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

Conditions studied

Tricuspid Regurgitation (TR)

What is being tested

• DEVICE: Transcatheter Tricuspid Valve Intervention

What it measures

• Primary Outcome - Incidence of major adverse events at 30 days post procedure, A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure, as listed below: * Cardiovascular Death * Myocardial Infarction (MI) * Stroke * New Onset Renal Failure Requiring Unplanned Dialysis or Hemofiltration * Major Bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium \[TVARC\]) * Tricuspid Valve Surgery or Transcatheter Re-intervention post Procedure * Major Access Site and Vascular Complications * Major Cardiac Complications * Device-related Pulmonary Embolism * New Pacemaker Implantation due to Atrioventricular (AV) Block, at 30 days post procedure
• Primary Outcome - Post-procedural TR Remission Rate, Defined as: Post-procedural TR of moderate or less (TR≤2+) without clinically significant paravalvular leak (PVL) on a transthoracic echocardiography (TTE) at 30 days post- procedure (Assessed by the Echocardiography Core Lab using a 5-grade classification), at 30 days post procedure

Working with

Cardiovascular Research Foundation, New York