Supra-Annular vs. Annular ValvEs for Small Annuli
Megadott ok: No participants enrolled at University of Arizona site.
A legfontosabb adatok
- Hol
- Delray Beach, Phoenix és Tucson (Egyesült Államok)Mind a 3 helyszín megnézése
Helyszínek itt: Egyesült Államok
- Delray Medical CenterDelray Beach, Egyesült ÁllamokNo longer taking part
- Banner - University Medical Center, Phoenix campusPhoenix, Egyesült ÁllamokNo longer taking part
- Tucson Medical CenterTucson, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- University of Arizona
- Azonosító
- NCT04372381
- A regiszteradat frissítve
- 2026. július 24.
- Eredeti leírás
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)A teljes eredeti leírásKevesebb
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)
Bevonási feltételek: 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.
Kizáró feltételek: 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.