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Feasibility Study of the DragonFly-T System for Severe Tricuspid Regurgitation

NCT05671640 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-01-04

No results posted yet for this study

Summary

This study is a prospective design. Patients are severe tricuspid regurgitation (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 incidence of MAEs (Major Adverse Events) at 30 days is used as the safety endpoint. The MAEs include stroke, cardiovascular death, new renal failure, endocarditis requiring surgery, and non-elective cardiovascular interventions due to device-related adverse events.

The efficacy endpoints include acute procedural success, acute device success, the incidence of all-cause mortality and/or heart failure rehospitalization at 12 months after the procedure, 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, New York Heart Association (NYHA) class, quality of life change as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score and change in edema scale grading.

Conditions

  • Tricuspid Regurgitation

Interventions

DEVICE

DragonFly-T Transcatheter Tricuspid Valve Repair System

To conduct edge-to-edge repair with DragonFly-T System under the guidance of transesophageal echocardiography.

Sponsors & Collaborators

  • Hangzhou Valgen Medtech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jian'an Wang, MD,Phd · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-27
Primary Completion
2023-02-10
Completion
2024-01-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05671640 on ClinicalTrials.gov