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Starting soon Not applicable

DragonFly M2 Pivotal Study

NCT07243197 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-01-15
Last updated
2025-11-21

Condition(s) studied

Mitral Valve (MV) Regurgitation

Investigational drug(s) / intervention(s)

DragonFly M2 Transcatheter Mitral Valve Repair System

DragonFly M2 Transcatheter Mitral Valve Repair System: Edge-to-edge repair with DragonFly M2 System

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1.≥ 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. Exclusion Criteria: 1)Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2) The presence of other severe heart valve disease requiring surgical intervention. 3\) 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.

Primary outcome measure(s)

  • Procedure success — 30 Days
    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.

Trial sites (1)

FacilityCityRegionStatus
Fuwai Hospital Chinese Academy of Medical Sciences Shenzhen Guangdong
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07243197 on ClinicalTrials.gov ↗ ← All trials in China