Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion

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.

NCT Number	NCT07430267
Lead Sponsor	The Alfred Collaborators: Edwards Lifesciences
Conditions	Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Enrollment	250 participants
Start Date	2026-04-01
Primary Completion	2028-04-01 (estimated)
Study Completion	2029-04-01 (estimated)
Updated on ClinicalTrials.gov	2026-02-24