DragonFly M2 Pivotal Study
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences | Shenzhen | Guangdong |
More Hangzhou Valgen Medtech Co., Ltd trials in China
Other trials for the same condition
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