Clinical Trial

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

Recruiting
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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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-09-23; most recent amendment 2026-06-10.
Status change: Not Yet Recruiting → Recruiting 2024-07-18
Trial Details
NCT Number NCT05556460
Lead Sponsor Hangzhou Valgen Medtech Co., Ltd
Conditions Tricuspid Regurgitation
Enrollment 236 participants
Start Date 2024-09-03
Primary Completion 2028-08-15 (estimated)
Study Completion 2032-08-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-12