Post-Dilatation in Balloon-Expandable TAVI Prostheses
ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorMedical University of Vienna
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Post-dilatation
Treatment groups
146 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov