About the Trial
The purpose of the SMART (SMall Annuli Randomized To Evolut or SAPIEN) Trial is to generate clinical evidence on the safety and performance of the Evolut PRO/PRO+ self-expanding (SE) transcatheter aortic valve replacement (TAVR) system versus the SAPIEN 3/3 Ultra balloon-expandable (BE) TAVR system in subjects with small aortic annulus and symptomatic severe native aortic stenosis.
Subjects will be randomized on a 1:1 basis to receive either an Evolut PRO/Evolut PRO+ SE TAV or a SAPIEN 3/SAPIEN 3 Ultra BE TAV.
Approximately 700 treated subjects at approximately 90 sites in Canada, Europe, and the United States.
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