The SMART Trial Is Now Enrolling

This clinical trial aims to demonstrate the clinical non-inferiority and hemodynamic superiority of the commercially available Evolut™ PRO/PRO+ system compared to the commercially available SAPIEN™* 3/3 Ultra system at 12 months post-procedure.

LEARN ABOUT SMART
Graphic illustration of a checklist regarding a patient’s eligibility criteria for the SMART Trial.

Eligibility Criteria

Find out about patient’s eligibility criteria for the SMART Trial.
Graphic illustration of a map for clinical trial locations for the SMART Trial.

Clinical Trial Locations

For details about locations for the SMART Trial, visit clinicaltrials.gov using identifier number NCT04722250.

About the Trial

The purpose of the SMART (SMall Annuli Randomized To Evolut or SAPIEN) Trial is to generate clinical evidence on the safety and performance of the Evolut PRO/PRO+ self-expanding (SE) transcatheter aortic valve replacement (TAVR) system versus the SAPIEN 3/3 Ultra balloon-expandable (BE) TAVR system in subjects with small aortic annulus and symptomatic severe native aortic stenosis.
 
Subjects will be randomized on a 1:1 basis to receive either an Evolut PRO/Evolut PRO+ SE TAV or a SAPIEN 3/SAPIEN 3 Ultra BE TAV.

SMART Trial Synopsis

Graphic illustration of the SMART Trial process, including CT scan, risk assessment, heart team evaluation and randomization on 1:1 basis.

Sample Size

Approximately 700 treated subjects at approximately 90 sites in Canada, Europe, and the United States.

Primary Endpoints

  • A clinical composite endpoint of mortality, disabling stroke, or rehospitalization (valve-related or heart failure) at 12 months.
  • A valve function composite endpoint of bioprosthetic valve dysfunction (BVD) at 12 months including any of the following:

    • Hemodynamic structural valve dysfunction (HSVD): hemodynamic mean gradient
      ≥ 20 mm Hg
    • Nonstructural valve dysfunction (NSVD): severe prosthesis-patient mismatch (PPM),
      ≥ moderate AR
    • Thrombosis
    • Endocarditis
    • Aortic valve re-intervention

Key Secondary Endpoints

  • Mean gradient at 12 months
  • Effective orifice area (EOA) at 12 months
  • HSVD at 12 months
  • BVD in female subjects at 12 months
  • Moderate or severe PPM at 30 days
Photos of EVOLUT products, including Evolut PRO TAV, Evolut PRO+ TAV, SAPIEN 3 TAV, and SAPIEN 3 Ultra TAV.
Photo of doctor checking patient's heartbeat—part of the process to determine eligibility to participate in the SMART trial.

FIND OUT IF YOUR PATIENTS ARE ELIGIBLE

Read through the inclusion/exclusion criteria to help you determine if you have patients who are eligible to participate in the trial.

Additional SMART Trial Information

VIEW TRIAL PAGE

™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.