TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First in Human Trial
The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
• Subject of age \>18 years.
• Subject with severe symptomatic tricuspid regurgitation presenting following conditions:
‣ TR severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or
⁃ symptoms requiring use of diuretics.
• Subject presenting with New York Heart Association Class NYHA ≥II.
• Subject is not eligible for open tricuspid valve surgery due to high operative risk, as determined by a Heart Team decision.