NCT06991517

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

A Prospective Cohort Study of Bicuspid Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm for Sapien 3 Balloon Expandable Valve

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 290 (estimated)
• Sponsor: World Health Research Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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 one year after their procedure.

Detailed description

This is a multi-centre, international, prospective cohort study. Approximately 290 patients who are clinically eligible for transcatheter aortic valve replacement (TAVR) will be enrolled. Using information collected with the ABC Bicuspid Sizing Algorithm, physicians will make a treatment allocation between TAVR and surgical aortic valve replacement (SAVR), and determine valve sizing and deployment for TAVR-treated patients. Included in the algorithm use is the utilization of gated computed tomography evaluation or artificial intelligence-based simulation models in select cases with borderline feasibility. The findings of these additional assessments will be shared with the treating physicians for consideration in the final treatment decision. Of the 290 patients, an estimated 230 will be recommended to have TAVR. Data will be collected from TAVR-treated patients at baseline, procedure, hospital discharge, and 30 days and one year after the procedure. Data will only be collected from SAVR-treated patients at baseline and procedure. Sites in Canada, Latin America, the Middle East, and Asia Pacific will participate.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
OTHER	The ABC Bicuspid Sizing Algorithm	The ABC Bicuspid Sizing Algorithm is a valve sizing algorithm. It guides operators' evaluations of CT scans, helping inform (1) treatment allocation between TAVR and surgical aortic valve replacement, and (2) valve choice for patients undergoing TAVR. In select cases, the algorithm will suggest gated CT evaluation or artificial intelligence-based simulation models be used to further evaluate the risk of the planned valve size and deployment volume. The operators will consider the findings of the ABC Bicuspid Sizing Algorithm as well as other clinical factors when making their final treatment decisions.

Timeline

• Start date: 2025-05-13
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-05-28
• Last updated: 2025-11-28

Locations

21 sites across 8 countries: Australia, Canada, Colombia, Costa Rica, Mexico, New Zealand, Singapore, Thailand