Menu
Not yet recruiting NCT07243158

Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation

No phase Interventional Mitral Regurgitation Functional

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DragonFly System, Drug.
Who it may be relevant to
Registry conditions: Mitral Regurgitation Functional. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

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

Primary outcome measures

  • Clinical success at 12 months after the procedure [Time frame: 12 months]
Secondary outcome measures (8)
  • Mitral regurgitation severity [Time frame: 30 days, 6 months, 12 months]
  • Recurrent heart failure (HF) hospitalizations [Time frame: 30 days, 6 months, 12 months]
  • NYHA Class [Time frame: 30 days, 6 months, and 12 months]
  • Change in 6 minutes walk test distance [Time frame: 12 months]
  • Quality of life improvement [Time frame: 12 months]
  • Left Ventricular End Diastolic Volume (LVEDV) [Time frame: 12 months]
  • Acute procedural success（only for experimental group） [Time frame: Immediately after procedure, Discharge: The day after the patient's exit from the cardiac catheterization laboratory]
  • Acute device success（only for experimental group） [Time frame: Immediately after procedure]

Eligibility criteria

Inclusion criteria

1\) Age ≥ 18 yrs. 2) Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy

  • 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.

Exclusion criteria

1\) Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2）Echocardiography revealed severe restriction of leaflet motion due to tethering.

3\) The presence of other severe heart valve disease requiring surgical intervention.

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07243158 · DragonFly-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗