A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm

The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the Sapien 3 valve. The main questions the study aims to answer are: 1. Does the ABC Bicuspid Sizing Algorithm increase the technical success at exit from the procedure room? 2. Does the ABC Bicuspid Sizing Algorithm increase the device success at 30 days after the procedure? Participants already being evaluated for a TAVR as part of their regular medical care for bicuspid aortic stenosis will have their diagnostic images assessed using the ABC Bicuspid Sizing Algorithm to help determine their procedure type and valve size. They will have visits 30 days and annually till 5 years after their procedure.

NCT Number	NCT06991517
Lead Sponsor	World Health Research Inc. Collaborators: Edwards Lifesciences
Conditions	Aortic Stenosis
Enrollment	290 participants
Start Date	2025-05-13
Primary Completion	2026-12 (estimated)
Study Completion	2031-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-21