The Evolut PRO Study is a prospective, multicenter, non-randomized, single-arm study. Primary safety endpoints were all-cause mortality and disabling stroke at 30 days, and the primary efficacy endpoint was percentage of patients with no or trace aortic regurgitation at 30 days.
- Study Status/Duration: 1-year outcomes reported/
- Sample Size: N = 60
- Devices: Evolut PRO TAV
Patients underwent attempted TAV implant under the same inclusion and exclusion criteria and trial procedures as the SURTAVI Trial, with no randomization to surgery.
- Study Status/Duration: 30-day outcomes reported/5-year follow-up
- Sample Size: N = 275
- Devices: Evolut R 93%/CoreValve 7%, TAV
See the Medtronic TAVI Clinical Evidence Compendium for additional study results.
Williams, as presented in poster at ACC.18
Van Mieghem N, et al. Transcatheter Aortic Valve Replacement with a Self-Expanding Prosthesis or Surgical Aortic Valve Replacement in Intermediate-Risk Patients: 1-Year Results from the SURTAVI Clinical Trial. Presented at TCT 2017.