2019-06 TRISCEND Study

Conditions studied

Cardiovascular Diseases, Heart Valve Diseases, Tricuspid Valve Regurgitation

What is being tested

• DEVICE: Transcatheter Tricuspid Valve Replacement

What it measures

• Clinical Success, Procedural success without MAEs at 30 days., 30 Days
• Composite Major Adverse Events (MAEs), Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency tricuspid valve re-intervention, major access site and vascular complications, major access site and vascular complications, and device-related pulmonary embolism at 30 days., 30 Days
• Device Success, Study device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory., Intraprocedural
• Procedure Success, Device success without clinically significant paravalvular leak (PVL) on a transthoracic echocardiogram (assessed by the echo core lab) at time of discharge., Discharge (Up to 7 days post procedure)
• Tricuspid Regurgitation Reduction, Percentage of patients with at least 1 grade reduction in tricuspid regurgitation (TR) as measured by using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory., Discharge (Up to 7 days post procedure)