102
Participants
Start Date
May 10, 2017
Primary Completion Date
February 22, 2022
Study Completion Date
May 31, 2024
TAVI_ViV procedure with Edwards valve
The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local anesthesia, imaging guidance during the TAVI procedure, and post-procedural TAVI management. The decision for selecting either a 20 or 23mm Edwards valve will be based on 3D CT measurements of the mean inner diameter of the surgical aortic bioprosthesis. A 23mm Sapien 3 valve will be recommended if the inner diameter is \>18 mm, and a 20mm valve will be selected if the mean inner diameter is ≤18 mm.
TAVI_ViV procedure with CoreValve system
The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local anesthesia, imaging guidance during the TAVI procedure, and post-procedural TAVI management. A 23mm valve will be recommended in all patients randomized to the self-expanding CoreValve Evolut R system.
IUCPQ, Québec
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
OTHER