Medtronic SMall Annuli Randomized To Evolut or Sapien Trial (SMART Trial)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Aortic Stenosis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Symptomatic subjects with predicted risk of operative mortality < 15% at 30-days per multidisciplinary local heart team assessment
    2. Severe aortic stenosis
    3. Aortic valve annulus area = 430 mm2 based on Multi- detector computed tomography (MDCT)
    4. Subject's anatomy is appropriate for both Medtronic Evolut PRO/PRO+ TAV and Edwards SAPIEN 3/3 Ultra TAV
    5. Subject's anatomy is suitable for TAVR via transfemoral vessel access
    6. Commercial indication for transcatheter aortic valve replacement (TAVR), in conformity with both local regulations and Instructions for Use (IFU)
    7. Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits

You may not be eligible for this study if the following are true:

    1. Estimated life expectancy of less than 2 years
    2. Multivessel coronary artery disease with a Syntax score >32 and/or unprotected left main coronary artery
    3. Participating in another trial that may influence the outcome of this trial
    4. Need for an emergent procedure for any reason
    5. Contraindicated for treatment with the Evolut PRO/PRO+ and Edwards SAPIEN 3/3 Ultra TAV in accordance with the Instructions for Use
    6. 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
    7. Pregnant, nursing or planning to be pregnant
    8. Subject is less than legal age of consent, legally incompetent, unable to provide his/her own informed consent, or otherwise vulnerable
    9. Subject has an active COVID-19 infection or relevant history of COVID-19
    10. Previous aortic valve replacement



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