Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Alfred
About this trial
The goal of this clinical trial is to discover if routine 'double tap' balloon post-dilation improves valve expansion and clinical outcomes in adults undergoing Transcatheter Aortic Valve Implantation (TAVI) with the SAPIEN balloon-expandable TAVI prosthesis.
The primary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve expansion. The secondary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve haemodynamic performance.
Participants will be randomised to balloon-expandable TAVI either with or without routine 'double tap' balloon post-dilation.
Eligibility criteria
Qualifiers
Severe aortic stenosis undergoing trans-femoral TAVI using the SAPIEN 3 Ultra/RESILIA balloon-expandable transcatheter heart valve.
Tricuspid or bicuspid aortic valve stenosis
Disqualifiers
Valve-in-valve TAVI for failure of an existing prosthetic surgical or transcatheter valve failure
TAVI performed for native valve aortic regurgitation
High risk 'hostile' annular anatomy as adjudicated by multidisciplinary Heart Team based on pre-procedure CT anatomy.
Trial design
Treatments tested in this trial
- 'Double tap' balloon post-dilation
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
The Alfred
Lead sponsor
Edwards Lifesciences
Collaborator
Source ClinicalTrials.gov