Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion
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- Who runs it
- The Alfred
- Trial code
- NCT07430267
- Record updated
- 24 February 2026
- Original description
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.Read full original descriptionShow less
Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial
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.
Inclusion: 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: Valve-in-valve TAVI for failure of an existing prosthetic surgical or transcatheter valve failure; High risk 'hostile' annular anatomy as adjudicated by multidisciplinary Heart Team based on pre-procedure CT anatomy; TAVI performed for native valve aortic regurgitation.