Actively Recruiting
Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
Led by Hangzhou Valgen Medtech Co., Ltd · Updated on 2024-07-19
236
Participants Needed
2
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this trial is to demonstrate the safety and effectiveness of the DragonFly-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (DragonFly-T system) to Control (Medical Therapy).
CONDITIONS
Official Title
Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patient has been adequately treated and stable for at least 30 days
- Symptoms of tricuspid regurgitation despite optimized drug treatment
- Determined to be at intermediate or higher risk for tricuspid valve surgery
- New York Heart Association (NYHA) Cardiac function Class II-IVa
- Suitable for transcatheter tricuspid valve repair and femoral vein access
- Provided written informed consent before study participation
You will not qualify if you...
- Tricuspid valve leaflet anatomy preventing clip implantation or proper positioning, including calcification, severe coaptation defect, severe leaflet defects or clefts, and Epstein anomaly
- Other serious heart valve diseases requiring intervention within 12 months
- Tricuspid stenosis with cross-tricuspid pressure gradient ≥ 5 mmHg
- Previous tricuspid valve surgery or transcatheter therapy
- Presence of intracardiac thrombus, tumor, mass, or implants/thrombus in femoral vein or inferior vena cava
- Inability to evaluate tricuspid valve anatomy by TTE or TEE
- Participation in other drug or device clinical trials within 1 month prior
- Any condition deemed inappropriate for study enrollment by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
2
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
B
Bo Liu
CONTACT
S
Shuangjie Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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