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Not yet recruiting NCT07430267

Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion

No phase Interventional Aortic Stenosis TAVI(Transcatheter Aortic Valve Implantation)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 'Double tap' balloon post-dilation.
Who it may be relevant to
Registry conditions: Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial

Overview

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.

Detailed description

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)

Interventions

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

Primary outcome measures

  • Fluoroscopic valve expansion [Time frame: Day 1 post-procedure]
Secondary outcome measures (3)
  • Haemodynamic performance [Time frame: Day 1-3 post-procedure]
  • Haemodynamic performance [Time frame: Day 1-3 post-procedure]
  • Freedom from cardiovascular death or valve reintervention [Time frame: 1 year and 3 years post-procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Australia · 3 centers
  • Cabrini Hospital — Malvern
  • The Alfred Hospital — Melbourne
  • Epworth Hospital — Richmond

Identifiers

NCT: NCT07430267 · 058-26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗