NCT04722250

SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,103 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multi-center, international, randomized controlled, post-market trial. The primary objectives of the trial are to demonstrate clinical non-inferiority and hemodynamic superiority of the Evolut PRO/PRO+/FX System when compared to subjects treated with the SAPIEN 3/3 Ultra System at 12 months post-procedure. Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE Transcatheter Aortic Valve (TAV) or an Edwards BE Transcatheter Heart Valve (THV). Data will be collected at pre- and post-procedure, at discharge, at 30 days, and once a year until the 5-year follow-up is completed. Product Names: * Medtronic Evolut PRO and Evolut PRO+ TAV Systems, Evolut FX System (Commercially available in the United States and may be used upon commercial availability in Canada.) * Edwards SAPIEN 3 and SAPIEN 3 Ultra THV Systems The exercise stress echocardiographic testing at select SMART Trial sites seeks to evaluate the performance of the prosthetic aortic valve during exercise. The stress echocardiogram assessment will be conducted as part of the 12-month visit for participating subjects.

Conditions

• Symptomatic Aortic Stenosis
• Aortic Valve Stenosis
• Aortic Valve Replacement

Interventions

Type	Name	Description
DEVICE	Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems	TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
DEVICE	Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems	TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Timeline

• Start date: 2021-04-02
• Primary completion: 2023-11-10
• Completion: 2027-12-01
• First posted: 2021-01-25
• Last updated: 2026-02-17
• Results posted: 2025-03-20

Locations

92 sites across 13 countries: United States, Canada, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study