Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Conditions
Keywords
TAVI, TAVR, Double Tap, balloon post-dilation, Balloon-expandable TAVI
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.
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
Sponsors
The Alfred
Edwards Lifesciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Imaging analysis will be performed by investigators blinded to treatment allocation
Intervention model description
The ACE-DOUBLE trial will be a multicentre, registry nested, block randomized, open label clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopic valve expansion | Day 1 post-procedure | Percentage (%) final valve expansion measured by fluoroscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Haemodynamic performance | Day 1-3 post-procedure | Echocardiographic transvalvular mean pressure gradient (mmHg) |
| Freedom from cardiovascular death or valve reintervention | 1 year and 3 years post-procedure | Freedom from occurrence of composite of cardiovascular death or valve reintervention |
Countries
Australia
Contacts
CONTACTNalin H Dayawansa, MBBS
Outcome results
None listed