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DragonFly M2 Pivotal Study

NCT07243197 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-11-21

No results posted yet for this study

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.

Conditions

  • Mitral Valve (MV) Regurgitation

Interventions

DEVICE

DragonFly M2 Transcatheter Mitral Valve Repair System

Edge-to-edge repair with DragonFly M2 System

Sponsors & Collaborators

  • Hangzhou Valgen Medtech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Xiangbin Pan · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2026-07-31
Completion
2031-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07243197 on ClinicalTrials.gov