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Dragonfly-M Early Feasibility Study

NCT04528576 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-03-29

No results posted yet for this study

Summary

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

Conditions

  • Mitral Regurgitation

Interventions

DEVICE

Dragonfly mitral valve repair system

With transesophageal echocardiographic guidance,implanting clip using Dragonfly mitral valve repair system

Sponsors & Collaborators

  • Hangzhou Valgen Medtech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • jianan Wang, PhD · 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
2020-07-23
Primary Completion
2022-12-31
Completion
2023-12-31

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 NCT04528576 on ClinicalTrials.gov