Supra-Annular vs. Annular ValvEs for Small Annuli
Reason given: No participants enrolled at University of Arizona site.
Key facts
- Where
- Delray Beach, Phoenix, and Tucson, United StatesSee the 3 sites
Where in United States
- Delray Medical CenterDelray Beach, United StatesNo longer taking part
- Banner - University Medical Center, Phoenix campusPhoenix, United StatesNo longer taking part
- Tucson Medical CenterTucson, United StatesNo longer taking part
Trial details
- Who runs it
- University of Arizona
- Trial code
- NCT04372381
- Record updated
- 24 July 2026
- Original description
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)Read full original descriptionShow less
Supra-Annular vs. Annular ValvEs for Small Annuli (<= 23mm)
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
Inclusion: Symptomatic subjects with severe native aortic valve stenosis; aortic valve annulus mean diameter ≤23 mm; Patient meet commercial indication for transcatheter aortic valve replacement (TAVR); Institutional heart team determines that TAVR is appropriate; Patient's anatomy is appropriate for either Medtronic Evolute or Edwards Sapien 3 Ultra.
Exclusion: Intended concurrent structural heart procedure (e.g. transcatheter mitral valve repair or replacement, left atrial appendage closure); Pregnancy or intent on becoming pregnant prior to completion of all proctocol follow-up procedures; Renal function precluding the administration of iodinated contrast (eGFR < 30ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media; Subject unable or unwilling to provide informed consent; Patients at high risk for coronary obstruction; Patients with low-flow low gradient aortic valve stenosis; patients at high risk for annular rupture with implantation of a balloon expandable valve.