The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).
Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.
Patient is symptomatic despite medical therapy.
The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.
The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.
Patient is currently participating in another clinical investigation that could affect the outcome of this trial.
Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.
Moderate or greater tricuspid valve stenosis.
Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
Single group
DUO Transcatheter Tricuspid Coaptation Valve System
DeviceReduction of tricuspid regurgitation through a transcatheter approach
Freedom from device or procedure related MAEs
* Death * Reintervention * Disabling stroke * Myocardial infarction * Major access site and vascular complications * Severe bleeding * Renal failure requiring dialysis * Major cardiac structural complications * Pulmonary embolism
Click on the lead sponsor to view all of their trials.
