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RECRUITING
NCT07477002
NA

Post-Dilatation in Balloon-Expandable TAVI Prostheses

Sponsor: Medical University of Vienna

View on ClinicalTrials.gov

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

Interventions

OTHER

Post-dilatation

Nominal post-dilatation using the original delivery balloon

Locations (1)

Medical University of Vienna

Vienna, State of Vienna, Austria