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Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation

NCT07243158 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2025-11-21

No results posted yet for this 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.

Conditions

  • Mitral Regurgitation Functional

Interventions

DEVICE

DragonFly System

This group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.

DRUG

Drug

This group will continue to be managed on medical therapy, per physician discretion

Sponsors & Collaborators

  • Hangzhou Valgen Medtech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jianan Wang · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-30
Primary Completion
2027-06-30
Completion
2030-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07243158 on ClinicalTrials.gov