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Supra-Annular vs. Annular ValvEs for Small Annuli — SAVE  

Aortic Valve Stenosis Clinical Trial

Official title:
Supra-Annular vs. Annular ValvEs for Small Annuli (<= 23mm)

Clinical Trial Summary

Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)

Clinical Trial Description

Patient prothesis mis-match (PPM) remains a clinical dilemma in transcatheter aortic valve replacement (TAVR) and has been linked to higher rates of morbidity and mortality. Supra-annular self-expanding valves have been linked to lower gradients and lower rates of patient prosthesis mismatch versus annular valves but they have not been directly compared. Patients with small annuli are particularly vulnerable to PPM, therefore, the aprior hypothesis is that implantation of supra-annular valves for small annuli may show differences in PPM rates and outcomes when compared to annular valves. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04372381
Study type Interventional
Source University of Arizona
Contact
Status Enrolling by invitation
Phase N/A
Start date May 12, 2020
Completion date June 2025
View Details
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