Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
A Prospective, Multicenter, Parallel, Randomized Controlled Study to Evaluate the Safety and Effectiveness of the DragonFly-T Transcatheter Tricuspid Valve Clip System in the Treatment of Tricuspid Regurgitation
Hangzhou Valgen Medtech Co., Ltd
236 participants
Aug 15, 2024
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria6
- Age ≥ 18 years
- In the judgment of the local cardiac team, the patient has been adequately treated according to applicable standards (including medical management)and has been stable for at least 30 days.
- Despite the drug optimization treatment according to the above method, patients still have symptoms of TR;
- Determined by the local cardiac team to be at intermediate or higher risk for tricuspid valve surgery
- New York Heart Association (NYHA) Cardiac function Class II-IVa;
- \. The patient is suitable for transcatheter tricuspid valve repair, suitable for the use of this study instrument, and the femoral vein access is feasible and can accommodate catheter; 6. Patient must provide written informed consent before any steps related to the study.
Exclusion Criteria11
- Tricuspid valve leaflet anatomy, which may preclude clip implantation, proper clip positioning on the leaflets, including but not limited to the following:
- Evidence of calcification in the grasping area;
- Presence of a severe coaptation defect of the tricuspid leaflets;
- Severe leaflet defect(s) and cleft preventing proper device placement determined by ECL;
- Epstein anomaly.
- Other serious heart valvular diseases requiring intervention or planning to intervention in the next 12 months; Note: If mitral and tricuspid valve lesions are combined, mitral valve surgery can be performed first, and re-evaluation can be performed 60 days after surgery.
- Tricuspid stenosis evaluated by ECL and/or cross-tricuspid differential pressure ≥ 5 mmHg;
- Previous tricuspid valve surgery or transcatheter therapy;
- Echocardiography suggested intracardiac thrombus, tumor or mass, or femoral vein and inferior vena cava implants or thrombus;
- TTE and TEE are unable to evaluate tricuspid valve anatomy; Participated in any drug and/or medical device clinical trials within 1 month prior to the trial; ……
- \. The researchers do not consider it appropriate to be enrolled in the study.
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Interventions
To conduct edge-to-edge repair with DragonFly-T System under the guidance of transesophageal echocardiography.
Subjects will continue to be managed on medical therapy, per physician discretion
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05556460