NCT05927441

DragonFly EU Pivotal Study

Safety and Performance Evaluation Study of DragonFly System for Mitral Regurgitation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (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 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.

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 and symptomatic moderate-to- severe (3+) or severe (4+) functional mitral regurgitation subjects who remained clinically symptomatic after adequate treatment. Local heart teams must include at a minimum a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease. After signing the informed consent form (ICF), a subject will be enrolled and treated with the DragonFlyTM Transcatheter Mitral Valve Repair System (Valgen Medtech, Hangzhou). The CE-DMR cohort clinical investigation will be assessed at the following intervals: implant, before discharge, 30 days, 6 months and annually for 5 years. Group sequential design analysis is planned based on an adaptive design to assess whether the primary endpoint will be met. If the primary endpoint is not met at the interim analysis, then it will be re-analyzed for 160 patients when all subjects in Europe/Canada complete 12 months follow-up. The CE-FMR cohort clinical investigation will be assessed at the following intervals: implant, before discharge, 30 days, 6 months and annually for 5 years. An adaptive design with sample size re-estimation will be incorporated. The primary endpoint will be assessed at the interim analysis. If the conditional power falls within the promising zone (38-80%), then the sample size will be re-estimated to maintain at least 80% power. Then the primary endpoint will be evaluated once the 12-month follow-up is completed with the larger sample size (not less than 165).

Conditions

• Mitral Valve Insufficiency

Interventions

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

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-04-01
• Completion: 2029-05-01
• First posted: 2023-07-03
• Last updated: 2025-11-24

Locations

1 site across 1 country: Germany