Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001553864
Ethics application status
Approved
Date submitted
22/09/2021
Date registered
15/11/2021
Date last updated
15/11/2021
Date data sharing statement initially provided
15/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the clinical utility of a calculated Survival Score Index for Implantable Cardioverter Defibrillator (ICD) patients having had device battery replacement or palliative care at an Australian tertiary hospital - SUSCI-AUS study
Scientific title
Assessment of a calculated Survival Score Index (SUSCI) for Implantable Cardioverter Defibrillator (ICD) patients having had device battery replacement or palliative care at an Australian tertiary hospital over a 5 year period through to december 2020.
Secondary ID [1] 304845 0
'Nil known'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart rhythm disorders 323733 0
Cardiac Implanted Electronic Devices 323734 0
Condition category
Condition code
Cardiovascular 321262 321262 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients at Royal Adelaide Hospital who have previously had intervention of their Implantable Cardioverter Defibrillator as either a battery replacement performed, or ellective palliative deactivation of the implant, between 1st January 2015 to 31st December 2020. Clinical parameters will be collected from medical records, and patients will not undergo any additional tests or clinical activities for this study. Differences in clinical parameters will be compared between patient groups and a previously reported Survival Score Index (Zoni-Berisso, et al. 2021 Heart Rhythm) will be utilised for comparison. The group who had ellective palliative deactivation of the implant will be our comparison group to define a cohort who has poor prognosis for life expectancy given palliative care.
Intervention code [1] 321792 0
Diagnosis / Prognosis
Comparator / control treatment
The previously established Survival Score Index was derived from patient who had a battery replacement for their Implantable Cardioverter Defibrillator, so this group will be our control group.
Control group
Active

Outcomes
Primary outcome [1] 329045 0
Comparison of the survival scores, which are calculated individually for each patient from retrospective analysis of existing clinical data, and then combined for grouped analysis according to the intervention of either an Implantable Cardioverter Defibrillator battery replacement, or an elective palliative device deactivation.
Timepoint [1] 329045 0
Assessed from hospital medical records which will be collected up until 5 August 2022 for Implantable Cardioverter Defibrillator patients at Royal Adelaide Hospital who had intervention of either a device battery replacement, or an elective palliative device deactivation between 1st January 2015 to 31st December 2020.
Secondary outcome [1] 401261 0
Comparison of the basic clinical parameters (ie; age, gender, heart failure classification) recorded for each patient obtained from retrospective analysis of existing clinical records, and then combined for grouped analysis according to the intervention of either an Implantable Cardioverter Defibrillator battery replacement, or an elective palliative device deactivation.
Timepoint [1] 401261 0
Assessed from hospital medical records which will be collected up until 5 August 2022 for Implantable Cardioverter Defibrillator patients at Royal Adelaide Hospital who had intervention of either a device battery replacement, or an elective palliative device deactivation between 1st January 2015 to 31st December 2020.

Eligibility
Key inclusion criteria
Implantable Cardioverter Defibrillator insitu which between January 1st 2015 to December 31st 2020 had at the Royal Adelaide Hospital an intervention of battery replacement or elective palliative deactivation performed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac Implantable Electronic Device is does not have Implantable Cardioverter Defibrillator function, or the intervention on the device was performed elsewhere.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Continuous data will be presented as the mean ± SD, or median with interquartile range when appropriate, and compared with 2-tailed Student t tests. Nominal data will be presented as frequencies and percentages and compared by Chi-squared test. Statistical analyses will be performed using SPSS (IBM SPSS Inc, Chicago, IL) and GraphPad Prism (GraphPad Software, Inc, San Diego, CA). A p-value of less than .05 will be used for statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/11/2021
Actual
Date of last participant enrolment
Anticipated
5/08/2022
Actual
Date of last data collection
Anticipated
5/08/2022
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 20571 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 35355 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 309217 0
Self funded/Unfunded
Name [1] 309217 0
Nil
Country [1] 309217 0
Primary sponsor type
Individual
Name
A/Prof Dennis Lau
Address
Centre for Heart Rhythm Disorders, Department of Cardiology, Royal Adelaide Hospital, Port Rd, Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 310179 0
None
Name [1] 310179 0
Nil
Address [1] 310179 0
Nil
Country [1] 310179 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309068 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 309068 0
Royal Adelaide Hospital, Port Rd, Adelaide SA 5000.
Ethics committee country [1] 309068 0
Australia
Date submitted for ethics approval [1] 309068 0
22/06/2021
Approval date [1] 309068 0
05/08/2021
Ethics approval number [1] 309068 0
CALHN Reference Number: 15046

Summary
Brief summary
This study will assessing the clinical utility of a calculated Survival Score Index for Implantable Cardioverter Defibrillator patients having had device battery replacement or palliative care at the Royal Adelaide Hospital. This study will retrospectively assess clinical parameters for patients who meet study inclusion citeria to allow calculation of a score for each individual, which will then be combined for group analysis of patients who had an intervention of battery replacement, or elective palliative deactivation of their device during the 5-year study period up until 31st December 2020.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112858 0
A/Prof Dennis H. Lau
Address 112858 0
Centre for Heart Rhythm Disorders, Cardiology Department, Royal Adelaide Hospital, Port Rd, Adelaide, South Australia, 5000
Country 112858 0
Australia
Phone 112858 0
+61 8 7074 0000
Fax 112858 0
Email 112858 0
[email protected]
Contact person for public queries
Name 112859 0
A/Prof Dennis H. Lau
Address 112859 0
Centre for Heart Rhythm Disorders, Cardiology Department, Royal Adelaide Hospital, Port Rd, Adelaide, South Australia, 5000
Country 112859 0
Australia
Phone 112859 0
+61 8 7074 0000
Fax 112859 0
Email 112859 0
[email protected]
Contact person for scientific queries
Name 112860 0
A/Prof Dennis H. Lau
Address 112860 0
Centre for Heart Rhythm Disorders, Cardiology Department, Royal Adelaide Hospital, Port Rd, Adelaide, South Australia, 5000
Country 112860 0
Australia
Phone 112860 0
+61 8 7074 0000
Fax 112860 0
Email 112860 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not included in approved Ethics application.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.