Clinical trial NCT03869164: Multi-center Trial of ValveClamp
Official title: Multi-center Trial of Transcatheter Edge-to-edge Mitral Valve Repair With ValveClamp System in High Risk Patients With Degerative Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Evaluate the Safety and Efficacy of the ValveClamp
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 110
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The device success rate
timeFrame: 12months
Secondary outcomes:
measure: Incidence of adverse cardiovascular events
timeFrame: immediate post-operation
measure: Incidence of deaths
timeFrame: 1,6,12months
measure: Incidence of mitral valve re-surgery
timeFrame: 1,6,12months
measure: Grading of mitral regurgitation by echocardiography
timeFrame: 1,6,12months
measure: New York Heart Association (NYHA) class
timeFrame: 1,6,12months
measure: brain natriuretic peptide
timeFrame: 1,6,12months
measure: severe adverse events
timeFrame: 1,6,12months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hopital of Fudan University
state: Shanghai, China
Study officials:
affiliation: Department of Cardiology, Zhongshan Hospital, Fudan University
name: Wenzhi Pan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: