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Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation
Sponsor: Hangzhou Valgen Medtech Co., Ltd
Summary
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after adequate treatment.
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of the DragonFly Transcatheter Mitral Valve Clip System in the Treatment of Moderate-to-Severe or Severe Functional Mitral Regurgitation (FMR)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
148
Start Date
2025-12-30
Completion Date
2030-06-30
Last Updated
2025-11-21
Healthy Volunteers
No
Conditions
Interventions
DragonFly System
This group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.
Drug
This group will continue to be managed on medical therapy, per physician discretion
Locations (1)
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China