Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou Valgen Medtech Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

Transseptal catheterization and femoral vein access is determined to be feasible.

The subject or subject's legal representative has been informed of the nature of the trial, willing to accept the experimental tests, and has provided written informed consent.

Disqualifiers

Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.

In the judgment of the investigator, subjects may not complete the trial according to poor compliance or in other circumstances when the investigator determines that the subject is unfit to participate in the study.

Trial design

Treatments tested in this trial

  • DragonFly System
  • Drug

Treatment groups

148 Participants
are divided into 2 treatment groups