Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation

NCT07243158 | Not Yet Recruiting

• 1 other identifier: DragonFly-03
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Regurgitation Functional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Mitral regurgitation severity

  30 days, 6 months, 12 months

• Recurrent heart failure (HF) hospitalizations

  30 days, 6 months, 12 months

• NYHA Class

  30 days, 6 months, and 12 months

• Change in 6 minutes walk test distance

  12 months

• Quality of life improvement

  12 months

Other Outcomes (3)

• Incidence of adverse events

  12 months

• Incidence of major adverse events (MAEs)

  30 Days

• All-cause mortality

  12 months

Study Arms (2)

Randomized - Device Group

EXPERIMENTAL

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

Device: DragonFly System; Drug: Drug

Randomized - Control Group

ACTIVE COMPARATOR

This group will continue to be managed on medical therapy, per physician discretion

Device: DragonFly System; Drug: Drug

Interventions

DragonFly System DEVICE

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

Randomized - Control Group; Randomized - Device Group

Drug DRUG

This group will continue to be managed on medical therapy, per physician discretion

Randomized - Control Group; Randomized - Device Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hangzhou Valgen Medtech Co., Ltd: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

Pharmaceutical Preparations

Study Officials

• Jianan Wang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Liu

CONTACT

+86 13001980902; bo.liu@valgenmed.com

Xiaoxu Yang

CONTACT

+86 18910330079; xiaoxu.yang@valgenmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2030
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)