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Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation - Trial NCT05556460

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.

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Trial Details
ClinicalTrials.gov โ€ข NCT05556460
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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

Study Focus

Tricuspid Regurgitation

DragonFly-T Transcatheter Tricuspid Valve Repair System

Interventional

device

Sponsor & Location

Hangzhou Valgen Medtech Co., Ltd

Hangzhou, China

Timeline & Enrollment

N/A

Oct 15, 2022

Oct 15, 2028

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 โ‰ฅ 3+) who
 remained clinically symptomatic after guideline-directed medical treatment.

ICD-10 Classifications

Tricuspid stenosis
Tricuspid stenosis with insufficiency
Nonrheumatic tricuspid (valve) stenosis
Tricuspid insufficiency
Nonrheumatic tricuspid (valve) stenosis with insufficiency

Data Source

ClinicalTrials.gov

NCT05556460

Device Trial