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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mitral Regurgitation Functional
• Intervention / Treatment: Device: DragonFly System; Drug: Drug

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.

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bo Liu; Phone Number: +86 13001980902; Email: bo.liu@valgenmed.com
• Study Contact Backup: Name: Xiaoxu Yang; Phone Number: +86 18910330079; Email: xiaoxu.yang@valgenmed.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • the Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Jianan Wang, MD, PH.D; Phone Number: +8613805786328; Email: wja@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomized - Device Group; This group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.	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
Active Comparator: Randomized - Control Group; This group will continue to be managed on medical therapy, per physician discretion	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success at 12 months after the procedure	The rate of the composite endpoint of freedom from all-cause mortality, hospitalization for heart failure, NYHA improved <1 class and MR > 2+ at 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mitral regurgitation severity	Percentage of patients with mitral regurgitation of 2+ or less.	30 days, 6 months, 12 months
Recurrent heart failure (HF) hospitalizations	Number of patients with incidence of re-hospitalizations for heart failure after Dragonfly implantation.	30 days, 6 months, 12 months
NYHA Class	Number of patients with New York Heart Association (NYHA) Function Class I or II.	30 days, 6 months, and 12 months
Change in 6 minutes walk test distance	Improvement in 6 Minute Walk Test distance at 12 months over baseline.	12 months
Quality of life improvement	Improvement in quality of life (QoL) at 12 months over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).	12 months
Left Ventricular End Diastolic Volume (LVEDV)	Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).	12 months
Acute procedural success（only for experimental group）	Successful in Dragonfly implantation, and residual MR of 2+ or less at discharge. An echocardiography echocardiogram at 30 days can be accepted if the discharge image was not available or hard to interpret. A death before discharge or a re-operation of mitral valve prior to 30 days is defined as acute procedure failure.	Immediately after procedure, Discharge: The day after the patient's exit from the cardiac catheterization laboratory
Acute device success（only for experimental group）	One or more Dragonfly devices are successfully delivered and released, edge-to-edge leaflet repair confirmed by echocardiogram, and successfully withdrawal of the delivery catheter.	Immediately after procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	MAE is defined as a combined clinical endpoint of single leaflet device attachment (SLDA), device embolization, endocarditis requiring surgery, mitral stenosis confirmed by the echocardiographic core laboratory requiring surgical intervention, left ventricular assist device (LVAD) implantation, heart transplantation, and nonelective cardiovascular surgery for device or procedure-related adverse events occurring after transseptal catheterization.（only for experimental group）	12 months
Incidence of major adverse events (MAEs)	MAE is defined as a combined clinical endpoint of death, stroke, myocardial infarction, and nonelective cardiovascular surgery for device or procedure-related adverse events occurring after transseptal catheterization.（only for experimental group）	30 Days
All-cause mortality	Percentage of all-cause death includes cardiac death, non-cardiac death, and death from unknown causes.	12 months

Collaborators and Investigators

• Sponsor: Hangzhou Valgen Medtech Co., Ltd
• Investigators: Principal Investigator: Jianan Wang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Preparations
• Other Study ID Numbers: DragonFly-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No