NCT07243197

Brief Summary

To confirm the effectiveness and safety of the DragonFly M2 Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects.The safety and effectiveness of the first-generation device(Dragonfly Transcatheter Mitral Valve Repair System)have been previously demonstrated. This study aims to further confirm the safety and effectiveness of the new device following structural optimization based on the first-generation design.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
62mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jan 2026Jun 2031

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2031

Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Mitral Valve (MV) Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Procedure success

    Procedure success: device implanted successfully, MR ≤ 2+ at discharge (or 30-day echo if unavailable), and no death or device-related reintervention within 30 days post-procedure.

    30 Days

Secondary Outcomes (5)

  • Single-click release success

    Intraoperative

  • Acute device success

    Immediately after procedure

  • surgical intervention

    30 days, 6 months, and 12 months

  • NYHA Class

    30 days, 6 months, and 12 months

  • Quality of life improvement

    30 days, 6 months, and 12 months

Other Outcomes (3)

  • Incidence of major adverse events (MAEs)

    30 days, 6 months, and 12 months

  • All-cause mortality

    30 days, 6 months, and 12 months

  • Cardiovascular death

    30 Days, 6 months, 12 months

Study Arms (1)

DragonFly M2 Transcatheter Mitral Valve Repair System

EXPERIMENTAL

Transcatheter mitral valve repair with the DragonFly M2 System in patients with degenerative mitral regurgitation

Device: DragonFly M2 Transcatheter Mitral Valve Repair System

Interventions

DragonFly M2 Transcatheter Mitral Valve Repair SystemDEVICE

Edge-to-edge repair with DragonFly M2 System

DragonFly M2 Transcatheter Mitral Valve Repair System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years old. 2.Moderate to severe (3+) or severe (4+) chronic DMR determined by transthoracic echocardiography.
  • Transseptal catheterization is determined to be feasible by the Investigator.
  • Patients have been informed of the nature of the study, understand the purpose of the clinical trial, voluntarily participate in the study, and sign the ICF.

You may not qualify if:

  • )Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2) The presence of other severe heart valve disease requiring surgical intervention.
  • \) Prior mitral valve leaflet surgery or transcatheter mitral valve 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital Chinese Academy of Medical Sciences

Shenzhen, Guangdong, 518000, China

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Xiangbin Pan

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Liu

CONTACT

+86 13001980902bo.liu@valgenmed.com

Xiaoxu Yang

CONTACT

+8618910330079xiaoxu.yang@valgenmed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start

January 15, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

June 30, 2031

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)