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NCT05556460

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

A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Safety and Effectiveness of DragonFly-T Transcatheter Tricuspid Valve Repair System for the Treatment of Tricuspid Regurgitation Subjects
Hangzhou Valgen Medtech Co., Ltd·ClinicalTrials.gov·device·Device trialNot yet recruiting
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Study focus
Disease/Condition
Tricuspid Regurgitation
Drug/Device/Intervention
DragonFly-T Transcatheter Tricuspid Valve Repair System
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Hangzhou Valgen Medtech Co., Ltd
Location
Hangzhou, China
Timeline & enrollment
Phase
N/A
Start date
Oct 15, 2022
End date
Oct 15, 2028
Enrollment
151 participants
Primary outcome

Number of patients with composite measures- All-cause death and recurrent HF hospitalizations.

Summary

To confirm the effectiveness and safety of the DragonFly-T transcatheter tricuspid valve
 repair system for the treatment of severe tricuspid regurgitation (TR) (TR grade ≥ 3+) who
 remained clinically symptomatic after guideline-directed medical treatment.

ICD-10 classifications
Tricuspid stenosisTricuspid stenosis with insufficiencyNonrheumatic tricuspid (valve) stenosisTricuspid insufficiencyNonrheumatic tricuspid (valve) stenosis with insufficiency
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05556460
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05556460 through Pure Global AI's free database. This phase not specified trial is sponsored by Hangzhou Valgen Medtech Co., Ltd and is currently Not yet recruiting. The study focuses on Tricuspid Regurgitation. Target enrollment is 151 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.