Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2026
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.
Epistemonikos ID: ba2d04dc06214c9323465a7937a7bd6234c0e39b
First added on: Feb 25, 2026