Clinical Research Directory
Browse clinical research sites, groups, and studies.
Post-Dilatation in Balloon-Expandable TAVI Prostheses
Sponsor: Medical University of Vienna
Summary
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.
Official title: Effects of Post-Dilatation on THV Expansion, Hemodynamics, Durability, and Outcomes in Balloon-Expandable TAVI Prostheses
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
146
Start Date
2025-01-01
Completion Date
2031-05
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
Post-dilatation
Nominal post-dilatation using the original delivery balloon
Locations (1)
Medical University of Vienna
Vienna, State of Vienna, Austria