Post-Dilatation in Balloon-Expandable TAVI Prostheses
Effects of Post-Dilatation on THV Expansion, Hemodynamics, Durability, and Outcomes in Balloon-Expandable TAVI Prostheses
Medical University of Vienna
146 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Severe AS
- AS treatment by transfemoral TAVI as determined by an interdisciplinary heart team board
- Anatomical feasibility to receive a balloon-expandable THV
- Age 65 years or older
- Informed consent
Exclusion Criteria5
- Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., non compliant, perforated)
- Bicuspid aortic valve anatomy
- Valve-in-valve procedure
- Severe calcification of the aortic annulus protruding into the left ventricular outflow tract and predisposing for annular rupture
- Significant stenosis of the left main or proximal left anterior descending artery with substantial risk of hemodynamic instability during rapid ventricular pacing
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Interventions
Nominal post-dilatation using the original delivery balloon
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07477002