The study aims to find out whether using the ABC Bicuspid Sizing Algorithm helps doctors choose the best treatment approach and valve size for people with bicuspid aortic stenosis, leading to safer and more successful transcatheter aortic valve replacement (TAVR) procedures.
Research Objectives
Status
Recruitment
Total participants required
Study location
Study type
Patient group
About this clinical trial
Patients with narrowing of the aortic valve require careful assessment to determine the safest and most effective treatment approach. Heart teams currently use several methods to decide whether a patient should undergo transcatheter or surgical valve replacement, with CT scans playing a central role in understanding each patient’s heart structure. The ABC Bicuspid Sizing Algorithm is a new tool developed specifically for patients receiving the Sapien 3 valve. It expands on existing sizing methods by guiding teams to take more detailed measurements, allowing for a more personalised approach to selecting the procedure type and valve size. This algorithm is designed to complement and standardise current practice, ensuring decisions are consistent and based on comprehensive anatomical assessment. Early results from a single‑centre study have been highly encouraging, and this trial will evaluate how well the algorithm works across multiple hospitals and countries, including its impact on outcomes after TAVI using the Sapien 3 valve.
For the above, prospective, multi‑centre cohort study https://clinicaltrials.gov/study/NCT06991517
Lead investigator
- Dr Karl Poon
Clinical trial coordinator
- Linda Pearce
Technical title
A Prospective Cohort Study of Bicuspid Case Selection and Valve Sizing using the ABC Bicuspid Sizing Algorithm for Sapien 3 Balloon Expandable Valve
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