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Study identifier: NCT04722250 Synced from ClinicalTrials.gov · August 03, 2026
● Active Not Recruiting

SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

Condition: Symptomatic Aortic Stenosis · Aortic Valve Stenosis · Aortic Valve Replacement  ·  Sponsor: Medtronic Cardiovascular

PhaseNA
Planned participants1103
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. Additionally, a stress echocardiography sub-study will be conducted as part of the SMART Trial at select sites. The purpose of the sub-study is to evaluate performance of SE versus BE TAVR in subjects with a small aortic annulus and symptomatic severe native aortic stenosis after undergoing exercise stress echocardiographic testing.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Locations (92)

Scripps Memorial HospitalLa Jolla, California, United States
Cedars Sinai Medical CenterLos Angeles, California, United States
Sutter HealthSan Francisco, California, United States
Los Robles Hospital and Medical CenterThousand Oaks, California, United States
University of ColoradoAurora, Colorado, United States
Yale New Haven HospitalNew Haven, Connecticut, United States
WHC Washington MedStarWashington D.C., District of Columbia, United States
Morton Plant HospitalClearwater, Florida, United States
HealthPark Medical CenterFort Myers, Florida, United States
University of FloridaGainesville, Florida, United States
Mount Sinai Medical CenterMiami Beach, Florida, United States
Emory Structural Heart Clinic and Emory University MidtownAtlanta, Georgia, United States

+ 80 more locations — full list on the registry record.

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