Aortic StenosisACE-DOUBLENCT07430267
Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion
A study testing 'Double tap' balloon post-dilation in people with Aortic Stenosis and TAVI(Transcatheter Aortic Valve Implantation), run by The Alfred at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
- What is being tested?
- 'Double tap' balloon post-dilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesAustralia
- Study dates
- 1 Apr 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe aortic stenosis undergoing trans-femoral TAVI using the SAPIEN 3 Ultra/RESILIA balloon-expandable transcatheter heart valve.
- Tricuspid or bicuspid aortic valve stenosis
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites
Cabrini Hospital
Malvern, Victoria, 3144
Shane Nanayakkara, MBBS PHD, +61395081222, S.Nanayakkara@alfred.org.au
The Alfred Hospital
Melbourne, Victoria, 3004
Nalin H Dayawansa, MBBS, +61390765784, na.dayawansa@alfred.org.au
Epworth Hospital
Richmond, Victoria, 3121
Stephanie English, RN, +61 3 9426 6693, stephanie@tonywalton.com.au
About this study
Official title: Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial
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.
Read the 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)
- Being tested
- 'Double tap' balloon post-dilation
- Keywords
- TAVI, TAVR, Double Tap, balloon post-dilation, Balloon-expandable TAVI
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Double tap' balloon post-dilationOther
Routine second inflation of the valve delivery balloon ('double-tap') BPD following balloon-expandable valve TAVI
| Study group | Role | What they receive |
|---|---|---|
| Routine deployment | No intervention | Participants in the routine deployment arm will have no further post-dilation after satisfactory initial deployment of the balloon-expandable THV |
| Routine double tap | Experimental | 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 Receives: Other: 'Double tap' balloon post-dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluoroscopic valve expansion
Percentage (%) final valve expansion measured by fluoroscopy
Measured: Day 1 post-procedure
Secondary outcomes (3)
Haemodynamic performance
Echocardiographic transvalvular mean pressure gradient (mmHg)
Measured: Day 1-3 post-procedure
Haemodynamic performance
Echocardiographic aortic valve area (cmsq)
Measured: Day 1-3 post-procedure
Freedom from cardiovascular death or valve reintervention
Freedom from occurrence of composite of cardiovascular death or valve reintervention
Measured: 1 year and 3 years post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The ACE-DOUBLE trial will be a multicentre, registry nested, block randomized, open label clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Nalin Dayawansa, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430267
- Sponsor's protocol ID
- 058-26
- Acronym
- ACE-DOUBLE
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data cannot be released without specific approval from the HREC committee.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial
- ClinicalTrials.gov ID
- NCT07430267
- Acronym / sponsor ID
- ACE-DOUBLE / 058-26
- Keywords
- TAVI, TAVR, Double Tap, balloon post-dilation, Balloon-expandable TAVI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The ACE-DOUBLE trial will be a multicentre, registry nested, block randomized, open label clinical trial
| Arm | Type | Receives |
|---|---|---|
| Routine deployment | No intervention | –Participants in the routine deployment arm will have no further post-dilation after satisfactory initial deployment of the balloon-expandable THV |
| Routine double tap | Experimental | Other: 'Double tap' balloon post-dilationParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Severe aortic stenosis undergoing trans-femoral TAVI using the SAPIEN 3 Ultra/RESILIA balloon-expandable transcatheter heart valve.
- Tricuspid or bicuspid aortic valve stenosis
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'Double tap' balloon post-dilationRoutine second inflation of the valve delivery balloon ('double-tap') BPD following balloon-expandable valve TAVI | Other | Routine double tap |
Primary outcome
Fluoroscopic valve expansion
Time frame: Day 1 post-procedure
Percentage (%) final valve expansion measured by fluoroscopy
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data cannot be released without specific approval from the HREC committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Double tap' balloon post-dilation in people with Aortic Stenosis and TAVI(Transcatheter Aortic Valve Implantation), run by The Alfred at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nalin H Dayawansa, MBBS (+61390765784, na.dayawansa@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluoroscopic valve expansion (time frame: Day 1 post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.