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NOT YET RECRUITING
NCT07243158
NA

Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation

Sponsor: Hangzhou Valgen Medtech Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DEVICE

DragonFly System

This group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.

DRUG

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