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DragonFly M2 Pivotal Study
Sponsor: Hangzhou Valgen Medtech Co., Ltd
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
Conditions
Interventions
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