The SMART Trial.

Not all TAVR is the same.


Evolut™ TAVR delivers superior valve performance‡ in women with small annuli at 1 year vs. SAPIEN™* platform†,1


SMART Trial findings


Exclamation icon Indications, Safety, and Warnings
Woman

Evolut™ TAVR – proven for women.†,1-3


If women do receive TAVR treatment, they have a lower mortality rate compared to SAVR3.  If treated with Evolut TAVR, women with small annulus experience better valve performance‡ compared to the SAPIEN™* platform through 1-year.†,1


Explore the data.

† Based on the 1 year follow-up results from the SMART clinical trial which showed differences in valve performance‡ for Evolut compared to SAPIEN* and no differences in safety outcomes. SMART primarily studied small annulus patients, predominantly women.1 Additional clinical trials on women, regardless of their annulus size, have shown comparable mortality rates in women and men treated with TAVR2 and lower mortality rates for women treated with TAVR compared to women treated with surgical valve replacement3 at 1 year after the procedure.​

‡ Valve performance as defined as freedom from bioprosthetic valve dysfunction (BVD) through 12 months. BVD is defined as a composite including any of the following: hemodynamic structural valve dysfunction (mean gradient ≥ 20 mmHg), non-structural valve dysfunction (severe prothesis-patient mismatch or ≥ moderate aortic regurgitation), clinical thrombosis, endocarditis, and aortic valve reintervention.

¶ In patients with small annuli (area ≤ 430 mm2) in all-comers trial, consisting of majority low surgical risk participants (52.1%).

◊ Bioprosthetic Valve Dysfunction (BVD)4 defined as: SVD (mean gradient ≥10 mmHg increase from 30-day/discharge to last echo AND ≥ 20 mmHg at last echo or new onset/ increase of ≥ moderate intraprosthetic aortic regurgitation), NSVD (severe PPM at 30-day/discharge or severe PVR through 5 years), clinical valve thrombosis, and endocarditis.


  1. Tchétché D, Mehran R, Blackman DJ, et al. Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli: Results From the SMART Randomized Clinical Trial. JAMA Cardiol. Published online October 9, 2024
  2. Forrest, J.K., et al., Transcatheter Aortic Valve Replacement in Women Versus Men (from the US CoreValve Trials). Am J Cardiol, 2016. 118(3): p. 396-402.
  3. Skelding, K.A., et al., Transcatheter Aortic Valve Replacement Versus Surgery in Women at High Risk for Surgical Aortic Valve Replacement (from the CoreValve US High Risk Pivotal Trial). Am J Cardiol, 2016. 118(4): p. 560-6.
  4. Adapted from VARC-3 : Généreux P, Piazza N, Alu MC, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. J Am Coll Cardiol. 2021;77(21):2717–2746.
  5. Yakubov SJ, Van Mieghem NM, Oh JK, et al. Impact of Transcatheter or Surgical Aortic Valve Performance on 5-Year Outcomes in Patients at ≥ Intermediate Risk. J Am Coll Cardiol. April 8, 2025;85(13):1419–1430.
  6. Medtronic data on file based on number needed to treat calculation from SMART Trial 1-year data.7
  7. Herrmann HC, Mehran R, Blackman DJ, et al. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med. June 6 2024;390(21):1959–197.

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

UC202600897 EN 06/2025