NCT07243197

DragonFly M2 Pivotal Study

Safety and Performance Evaluation Study of DragonFly M2 System for Mitral Regurgitation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Hangzhou Valgen Medtech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multicentric clinical investigation. Subjects to be included in this clinical investigation suffer from symptomatic chronic moderate-to-severe (3+) or severe (4+) DMR with high or prohibitive surgical risk judged by a local investigation site's heart team . After signing an informed consent form, subjects in the experimental group will undergo the transcatheter mitral valve repair procedure using the DragonFly M2 Transcatheter Mitral Valve Clip System. All subjects were followed up immediately after procedure, before discharge, 30 days , 6 months, 12 months after procedure, and 2, 3, 4, and 5 years after procedure.

Conditions

• Mitral Valve (MV) Regurgitation

Interventions

Type	Name	Description
DEVICE	DragonFly M2 Transcatheter Mitral Valve Repair System	Edge-to-edge repair with DragonFly M2 System

Timeline

• Start date: 2026-01-15
• Primary completion: 2026-07-31
• Completion: 2031-06-30
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: China