TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US)

Investigational Device: The LuX-Valve Plus System consists of the following elements: 1. a bioprosthetic valve consistent of bovine pericardial tissue mounted on a self-expanding nitinol stent frame (hereafter referred to as LuX-Valve Implant).The LuX-Valve Implant consists of a trileaflet bovine-pericardial-tissue valve, a nitinol self-expanding stent, a fabric skirt, a pair of clips, an anchoring pin and sutures. 2. a catheter-based delivery system (hereafter referred to as LuX-Valve Delivery Device), 3. an Introducer Kit for transvenous access, and 4. a delivery system Stabilizer. * The LuX-Valve Implant sizes: o JS/TTVI-28-40, JS/TTVI-28-45, JS/TTVI-28-50, JS/TTVI- 28-55, JS/TTVI-30-40, JS/TTVI-30-45, JS/TTVI-30-50, JS/TTVI-30-55, JS/ TTVI-30-60, JS/TTVI-30-65 * LuX--Valve Plus Delivery System o JS/TTVDJ-33 * Introducer Kit o JS/SID01-33-100 * Stabilizer o JS/STA-TJ01-01 Primary Objective: To assess the safety and effectiveness of the LuX-Valve Plus System in patients with at least severe tricuspid regurgitation (TR) who are at high risk for surgical treatment. Study Sites and Geography: Up to 3 centers in the United States. Number of Subjects: Up to 15 subjects will be enrolled. Indications for Use: The LuX-Valve Plus System is intended for the improvement of health status in patients with at least severe TR who are symptomatic and determined by a Heart Team to be at high risk for surgical treatment.