Feasibility Study of Dragonfly System for Severe Tricuspid Regurgitation

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

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

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.