveClamp
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Evaluate the Safety and Efficacy of the ValveClamp
Eligibility:
All Genders
60+ years
Phase:
NA
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 cl...
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 mitra...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- acute myocardial infarction in the prior 4 weeks of the intended treatment;
- any interventional or surgical cardiac procedure performed within 30 days prior;
- the need for any other cardiac surgery;
- echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
- life expectancy within 12 months;
- moderate or severe aortic stenosis or regurgitation;
- mitral valve orifice area \<3.5 cm2;
- untreated significant coronary stenosis;
- history of mitral valvuloplasty;
- Infective endocarditis and rheumatic heart disease;
- untreated cardiogenic shock, acute pulmonary congestion;
- 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).
- Other clinical trials that the subjects participated in have not reached the end point.
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 8 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03869164
Start Date
February 12 2019
End Date
December 8 2025
Last Update
May 27 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zhongshan Hopital of Fudan University
Shanghai, Shanghai, China, China, 200032