DragonFly M2 Pivotal Study

NCT ID: NCT07243197

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2031-06-30

Brief Summary

To confirm the effectiveness and safety of the DragonFly M2 Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects.The safety and effectiveness of the first-generation device(Dragonfly Transcatheter Mitral Valve Repair System)have been previously demonstrated. This study aims to further confirm the safety and effectiveness of the new device following structural optimization based on the first-generation design.

Detailed Description

This is a prospective, multicentric clinical investigation.

Subjects to be included in this clinical investigation suffer from symptomatic chronic moderate-to-severe (3+) or severe (4+) DMR with high or prohibitive surgical risk judged by a local investigation site's heart team .

After signing an informed consent form, subjects in the experimental group will undergo the transcatheter mitral valve repair procedure using the DragonFly M2 Transcatheter Mitral Valve Clip System. All subjects were followed up immediately after procedure, before discharge, 30 days , 6 months, 12 months after procedure, and 2, 3, 4, and 5 years after procedure.

Conditions

Mitral Valve (MV) Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DragonFly M2 Transcatheter Mitral Valve Repair System

Transcatheter mitral valve repair with the DragonFly M2 System in patients with degenerative mitral regurgitation

Group Type: EXPERIMENTAL

DragonFly M2 Transcatheter Mitral Valve Repair System

Intervention Type: DEVICE

Edge-to-edge repair with DragonFly M2 System

Interventions

DragonFly M2 Transcatheter Mitral Valve Repair System

Edge-to-edge repair with DragonFly M2 System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1.≥ 18 years old. 2.Moderate to severe (3+) or severe (4+) chronic DMR determined by transthoracic echocardiography.

• Transseptal catheterization is determined to be feasible by the Investigator.
• Patients have been informed of the nature of the study, understand the purpose of the clinical trial, voluntarily participate in the study, and sign the ICF.

Exclusion Criteria

1)Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2) The presence of other severe heart valve disease requiring surgical intervention.

3) Prior mitral valve leaflet surgery or transcatheter mitral valve intervention.

• Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
• In the judgment of the investigator, subjects may not complete the trial according to poor compliance or in other circumstances when the investigator determines that the subject is unfit to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Valgen Medtech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiangbin Pan

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Fuwai Hospital Chinese Academy of Medical Sciences

Shenzhen, Guangdong, China

Countries

China

Central Contacts

Bo Liu

Role: CONTACT

bo.liu@valgenmed.com

+86 13001980902

Xiaoxu Yang

Role: CONTACT

xiaoxu.yang@valgenmed.com

+8618910330079

Facility Contacts

Xiangbin Pan, MD, PH.D

Role: primary

+8618010155168

Other Identifiers

DragonFly-M2 01

Identifier Type: -

Identifier Source: org_study_id