Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:36 AM
Study NCT ID:
NCT07430267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion
Sponsor:
The Alfred
Organization:
Study Overview
Official Title:
Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACE-DOUBLE
Brief 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.
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)
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)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: