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Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation

NCT05556460 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2024-07-19

No results posted yet for this study

Summary

The primary objective of this trial is to demonstrate the safety and effectiveness of the DragonFly-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (DragonFly-T system) to Control (Medical Therapy).

Conditions

  • Tricuspid Regurgitation

Interventions

DEVICE

DragonFly-T Transcatheter Tricuspid Valve Repair System

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

DRUG

Medical therapy

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

Sponsors & Collaborators

  • Hangzhou Valgen Medtech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jian'an Wang, MD, PH.D · 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
2024-08-15
Primary Completion
2027-08-15
Completion
2027-12-15

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 NCT05556460 on ClinicalTrials.gov