Multi-center Trial of ValveClamp (CLAMP)

Multi-center Trial of Transcatheter Edge-to-edge Mitral Valve Repair With ValveClamp System in High Risk Patients With Degerative Mitral Regurgitation

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 Overview

• Status: Recruiting
• Conditions: Evaluate the Safety and Efficacy of the ValveClamp
• Intervention / Treatment: Device: ValveClamp

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 Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenzhi Pan, M.D.; Phone Number: 13774475922; Email: peden@sina.com

Study Locations

• China
  • Shanghai, China
    • Shanghai, Shanghai, China, China, 200032
      • Recruiting
      • Zhongshan Hopital of Fudan University
      • Contact: Wenzhi Pan, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse cardiovascular events	death, severe arrhythmia, pericardial tamponade, emergency surgery, cardiac shock, endocarditis, bleeding , and other complications caused by procedure	immediate post-operation
Incidence of deaths	All cause deaths (cardiac death, and non cardiac death) or strokes	1,6,12months
Incidence of mitral valve re-surgery	Mitral valve re-surgery because of the failure of operation, embolism, clamp's falling off.	1,6,12months
Grading of mitral regurgitation by echocardiography	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.	1,6,12months
New York Heart Association (NYHA) class	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.	1,6,12months
brain natriuretic peptide	BNP is a kind of laboratory blood test index to reflect the cardiac function.	1,6,12months
severe adverse events	Severe adverse events include injury of mitral valves, re-inpatient for poor cardiac function and other severe adverse events.	1,6,12months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2019
• Primary Completion (ANTICIPATED): December 13, 2021
• Study Completion (ANTICIPATED): December 8, 2025

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (ACTUAL): March 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 25, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: YL-2018-27

Drug and device information, study documents

• 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