Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation
||Edwards Lifesciences LLC
||Male and Female Patients
|U.S. Govt. ID:
||Kate Dalton: 347-514-3366 / firstname.lastname@example.org
The goal of this early feasibility study is to gain initial insight into the basic safety and performance of transluminal (through the blood vessels) implantation of the PASCAL Systems implant (composed of man-made materials). We are trying to evaluate the safety and performance of the PASCAL System with Optimal Medical Therapy (OMT) (also known as standard of care) compared to OMT alone in participants with symptomatic severe tricuspid regurgitation who may not be ideal candidates for tricuspid valve surgery (tricuspid valve repair that is performed via open-heart surgery) and may be eligible for transcatheter tricuspid valve repair. The PASCAL Transcatheter Valve Repair System is a research option for subjects who have Tricuspid Regurgitation (TR), which is a condition in which the hearts tricuspid valve does not close tightly which causes blood to flow backwards in the incorrect direction while the heart beats. Study subjects would be required to take antiplatelet medication (which stops blood cells (called platelets) from sticking together and forming a blood clot) after the procedure and as a result, would be at an increased risk for bleeding.
Susheel Kodali, MD
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