NCT04528576

Dragonfly-M Early Feasibility Study

Status unknown NA Last updated 29 March 2022

What this trial tests

NA trial testing Dragonfly mitral valve repair system in Mitral Regurgitation in 20 participants. Status unknown.

Timeline

23 July 2020

Primary endpoint
31 December 2022

31 December 2023

Quick facts

Lead sponsor	Hangzhou Valgen Medtech Co., Ltd
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	23 July 2020
Primary completion	31 December 2022
Estimated completion	31 December 2023
Sites	1 location across China

Drugs / interventions tested

• Dragonfly mitral valve repair system

Conditions studied

• Mitral Regurgitation — all drugs for Mitral Regurgitation →

Sponsor

Hangzhou Valgen Medtech Co., Ltd

Who can join

18 and older, any sex, with Mitral Regurgitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To establish the safety and effectiveness of the DragonFly transcatheter mitral valve repair system in symptomatic patients with moderate to severe and severe mitral regurgitation who have been determined to be at an high risk of mortality with mitral valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. First-in-Human Study of the Novel Transcatheter Mitral Valve Repair System for Mitral Regurgitation.
   Liu X, Chen M, Han Y, Pu Z, et al · · 2022 · cited 12× · PMID 36338402 · DOI 10.1016/j.jacasi.2022.03.010
2. Mitral Interventions in Heart Failure.
   Lander MM, Brener MI, Goel K, Tang PC, et al · · 2023 · cited 11× · PMID 37611988 · DOI 10.1016/j.jchf.2023.07.016