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Clinical Trial NCT07430267 (ACE-DOUBLE) for Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion (ACE-DOUBLE) 250
Clinical Trial NCT07430267 (ACE-DOUBLE) is an interventional study for Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation) and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 250 participants. Led by The Alfred, this study is expected to complete by 1 April 2029. The latest data from ClinicalTrials.gov was last updated on 24 February 2026.
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' ...
Show MoreDetailed 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 ...
Show MoreOfficial Title
Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial
Conditions
Aortic StenosisTAVI(Transcatheter Aortic Valve Implantation)Other Study IDs
- ACE-DOUBLE
- 058-26
NCT ID Number
Start Date (Actual)
2026-04-01
Last Update Posted
2026-02-24
Completion Date (Estimated)
2029-04-01
Enrollment (Estimated)
250
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
TAVI
TAVR
Double Tap
balloon post-dilation
Balloon-expandable TAVI
TAVR
Double Tap
balloon post-dilation
Balloon-expandable TAVI
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No InterventionRoutine deployment Participants in the routine deployment arm will have no further post-dilation after satisfactory initial deployment of the balloon-expandable THV | N/A |
ExperimentalRoutine double tap Participants in the double tap arm will undergo a second inflation of the delivery system balloon at the same filll volume after satisfactory initial deployment of the balloon-expandable THV | 'Double tap' balloon post-dilation Routine second inflation of the valve delivery balloon ('double-tap') BPD following balloon-expandable valve TAVI |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Fluoroscopic valve expansion | Percentage (%) final valve expansion measured by fluoroscopy | Day 1 post-procedure |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Haemodynamic performance | Echocardiographic transvalvular mean pressure gradient (mmHg) | Day 1-3 post-procedure |
Haemodynamic performance | Echocardiographic aortic valve area (cmsq) | Day 1-3 post-procedure |
Freedom from cardiovascular death or valve reintervention | Freedom from occurrence of composite of cardiovascular death or valve reintervention | 1 year and 3 years post-procedure |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Severe aortic stenosis undergoing trans-femoral TAVI using the SAPIEN 3 Ultra/RESILIA balloon-expandable transcatheter heart valve.
- Tricuspid or bicuspid aortic valve stenosis
- 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.
The AlfredEdwards LifesciencesStudy Responsible Party
Nalin Dayawansa, Principal Investigator, Associate Investigator, The Alfred
Study Central Contact
Contact: Nalin H Dayawansa, MBBS, +61390765784, [email protected]
3 Study Locations in 1 Countries
Victoria
Cabrini Hospital, Malvern, Victoria, 3144, Australia
Shane Nanayakkara, MBBS PHD, Contact, +61395081222, [email protected]
The Alfred Hospital, Melbourne, Victoria, 3004, Australia
Nalin H Dayawansa, MBBS, Contact, +61390765784, [email protected]
Epworth Hospital, Richmond, Victoria, 3121, Australia
Stephanie English, RN, Contact, +61 3 9426 6693, [email protected]