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.