NCT07243158

Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Hangzhou Valgen Medtech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective, multicenter, randomized controlled design. Patients are chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment. After signing an informed consent form, subjects in the experimental group will undergo the transcatheter mitral valve repair procedure using the DragonFly™ Transcatheter Mitral Valve Clip System . According to the investigator's discretion, all subjects in the treatment group will continue to receive maximally tolerated guideline-directed medical therapy (GDMT). Subjects in the control group will also continue maximally tolerated GDMT as determined by the investigator. After completing the 12-month follow-up, crossover to the treatment group will be permitted. All subjects were followed up before discharge (excluding the control group), and 30 days, 6 months, 12 months, and 24 months after treatment. Subjects in the experimental group and those who crossed over to the experimental group underwent extended clinical follow-up for 3, 4, and 5 years.

Conditions

• Mitral Regurgitation Functional

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-30
• Primary completion: 2027-06-30
• Completion: 2030-06-30
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: China