SMART Trial Patient Eligibility

        

Alert Indications, Safety, and Warnings

Eligibility Criteria

The following outlines inclusion and exclusion criteria for the SMART Trial.

Inclusion Criteria*

  • Heart team agrees that the subject is deemed symptomatic and is a candidate for TAVR, and subject has a predicted risk of operative mortality < 15% at 30 days
  • Subject has severe aortic stenosis as determined by transthoracic echocardiography (TTE) at rest†
  • Subject has a small annulus, ≤ 430 mm2 as determined by multidetector computed tomography (MDCT)
  • Subject’s anatomy is appropriate for both Medtronic Evolut™ PRO/PRO+ TAV and Edwards SAPIEN™* 3/3 Ultra TAV
  • Subject’s anatomy is suitable for TAVR via transfemoral access
  • Subject and treating physician agree that the subject will return for all required post-procedure follow-up visits

Exclusion Criteria*

  • Estimated life expectancy of fewer than two years
  • Multivessel coronary artery disease with a SYNTAX score > 32 and/or unprotected left main coronary artery
  • Participating in another trial that may influence the outcome of this trial
  • Need for an emergent procedure for any reason
  • Contraindicated for treatment with the Evolut PRO/PRO+ and Edwards SAPIEN 3/3 Ultra TAV in accordance with the Instructions for Use
  • Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the subject from appropriate consent or adherence to the protocol required follow-up exams
  • Pregnant, nursing, or planning to be pregnant
  • Subject is less than the legal age of consent, legally incompetent, unable to provide his/her own informed consent, or otherwise vulnerable
  • Subject has an active COVID-19 infection or relevant history of COVID-19
  • Previous aortic valve replacement
*

Additional criteria may apply

†

Severe aortic stenosis defined as: Aortic valve area ≤ 1.0 cm2 (or aortic valve area index of ≤ 0.6 cm2/m2), OR mean gradient ≥ 40 mm Hg, OR maximal aortic valve velocity ≥ 4.0 m/sec by transthoracic echocardiography at rest.

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