Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
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
Hangzhou Valgen Medtech Co., Ltd
236 participants
Sep 3, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
To conduct edge-to-edge repair with DragonFly-T System under the guidance of transesophageal echocardiography.
Subjects will continue to be managed on medical therapy, per physician discretion
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05556460