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Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion
Sponsor: The Alfred
Summary
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.
Official title: Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2026-04-01
Completion Date
2029-04-01
Last Updated
2026-02-24
Healthy Volunteers
No
Interventions
'Double tap' balloon post-dilation
Routine second inflation of the valve delivery balloon ('double-tap') BPD following balloon-expandable valve TAVI
Locations (3)
Cabrini Hospital
Malvern, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Epworth Hospital
Richmond, Victoria, Australia