Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion

The ACE-DOUBLE trial will be a multicentre, registry nested, block randomized, open label clinical trial comparing routine versus discretionary balloon post-dilation strategies following TAVI using the SAPIEN 3 balloon-expandable THV for severe aortic stenosis (AS).

Patients with severe symptomatic aortic valve disease that are accepted for TAVI using a balloon-expandable THV. Currently, the only balloon-expandable THV in routine clinical practice in Australia are the Sapien 3 Ultra and Sapien 3 Ultra Resilia (Edwards Lifesciences, Irvine CA, USA). Patients will be recruited from three TAVI centres participating in the ACE registry: The Alfred Hospital, Cabrini Hospital and Epworth Hospital are all located in Melbourne, Australia.

Specific sub-groups may benefit more from balloon post-dilation (BPD), and hence exploratory analyses will be performed to examine the effect of BPD on primary endpoints in the following subgroups:

• Male vs Female
• Pre-dilation vs no pre-dilation
• Tricuspid vs bicuspid aortic valve
• Very severe AS (mean pressure gradient > 50mmHg)
• Very aortic valve high calcium score (>3000 in males, >1900 in females)

Inclusion criteria

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

Exclusion criteria

• 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.