Clinical Trial

SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

Study acronym: SMART
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 39 amendments
This ClinicalTrials.gov record has been amended 39 times since 2021-01-22; most recent amendment 2026-05-29.
Status change: Recruiting → Active, Not Recruiting 2022-11-04
Status change: Not Yet Recruiting → Recruiting 2021-04-28
Trial Details
NCT Number NCT04722250
Lead Sponsor Medtronic Cardiovascular
Conditions Symptomatic Aortic Stenosis, Aortic Valve Stenosis, Aortic Valve Replacement
Enrollment 1,103 participants
Start Date 2021-04-02
Primary Completion 2023-11-10 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-02