Multi-center Trial of ValveClamp (CLAMP)

• ClinicalTrials.gov Identifier: NCT03869164
• Recruitment Status: Recruiting
• First Posted: March 11, 2019
• Last Update Posted: May 27, 2020
• Sponsor: Shanghai Zhongshan Hospital
• Information provided by (Responsible Party): Shanghai Zhongshan Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Evaluate the Safety and Efficacy of the ValveClamp	Device: ValveClamp	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 110 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multi-center Trial of Transcatheter Edge-to-edge Mitral Valve Repair With ValveClamp System in High Risk Patients With Degerative Mitral Regurgitation
• Actual Study Start Date: February 12, 2019
• Estimated Primary Completion Date: December 13, 2021
• Estimated Study Completion Date: December 8, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: ValmpClamp Arm	Device: ValveClamp; ValveClamp is an easy-to-operate transcatheter edge-to-edge mitral valve repair system with larger coaptation width

Outcome Measures

Primary Outcome Measures :

1. The device success rate [ Time Frame: 12months ]
   freedom from the composite end point of death from any cause, surgery for valve dysfunction, and MR ≥3+ at one month.

Secondary Outcome Measures :

1. Incidence of adverse cardiovascular events [ Time Frame: immediate post-operation ]
   death, severe arrhythmia, pericardial tamponade, emergency surgery, cardiac shock, endocarditis, bleeding , and other complications caused by procedure
2. Incidence of deaths [ Time Frame: 1,6,12months ]
   All cause deaths (cardiac death, and non cardiac death) or strokes
3. Incidence of mitral valve re-surgery [ Time Frame: 1,6,12months ]
   Mitral valve re-surgery because of the failure of operation, embolism, clamp's falling off.
4. Grading of mitral regurgitation by echocardiography [ Time Frame: 1,6,12months ]
   The echocardiographic analysis was performed according to the American Society of Echocardiography guidelines. The severity of MR was graded as none or trac e (0+), mild(1+), moderate(2+), moderate to severe (3+) or severe (4+) by using the EVERST criteria.
5. New York Heart Association (NYHA) class [ Time Frame: 1,6,12months ]
   The NYHA cardiac function class containing the levels of Ⅰ, Ⅱ, Ⅲ, Ⅳ, relies on the concept of ordinary physical activities. Class Ⅰ means that patients have cardiac disease but without the resulting limitations of physical activity. Class Ⅱ means that patients have cardiac disease resulting in slight limitation of physical activity. Class Ⅲ refers to that patients have cardiac disease resulting in marked limitation of physical activity. Class Ⅳ refers to that patients have cardiac disease resulting in inability to carry on any physical activity without discomfort.
6. brain natriuretic peptide [ Time Frame: 1,6,12months ]
   BNP is a kind of laboratory blood test index to reflect the cardiac function.
7. severe adverse events [ Time Frame: 1,6,12months ]
   Severe adverse events include injury of mitral valves, re-inpatient for poor cardiac function and other severe adverse events.

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Wenzhi Pan, M.D.; 13774475922; peden@sina.com

Locations

China, Shanghai, China

Zhongshan Hopital of Fudan University; Recruiting

Shanghai, Shanghai, China, China, 200032

Contact: Wenzhi Pan, M.D.

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

• Principal Investigator: Wenzhi Pan, M.D.; Department of Cardiology, Zhongshan Hospital, Fudan University

More Information

• Responsible Party: Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT03869164
• Other Study ID Numbers: YL-2018-27
• First Posted: March 11, 2019
• Last Update Posted: May 27, 2020
• Last Verified: May 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No