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Safety and Effectiveness Study of Dragonfly System for Functional Mitral Regurgitation

NCT04733404 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-03-29

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 guideline-directed medical treatment.

Conditions

  • Mitral Regurgitation Functional

Interventions

DEVICE

Dragonfly Transcatheter Mitral Valve Repair System

To conduct edge-to-edge repair with Dragonfly System under the guidance of transesophageal echocardiography.

Sponsors & Collaborators

  • Hangzhou Valgen Medtech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jianan Wang, MD, PH.D · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-12
Primary Completion
2023-09-30
Completion
2027-09-30

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 NCT04733404 on ClinicalTrials.gov