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

Tricuspid Regurgitation Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

This study is a prospective, multicenter, objective performance criteria design. Patients are severe TR (≥ 3+) who remained clinically symptomatic after guideline-directed medical treatment. After signing an informed consent form, subjects are enrolled and treated with the DragonFly-T Transcatheter Tricuspid Valve Repair System. All subjects receive clinical follow-up immediately after the procedure, before discharge, 30 days after the procedure, 6 months after the procedure, 12 months, and 2, 3, 4, and 5 years after the procedure. The primary outcome is defined as a composite measure including all-cause mortality and recurrent heart failure hospitalization 12 months after the procedure. The secondary outcomes include acute procedural success, acute device success, the percentage of patients with tricuspid regurgitation of 2+ or less, the percentage of patients with tricuspid regurgitation reduced by at least one grade, the improvement in 6 minutes walk test distance, New York Heart Association (NYHA) class, quality of life change as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score and edema scale grading. To evaluate the safety and effectiveness of the Valgen Medtech DragonFly-T Transcatheter Tricuspid Valve Repair System in the treatment of patients with severe TR (≥ 3+) who remained clinically symptomatic after guideline-directed medical treatment,and to evaluate the product performance. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05556460
Study type Interventional
Source Hangzhou Valgen Medtech Co., Ltd
Contact Kangmu Ma
Phone +8613341773508
Email makangmu@valgenmed.com
Status Not yet recruiting
Phase N/A
Start date October 15, 2022
Completion date October 15, 2028
View Details
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