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Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
Sponsor: Hangzhou Valgen Medtech Co., Ltd
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
Conditions
Interventions
DragonFly-T Transcatheter Tricuspid Valve Repair System
To conduct edge-to-edge repair with DragonFly-T System under the guidance of transesophageal echocardiography.
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