A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement

This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic at least severe TR in patients who are deemed high risk for tricuspid surgery. Treatment with the LuX-Valve Plus system may enable patients with tricuspid regurgitation to have a complete tricuspid valve replacement with a minimally invasive approach. Up to 150 subjects will be implanted at up to 24 institutions worldwide. No single institution will be allowed to register more than 25% of total subjects. There is no minimum number of subjects to be registered at any site. Up to3 per site, may be implanted by operators without prior experience using the LuX-Valve Plus device to gain hands-on experience.Each site has a maximum of 3 roll-in cases. The data of roll-in subjects will not count towards the overall enrollment cap. Safety and performance results of roll-in subjects will be analyzed in subgroups. All subjects will be evaluated at baseline, procedure, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure.