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

Launched by WORLD HEALTH RESEARCH INC. · May 26, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new method called the ABC Bicuspid Sizing Algorithm to see how it can improve outcomes for patients with a specific heart condition known as bicuspid aortic stenosis. This condition occurs when the aortic valve in the heart does not open properly, which can lead to serious health issues. The study will look at whether using this sizing algorithm helps doctors successfully place a new heart valve called the Sapien 3 during a procedure known as transcatheter aortic valve replacement (TAVR). Researchers will also check if this method leads to better results for patients 30 days after the procedure.

To be eligible for this trial, participants must have bicuspid aortic valve disease and severe aortic stenosis that requires treatment, but they should not have other conditions needing surgical intervention. They also need to have had a specific type of heart scan and must be suitable for the Sapien 3 valve. Participants will have their diagnostic images reviewed to determine the best approach for their valve replacement and will return for follow-up visits 30 days and one year after their procedure. This study is currently recruiting patients, and it aims to enhance how heart valve replacements are done, potentially leading to better care for individuals with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have bicuspid aortic valve disease
• • Have severe aortic stenosis or mixed aortic stenosis and regurgitation requiring treatment
• • Have no other condition requiring surgical intervention
• • Have had a TAVR CT scan (retrospectively gated contrast enhanced acquisition) that is of diagnostic quality and includes multiphase reconstructions of the aortic root at the minimum available slice thickness (with at least three systolic and one diastolic phases)
• • Would be treated with a Sapien 3 valve if found to be anatomically suitable for TAVR
• • Have a suitable access route for TAVR with a Sapien 3 valve
• Exclusion Criteria:
• • Are treated with TAVR using a device other than a Sapien 3 valve
• • Are unable to be treated with TAVR due to intercurrent illness, clinical instability, or death on waitlist after being accepted for TAVR