At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
In Brief
A clinical study evaluating Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems and Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems for Symptomatic Aortic Stenosis and 2 related conditions. Active but no longer recruiting, targeting 1,103 participants across 92 sites in 13 countries.
Detailed 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.
Study Details
Timeline
Interventions
TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System