Clinical Trial: Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion

U.S., Feb. 25 -- ClinicalTrials.gov registry received information related to the study (NCT07430267) titled 'Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion' on Feb. 04.

Brief 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 TAV...