Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion
Key facts
- Where
- Malvern, Melbourne, and Richmond, AustraliaSee the 3 sites
Where in Australia
- Cabrini HospitalMalvern, AustraliaContact: Shane Nanayakkara, MBBS PHDNo longer taking part
- The Alfred HospitalMelbourne, AustraliaContact: Nalin H Dayawansa, MBBSNo longer taking part
- Epworth HospitalRichmond, AustraliaContact: Stephanie English, RNNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- 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.