Clinical Research Directory

Post-Dilatation Effect on TAVI Prostheses Expansion

Sponsor: Medical University of Vienna

Summary

Asymmetrical and inadequate expansion of trans-catheter heart valves (THVs) have been described as a key predictor of impaired valve hemodynamic performance predisposing patients for bio-prosthetic 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 DUO-TAP trial aims to assess efficacy and safety of routine post-dilatation on THV expansion, asymmetry, hemodynamic, durability, and associated clinical outcomes in patients with severe aortic stenosis.

Official title: Effects of Post-Dilatation on Valve Hemodynamics, Durability and Outcome in Balloon-Expandable TAVI Prostheses (The Randomized-Controlled DUOTAP Trial).

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