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SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

NCT04722250 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1103

Last updated 2026-02-17

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Howard Herrmann, MD · University of Pennsylvania, United States

  • Roxana Mehran, MD · Mount Sinai School of Medicine, United States

  • Didier Tchétché, MD · Clinique Pasteur Toulouse, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-02
Primary Completion
2023-11-10
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04722250 on ClinicalTrials.gov