Clinical Trial

DragonFly M2 Pivotal Study

Not Yet Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated November 21, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
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 Details
NCT Number NCT07243197
Lead Sponsor Hangzhou Valgen Medtech Co., Ltd
Conditions Mitral Valve (MV) Regurgitation
Enrollment 53 participants
Start Date 2026-01-15
Primary Completion 2026-07-31 (estimated)
Study Completion 2031-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-21