TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study

Brief description of study

This study will evaluate the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System (hereinafter referred to as the PASCAL System) in patients with tricuspid regurgitation who are determined to be potential candidates for transcatheter tricuspid valve repair. . This is an investigational device system, which means the safety, and effectiveness of this device for treatment of your condition is unknown and has not been approved for commercial use by the U.S. Food and Drug Administration (FDA).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 System’s implant (composed of man-made materials). This study is being conducted in up to 30 US centers (pending FDA approval). Early feasibility studies are now being used within the United States to evaluate innovative devices but there may be unforeseeable risks associated with participation in an early feasibility study due to limitations in available data and experience with the device.




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