Clinical Trial

DragonFly EU Pivotal Study

Recruiting
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Record status
This record was last updated November 24, 2025 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
To confirm the effectiveness and safety of the DragonFly 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 and symptomatic moderate-to- severe (3+) or severe (4+) functional mitral regurgitation subjects who remained clinically symptomatic after adequate treatment.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-06-28; most recent amendment 2025-11-19.
Status change: Not Yet Recruiting → Recruiting 2025-11-19
Trial Details
NCT Number NCT05927441
Lead Sponsor Hangzhou Valgen Medtech Co., Ltd
Collaborators: Donawa Lifescience Consulting S.r.l.
Conditions Mitral Valve Insufficiency
Enrollment 168 participants
Start Date 2024-01-01
Primary Completion 2026-04-01 (estimated)
Study Completion 2029-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-24