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

To evaluate the clinical outcomes of patients with bicuspid aortic stenosis treated with TAVI using the Sapien 3 valve based on the ABC sizing app

Trial phase

Other

Trial participation type

This trial is for clinical research of something other than a drug or device.

Principal investigator

Prof Antony Walton

Key inclusion data

Inclusion Criteria: Have severe AS requiring treatment; Have no other condition requiring surgical intervention; Have an adequate CT TAVI with at least 3 systolic phases and 1 diastolic phase; Would be treated with the Sapiens 3 valve; Have a suitable access route for TAVI with a Sapiens 3 valve. Exclusion Criteria: Treated with valve other than Sapien 3 valves; Are unable to be treated with TAVI due to intercurrent illness, clinical instability or death whilst on wait list.