Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion

NCT07430267 · tracked via the Priya Life Science Australia tracker

Sponsor

The Alfred

Phase

Not applicable

Started

2026-04-01

Last updated

2026-02-24

Condition(s) studied

Aortic StenosisTAVI(Transcatheter Aortic Valve Implantation)

Investigational drug(s) / intervention(s)

'Double tap' balloon post-dilation

'Double tap' balloon post-dilation: Routine second inflation of the valve delivery balloon ('double-tap') BPD following balloon-expandable valve TAVI

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Fluoroscopic valve expansion — Day 1 post-procedure
Percentage (%) final valve expansion measured by fluoroscopy

Trial sites (3)

Facility	City	Region
Cabrini Hospital	Malvern	Victoria
The Alfred Hospital	Melbourne	Victoria
Epworth Hospital	Richmond	Victoria

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07430267 on ClinicalTrials.gov ↗ ← All trials in Australia