TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation - SafetY and Clinical Performance
The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are symptomatic and determined by a Heart Team not to be suitable for surgical treatment. This study aims to assess the safety and effectiveness of the LuX-Valve Plus System in high-surgical risk patients with at least severe tricuspid regurgitation (TR).
• Age ≥18 years at time of consent
• Severe or greater TR assessed on transthoracic echocardiography by Echocardiography Core Lab using a 5-grade classification (Mild, Moderate, Severe, Massive, Torrential).
• New York Heart Association (NYHA) Class II-IV
• The Patient is being treated on optimal dosage for diuretics at investigator discretion
• The Site Heart Team concur the patient is not an optimal candidate for surgical treatment and it is anatomically suitable for transcatheter tricuspid valve replacement
• Patient must be able to fully understand all aspects of the investigation that are relevant to the decision to participate and provide a written informed consent
• Anatomical inclusion criteria confirmed by echocardiographic core lab, CT core lab and Eligibility Committee