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Trial registered on ANZCTR


Registration number
ACTRN12613000083796
Ethics application status
Approved
Date submitted
18/01/2013
Date registered
22/01/2013
Date last updated
18/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Silent and Apparent Neurological Injury in Transcatheter Aortic Valve Implantation (TAVI)
Scientific title
In patients with severe Aortic Stenosis undergoing Transcatheter Aortic Valve Implantation (TAVI), what associated neurological injury exists as measured radiologically (magnetic resonance imaging), serological markers of neurological injury (s100B and GFAP) and clinically (neurological assessment, neurocognitive assessment, health-related quality of life scales).
Secondary ID [1] 281799 0
Nil
Universal Trial Number (UTN)
U1111-1137-1339
Trial acronym
The SANITY Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transcatheter Aortic Valve Implantation (TAVI) 288125 0
Neurological Injury 288126 0
Condition category
Condition code
Cardiovascular 288502 288502 0 0
Other cardiovascular diseases
Surgery 288503 288503 0 0
Other surgery
Stroke 288504 288504 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. Diffusion-weighted magnetic resonance imaging (DW-MRI) prior to, 4 (+/-2) days and 6 months following TAVI.
2. Continuous cerebral oximetry monitoring with near infra-red spectroscopy (NIRS) following induction of anaesthesia through to completion of TAVI.
3. Serological tests (s100B, NSE, Urea, Creatinine, LFTs, BNP) prior to and following procedure (time intervals based on characteristic serum 'wash-out' curves.
4. Objective neurocognitive assessment prior to and 3 days, 6 weeks and 6 months following the procedure.
5. Structured neurological examination prior to and 3 days, 6 weeks and 6 months following the procedure.
6. Computed tomography scanning of the chest to facilitate calcification scoring of aorta, aortic arch and valve.
7. Carotid Duplex ultrasonography pre-procedure to assess pre-existing carotid disease.

This is an observational study of all patients selected as eligible candidates for the TAVI procedure (at the discretion of the treating "Heart Team" and the patient). Usually the procedure is reserved for patients with severe Aortic Stenosis who are deemed too high-risk for traditional surgical aortic valve surgery. More recently, TAVI use has extended into intermediate risk populations who are otherwise suitable for surgical aortic valve replacement. The TAVI procedure is considered lower risk as the replacement aortic valve is delivered in a less invasive way than in traditional aortic valve surgery and generally does not require the heart-lung machine (cardiopulmonary bypass). Access to the heart is via the blood vessels through wires and catheters delivered either through the groin or through a small incision in the chest wall. Once appropriately positioned the TAVI prosthesis is deployed and assumes the function of the native aortic valve. The duration of this procedure varies according to approach, however generally is between 30 to 90 minutes. Anaesthetic is required and may be either complete general anesthesia or conscious sedation.
Intervention code [1] 286344 0
Not applicable
Comparator / control treatment
Risk-matched patients undergoing Aortic Valve Replacement (AVR).
Control group
Active

Outcomes
Primary outcome [1] 288659 0
New cerebral infarction on DW-MRI following index procedure
Timepoint [1] 288659 0
MRI - Day 4 +/- 2 days
MRI - 6 months
Secondary outcome [1] 300719 0
Cerebrovascular Event as per Valve Academic Research Consortium 2nd revision (VARC-2) criteria including: major stroke; minor stroke; transient ischaemic attack
Timepoint [1] 300719 0
30 days
Secondary outcome [2] 300720 0
Mortality according to VARC-2 criteria, including: all-cause mortality and cardiovascular associated mortality.
Timepoint [2] 300720 0
30 days and 6 months
Secondary outcome [3] 300721 0
Post-operative cognitive dysfunction - measured as change in MOCA score of greater than 20 % from baseline. Additionally, a cut off score of 24/30 will be used to define cognitive impairment.
Timepoint [3] 300721 0
The MoCA will be assessed at baseline (<48 hours prior to procedure), and 3 days, 6 weeks and 6 months post procedure.
Secondary outcome [4] 322979 0
Post operative delirium - measured as a change in CAM
Timepoint [4] 322979 0
The CAM is assessed at baseline (<48 hours prior to procedure), and daily for the duration of inpatient stay, at 6 weeks and 6 months post procedure.

Eligibility
Key inclusion criteria
All consenting patients undergoing transcatheter aortic valve implantation (TAVI) via the transfemoral, transaortic and transapical routes with the Edwards SAPIEN-XT valve under general anaesthetic.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Lacks capacity to consent for him or herself.
2. Pre-existing neurological impairment measured as modified Rankin Score >=3.
3. Contraindication to MRI (including incompatible metallic prosthesis/foreign body, inability to lie flat, claustrophobia requiring sedation)
4. Non or poor English-speaking due to nature of cognitive testing and unknown validity in such populations
5. Previous aortic valve repair/replacement.
6. Coronary artery disease requiring revascularisation (including patients undergoing combined AVR and CABG).

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
An estimated 80-120 patients will be recruited into this study, At least 20 patients in to each of the treatment groups (SAVR, transfemoral TAVI, transaortic TAVI and transapical TAVI). 20 patients per group provides 90% power to detect differences in the incidence of new DWI lesions (primary endpoint) with two-sided statistical significance of 5%, assuming overall incidence estimates of 76% and 45% with TAVI and SAVR, respectively, as previously reported. Multiple regression models will be used to adjust for potential confounders identified based upon clinical importance and statistical selection. The key output will be the estimated difference and 95% confidence intervals for the primary group from the multiple regression models. Additionally, longitudinal analysis will be used to examine all outcomes with repeated data, again using multiple regression models. Treatment failure and withdrawal will be considered on an intention-to-treat basis, with the aim of providing a more realistic estimate of the difference between groups in clinical practice.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/01/2014
Actual
30/01/2014
Date of last participant enrolment
Anticipated
31/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 434 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 435 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 6199 0
4032 - Chermside
Recruitment postcode(s) [2] 6200 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 286583 0
Charities/Societies/Foundations
Name [1] 286583 0
The Prince Charles Hospital Foundation (TPCHF)
Country [1] 286583 0
Australia
Funding source category [2] 286584 0
University
Name [2] 286584 0
The University of Queensland (UQ)
Country [2] 286584 0
Australia
Primary sponsor type
University
Name
Critical Care Research Group (CCRG)
Address
Adult Intensive Care Services (AICS),
Level 2 Emergency Building,
The Prince Charles Hospital,
Rode Road,
Chermside, 4032
Brisbane, Queensland
Country
Australia
Secondary sponsor category [1] 285367 0
Other Collaborative groups
Name [1] 285367 0
The Baird Institute
Address [1] 285367 0
PO Box M85
Camperdown, 2050
NSW
Country [1] 285367 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288659 0
The Prince Charles Hospital HREC
Ethics committee address [1] 288659 0
Ethics committee country [1] 288659 0
Australia
Date submitted for ethics approval [1] 288659 0
20/11/2012
Approval date [1] 288659 0
19/12/2012
Ethics approval number [1] 288659 0
HREC/12/QPCH/291

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37154 0
Dr Jonathon Fanning
Address 37154 0
Critical Care Research Group (CCRG)
Adult Intensive Care Services
Level 2 Emergency Building
The Prince Charles Hospital
Rode Road
Chermside, 4032
Brisbane, Queensland
Country 37154 0
Australia
Phone 37154 0
+61410408777
Fax 37154 0
Email 37154 0
jonathon_fanning@me.com
Contact person for public queries
Name 37155 0
Jonathon Fanning
Address 37155 0
Critical Care Research Group (CCRG)
Adult Intensive Care Services
Level 2 Emergency Building
The Prince Charles Hospital
Rode Road
Chermside, 4032
Brisbane, Queensland
Country 37155 0
Australia
Phone 37155 0
+61410408777
Fax 37155 0
Email 37155 0
jonathon_fanning@me.com
Contact person for scientific queries
Name 37156 0
Jonathon Fanning
Address 37156 0
Critical Care Research Group (CCRG)
Adult Intensive Care Services
Level 2 Emergency Building
The Prince Charles Hospital
Rode Road
Chermside, 4032
Brisbane, Queensland
Country 37156 0
Australia
Phone 37156 0
+61410408777
Fax 37156 0
Email 37156 0
jonathon_fanning@me.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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