Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial (NCT07430267)

The goal of this clinical trial is to discover if routine 'double tap' balloon post-dilation improves valve expansion and clinical outcomes in adults undergoing Transcatheter Aortic Valve Implantation (TAVI) with the SAPIEN balloon-expandable TAVI prosthesis. The primary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve expansion. The secondary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve haemodynamic performance. Participants will be randomised to balloon-expandable TAVI either with or without routine 'double tap' balloon post-dilation.

Trial phase

Other

Trial participation type

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

Principal investigator

Dr Shane Nanayakkara

Key inclusion data

Inclusion Criteria: Severe aortic stenosis undergoing trans-femoral TAVI using the SAPIEN 3 Ultra/RESILIA balloon-expandable transcatheter heart valve. Tricuspid or bicuspid aortic valve stenosis Exclusion Criteria: Valve-in-valve TAVI for failure of an existing prosthetic surgical or transcatheter valve failure TAVI performed for native valve aortic regurgitation High risk 'hostile' annular anatomy as adjudicated by multidisciplinary Heart Team based on pre-procedure CT anatomy.