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NOT YET RECRUITING
NCT07243197
NA

DragonFly M2 Pivotal Study

Sponsor: Hangzhou Valgen Medtech Co., Ltd

View on ClinicalTrials.gov

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.

Official title: Safety and Performance Evaluation Study of DragonFly M2 System for Mitral Regurgitation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2026-01-15

Completion Date

2031-06-30

Last Updated

2025-11-21

Healthy Volunteers

No

Interventions

DEVICE

DragonFly M2 Transcatheter Mitral Valve Repair System

Edge-to-edge repair with DragonFly M2 System

Locations (1)

Fuwai Hospital Chinese Academy of Medical Sciences

Shenzhen, Guangdong, China