Study of Using the ABC Bicuspid Sizing Algorithm to Guide Valve Selection and Treatment in Bicuspid Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Replacement with Sapien 3 Valve

What this Trial Is About

Researchers are evaluating the effects of the ABC Bicuspid Sizing Algorithm on patients with bicuspid aortic stenosis undergoing transcatheter aortic valve replacement TAVR using the Sapien 3 valve. This international, multi-center study aims to determine if the algorithm improves technical success immediately after the procedure and device success 30 days later. The study also examines how additional imaging techniques like gated computed tomography and artificial intelligence-based simulations influence treatment decisions. The study involves about 290 patients eligible for TAVR or surgical aortic valve replacement SAVR. Physicians use the ABC Bicuspid Sizing Algorithm to guide treatment allocation between TAVR and SAVR, as well as valve sizing and deployment for those receiving TAVR. Some patients may have further evaluation with gated CT or AI simulations to assess risks. Data for TAVR patients is collected at baseline, during the procedure, at hospital discharge, 30 days after, and annually up to 5 years. SAVR patients have data collected at baseline and during the procedure only. Participants will undergo diagnostic imaging including CT scans evaluated with the sizing algorithm and may receive additional assessments if indicated. Researchers collect data on procedure success, device outcomes, conduction disturbances, pacemaker implants, stroke, vascular complications, mortality, valve function, and hospitalizations for heart failure over 5 years. Follow-up visits occur at 30 days and annually, allowing long-term monitoring of outcomes after treatment.

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