Multi-center Trial of ValveClamp

Overview

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.

Full Title of Study: “Multi-center Trial of Transcatheter Edge-to-edge Mitral Valve Repair With ValveClamp System in High Risk Patients With Degerative Mitral Regurgitation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 13, 2021

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.

Interventions

  • Device: ValveClamp
    • ValveClamp is an easy-to-operate transcatheter edge-to-edge mitral valve repair system with larger coaptation width

Arms, Groups and Cohorts

  • Experimental: ValmpClamp Arm

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • Incidence of deaths
    • Time Frame: 1,6,12months
    • All cause deaths (cardiac death, and non cardiac death) or strokes
  • 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.
  • 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.
  • 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.
  • brain natriuretic peptide
    • Time Frame: 1,6,12months
    • BNP is a kind of laboratory blood test index to reflect the cardiac function.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Zhongshan Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wenzhi Pan, M.D., Principal Investigator, Department of Cardiology, Zhongshan Hospital, Fudan University
  • Overall Contact(s)
    • Wenzhi Pan, M.D., 13774475922, peden@sina.com

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