Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation
Condition(s) studied
Investigational drug(s) / intervention(s)
DragonFly System: This group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.
Drug: This group will continue to be managed on medical therapy, per physician discretion
Study summary
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after adequate treatment.
Eligibility
Primary outcome measure(s)
- Clinical success at 12 months after the procedure — 12 months
The rate of the composite endpoint of freedom from all-cause mortality, hospitalization for heart failure, NYHA improved \<1 class and MR \> 2+ at 12 months.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang |
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 NCT07243158 on ClinicalTrials.gov ↗ ← All trials in China