Feasibility Study of Dragonfly System for Severe Tricuspid Regurgitation

Tricuspid Regurgitation Clinical Trial

Official title: A Clinical Study of Management of Severe Tricuspid Regurgitation With Transcatheter Mitral Valve Clamping System

Status Enrolling by invitation

Clinical Trial Summary

The study is designed to assess the feasibility of the DragonFly transcatheter mitral valve clamping system for the treatment of symptomatic severe tricuspid regurgitation.

Clinical Trial Description

This study is a prospective, single-center design. Patients are clinically symptomatic patients with severe tricuspid regurgitation despite medical therapy with an expected moderate or greater surgical risk and prohibited to thoracotomy. After signing an informed consent form, subjects are enrolled and treated with the DragonFly Transcatheter Mitral Valve Repair System. All subjects receive clinical follow-up immediately after the procedure, before discharge, and 30 days, 6 months, 12 months and 24 months after the procedure. Incidence of MAEs at 30 days and immediate procedural success is used as the primary endpoint. The MAEs include device- or procedure-related death, myocardial infarction, stroke, renal failure, and nonelective cardiovascular surgery associated with adverse events. The immediate procedural success is defined as successful implantation of a tricuspid valve-clamp device with at least a one-grade reduction in severity of tricuspid regurgitation at discharge (30-day echocardiography if discharge records were not available or were uninterpretable). Subjects who died or underwent tricuspid valve surgery prior to discharge were defined as immediate procedure failure. The secondary endpoints include all-cause mortality, cardiovascular-related mortality, the incidence of serious adverse events, heart failure rehospitalization, changes of NYHA classification, reduction of tricuspid regurgitation severity, the proportion of reoperations, changes of quality of life as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) score. The study comprises two main objectives, firstly, to assess the safety and effectiveness of the DragonFly transcatheter mitral valve clamping system for the treatment of symptomatic severe tricuspid regurgitation despite medical therapy with an expected moderate or greater surgical risk and prohibited to thoracotomy. Secondly, to evaluate the feasibility and performance of the device and to familiarize clinicians with the device and procedure. ;

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

• NCT number: NCT04921605
• Study type: Interventional
• Source: Hangzhou Valgen Medtech Co., Ltd
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 15, 2020
• Completion date: June 15, 2023