Post-Dilatation in Balloon-Expandable TAVI Prostheses

Asymmetrical and inadequate expansion of transcatheter heart valves (THVs) have been described as a key predictor of impaired valve hemodynamic performance predisposing patients for bioprosthetic valve dysfunction (BVD) and death. Post-dilatation using the original delivery system balloon at the identical filling volume after deployment of balloon-expandable THVs represents an invasive strategy to potentially optimize expansion and reduce asymmetry of balloon-expandable THVs. Currently, the efficacy and safety of routine post-dilatation has never been assessed in a randomized controlled fashion. The present randomized controlled DUOTAP trial aims to assess efficacy and safety of routine post-dilatation on THV expansion, hemodynamics, durability, and associated clinical outcomes in patients with severe aortic stenosis.

NCT Number	NCT07477002
Lead Sponsor	Medical University of Vienna
Conditions	Aortic Valve Stenosis
Enrollment	146 participants
Start Date	2025-01-01
Primary Completion	2026-04-23 (estimated)
Study Completion	2031-04 (estimated)
Updated on ClinicalTrials.gov	2026-07-10