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RECRUITING
NCT05556460
NA

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

Sponsor: Hangzhou Valgen Medtech Co., Ltd

View on ClinicalTrials.gov

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).

Official title: A Prospective, Multicenter, Parallel, Randomized Controlled Study to Evaluate the Safety and Effectiveness of the DragonFly-T Transcatheter Tricuspid Valve Clip System in the Treatment of Tricuspid Regurgitation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

236

Start Date

2024-08-15

Completion Date

2027-12-15

Last Updated

2024-07-19

Healthy Volunteers

No

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

Locations (2)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China