Medtronic SMall Annuli Randomized To Evolut or Sapien Trial (SMART Trial)

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Medtronic SMall Annuli Randomized To Evolut or Sapien Trial (SMART Trial)

Brief description of study

The purpose of this study is to collect information and compare the safety and performance of self- expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in patients with a small aortic valve. The aortic valve is one of the four heart valves that control the flow of blood into and out of the heart. It is located in the main pumping chamber of the heart, called the left ventricle. The aortic valve allows oxygen-rich blood to be pumped out of the heart, from the left ventricle into the aorta (main artery delivering blood to the body). Aortic stenosis occurs if the valve becomes too narrow, causing less blood to flow through and the heart to have to work harder to pump the same amount of blood with each beat. As the heart works harder, the heart muscle thickens (hypertrophy), and the heart chamber (ventricle) may become larger (dilate).

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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