Endpoints
The primary endpoint of the study was overall mortality at one and twelve months. Cardiac mortality and procedural results were also considered at the same time points. Device success and the clinical safety endpoint were evaluated and determined according to the Valve Academic Research Consortium-2 (VARC-2) criteria 13. Other endpoints included device-related complications, and echocardiographic assessment of the valve and cardiac function at post-procedure. The severity of the PVL was qualitatively assessed and graded using TTE 14.
Study device and TAVR Procedure.