SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial)

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SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial)

Brief description of study

The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding versus balloon-expandable transcatheter aortic valve replacement in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. The devices that will be evaluated in the study are currently being used per standard of care. They are commercially available. The main goal of the study is to evaluate which device is better for treating patients with a small aortic annulus.

Clinical Study Identifier: s21-00367

ClinicalTrials.gov Identifier: NCT04722250

Principal Investigator: Mathew R. Williams.

Other Investigators: Larry A Chinitz, Muhamed Saric, Daniel G Bamira, Siarhei Novik, Cezar S Staniloae, Richard Ro.

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