Tricuspid Regurgitation Clinical Trial
Official title:
A Prospective, Multicenter, Randomized, Clinical Trial of the TricValve Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation (TR).
The Investigational Device is the TricValve Transcatheter Bicaval Valve System (also referred to as the TricValve System). The bioprosthesis is available in two different diameters for each model (SVC and IVC) specifically designed to adapt to the anatomic features of the superior and inferior vena cava. The SVC and IVC valves are single use, sterile devices provided in two sizes each, for a total of four valve sizes. The valves are designed for heterotopic caval implantation without perturbing the native tricuspid valve. The valves are made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system. The SVC and IVC valves are provided pre-mounted in two separate TricValve Delivery Systems, and are individually packaged into two separate boxes, provided sterile and ready to use. The two TricValve Delivery Systems deliver the two valves percutaneously into the SVC and IVC via femoral vein access using a transvenous approach.
This is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the TricValve System with OMT compared to OMT alone in the treatment of patients with severe TR and caval reflux. The TricValve System received Breakthrough Device Designation from the US FDA. ;
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