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).
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
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.
Parallel
DragonFly-T Transcatheter Tricuspid Valve Repair System
DeviceTo conduct edge-to-edge repair with DragonFly-T System under the guidance of transesophageal echocardiography.
Medical therapy
DrugSubjects will continue to be managed on medical therapy, per physician discretion
Hierarchical Composite of All-cause Death or Tricuspid Valve Intervention, Heart Failure Hospitalizations, and KCCQ Improvement
Tricuspid regurgitation severity
Percentage of patients with tricuspid regurgitation of 2+ or less.
Change in 6 minutes walk test distance
Improvement in 6 Minute Walk Test distance
Quality of life improvement
Improvement in quality of life (QoL) , as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Acute procedural success
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