RecruitingNot ApplicableNCT07477002

Post-Dilatation in Balloon-Expandable TAVI Prostheses

Effects of Post-Dilatation on THV Expansion, Hemodynamics, Durability, and Outcomes in Balloon-Expandable TAVI Prostheses


Sponsor

Medical University of Vienna

Enrollment

146 participants

Start Date

Jan 1, 2025

Study Type

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

Min Age: 65 Years

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

OTHERPost-dilatation

Nominal post-dilatation using the original delivery balloon


Locations(1)

Medical University of Vienna

Vienna, State of Vienna, Austria

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NCT07477002


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