Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion

Starting soon · Not applicable

Conditions studied: Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)

In brief

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.

Key facts

Study ID

NCT07430267

Run by

The Alfred

People needed

250

Starts

2026-04-01

Expected to finish

2029-04-01

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Severe aortic stenosis undergoing trans-femoral TAVI using the SAPIEN 3 Ultra/RESILIA balloon-expandable transcatheter heart valve.
• Tricuspid or bicuspid aortic valve stenosis

You may not qualify if…

• 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.

Where it is running

• Cabrini Hospital — Malvern, Victoria, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Epworth Hospital — Richmond, Victoria, Australia

Full record on ClinicalTrials.gov

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