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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
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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 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 'Double tap' balloon post-dilation | Other | Routine second inflation of the valve delivery balloon ('double-tap') BPD following balloon-expandable valve TAVI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fluoroscopic valve expansion | Percentage (%) final valve expansion measured by fluoroscopy | Day 1 post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Haemodynamic performance | Echocardiographic transvalvular mean pressure gradient (mmHg) | Day 1-3 post-procedure |
| Haemodynamic performance | Echocardiographic aortic valve area (cmsq) |
| Measure | Description | Time Frame |
|---|---|---|
| CT sub-study: final valve expansion measured by non-contrast computed tomography | CT sub-study: final valve expansion (%) measured by non-contrast computed tomography | 30-90 days post-procedure |
| New permanent pacemaker implantation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nalin H Dayawansa, MBBS | Contact | +61390765784 | na.dayawansa@alfred.org.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabrini Hospital | Malvern | Victoria | 3144 | Australia |
Individual participant data cannot be released without specific approval from the HREC committee.
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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The ACE-DOUBLE trial will be a multicentre, registry nested, block randomized, open label clinical trial
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Imaging analysis will be performed by investigators blinded to treatment allocation
| 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 |
New permanent pacemaker implantation
| 30 days post-procedure |
| Stroke | Confirmed stroke | 30 days post-procedure |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
|
| Epworth Hospital | Richmond | Victoria | 3121 | Australia |
|
| D014694 |
| Ventricular Outflow Obstruction |