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Trial registered on ANZCTR


Registration number
ACTRN12620001232921
Ethics application status
Approved
Date submitted
21/07/2020
Date registered
17/11/2020
Date last updated
30/06/2021
Date data sharing statement initially provided
17/11/2020
Date results information initially provided
30/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Anticoagulation Rates in Patients with Atrial Fibrillation Detected via Remote Monitoring
Scientific title
Device-Detected Atrial Fibrillation in a Large Remote-Monitored Cohort: An Observational Study of Implications for Anticoagulation in Patients with a Cardiac Implantable Electronic Device
Secondary ID [1] 301831 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 318313 0
Stroke 318314 0
Cardiac implantable electronic device 318315 0
Condition category
Condition code
Cardiovascular 316324 316324 0 0
Other cardiovascular diseases
Stroke 316852 316852 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
We aim to assess the burden of atrial fibrillation (AF) episodes in patients with a cardiac implantable electronic device in situ, including permanent pacemakers (PPMs), implantable cardioverter defibrillators (ICDs), and implantable loop recorders (ILRs). Further, we aim to correlate the duration of AF episodes with rates of anticoagulation (for the purpose of stroke prevention) in patients deemed to be at significant risk of ischaemic stroke in the setting of AF.

All patients with a PPM, ICD, or ILR in situ who were connected to the PaceMate remote monitoring service, and transmitted at least one AF episode during the 12-month study period, will be included. Data from these patients is automatically collected routinely as part of the PaceMate remote monitoring database. The data will be sourced from the PaceMate patient registry database into a spreadsheet.

Patient demographics collected will be age, device type, and anticoagulation status (Yes or No) at the close of the 12-month remote-monitoring period.

All AF episodes transmitted during the 12-month study period will be analysed. All AF episodes will be classified according to duration. Episodes occurring within a 24-hour period will be pooled to create a total duration of AF within a 24-hour period.
Pooled episodes will then re-classified into one of four pre-specified AF duration windows:
(1) less than 6 minutes during a 24-hour period,
(2) between 6 minutes and 5 hours 59 minutes during a 24-hour period,
(3) between 6 hours and 23 hours 59 minutes during a 24-hour period, or
(4) over 24 hours.
Patients will then be categorised into one of the four AF duration categories, according to the longest duration of all their episodes. Anticoagulation rates in each AF duration category will be calculated.

Patients who are deemed to be at significant risk of stroke in the setting of AF will then be identified. These patients will be those aged 75 years or older, and those aged 65 to 74 years with a cardiac device in situ suggestive of left ventricular dysfunction (an ICD or cardiac resynchronisation device). Anticoagulation rates in these patient subgroups will be calculated within each of the AF episode duration category.
Intervention code [1] 318126 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324492 0
The primary outcome of the study is the burden of AF episodes transmitted by a cohort of patients with a cardiac implantable electronic device in situ, over a 12-month period; specifically we will be assessing the longest AF episode duration in each patient. AF episodes will be assessed via the PaceMate remote monitoring database.
Timepoint [1] 324492 0
Over a 12-month period of observation
Secondary outcome [1] 384807 0
The secondary outcome of the study is the anticoagulation status of each patient at the end of the 12-month observational period. Anticoagulation status will be assessed via the PaceMate remote monitoring database, where this information is stored.
Timepoint [1] 384807 0
Over a 12-month period of observation

Eligibility
Key inclusion criteria
All patients with a cardiac implantable electronic device (PPM, ICD, or ILR), who were undergoing remote monitoring via the PaceMate remote monitoring service, from November 2018 until November 2019, who transmitted at least one AF episode during the monitoring period.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Continuous data will be expressed as the mean ± standard deviation or median (1st, and 3rd quartiles). Categorical data will be presented as absolute values and percentages. Tests for significance will be conducted using the chi-squared test or Fisher’s exact test for categorical variables. A p value of = 0.05 will be considered significant. All analyses will be performed using commercial software (SPSS version 26.0®, SPSS, Inc., Chicago 5 IL, USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22776 0
United States of America
State/province [1] 22776 0

Funding & Sponsors
Funding source category [1] 306258 0
University
Name [1] 306258 0
The University of Adelaide
Address [1] 306258 0
North Terrace
Adelaide SA 5000
AUSTRALIA
Country [1] 306258 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace
Adelaide SA 5000
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 306746 0
None
Name [1] 306746 0
Address [1] 306746 0
Country [1] 306746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306466 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 306466 0
Royal Adelaide Hospital
Port Rd
Adelaide SA 5000
Ethics committee country [1] 306466 0
Australia
Date submitted for ethics approval [1] 306466 0
20/07/2020
Approval date [1] 306466 0
11/08/2020
Ethics approval number [1] 306466 0

Summary
Brief summary
The primary purpose of this study is to assess the burden of AF episodes in patients with a cardiac device in situ, and the relationship between AF episode duration and rates of anticoagulation for stroke prevention.

AF is associated with a significant risk of ischaemic stroke. Cardiac device-detected AF has now been correlated with elevated stroke risk regardless of the presence or absence of clinical AF symptoms. Anticoagulation reduces both stroke risk and mortality in AF patients. The CHA2DS2-VASc scoring system correlates risk factors to predict the annual stroke risk in AF patients, and guidelines recommend commencing anticoagulation in non-valvular AF patients with a score of at least 2.

Over the past decade, remote monitoring (RM) has evolved as a tool in the management of cardiac implantable electronic devices, and is now a standard component in device follow-up. RM provides physician access to patient/device information in between clinic visits, in the form of both routine transmissions, which act as a surrogate for an in-person device check; and alerts, which may indicate a patient event, programming concern, or device malfunction. RM alerts facilitate early detection of device-detected arrhythmias, including AF, compared with in-clinic follow-up alone. In the absence of RM, AF would be detected only in the event of a routine follow-up, or an unscheduled encountered pertaining to AF symptoms, heart failure, or an embolic event such as a stroke.

Early recognition of device-detected AF via RM presents an opportunity to implement anticoagulation, as well as a rhythm or rate control strategy, in both the asymptomatic patient, and the symptomatic patient who has not yet sought medical attention. Institution of such therapies likely has implications for the associated risks of stroke and heart failure in AF patients.

Using a large clinical cohort of patients undergoing RM via an automated system (Pacemate), we aim to characterize the burden of AF alerts in a cardiac device population undergoing remote monitoring. Specifically, we aim to determine the impact of AF alerts on rates of anticoagulation, in accordance with CHA2DS2-VASc scoring.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103986 0
Dr Catherine O'Shea
Address 103986 0
Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000
Country 103986 0
Australia
Phone 103986 0
+61 8 8313 9000
Fax 103986 0
Email 103986 0
catherine.oshea@adelaide.edu.au
Contact person for public queries
Name 103987 0
Dr Catherine O'Shea
Address 103987 0
Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000
Country 103987 0
Australia
Phone 103987 0
+61 8 8313 9000
Fax 103987 0
Email 103987 0
catherine.oshea@adelaide.edu.au
Contact person for scientific queries
Name 103988 0
Dr Catherine O'Shea
Address 103988 0
Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000
Country 103988 0
Australia
Phone 103988 0
+61 8 8313 9000
Fax 103988 0
Email 103988 0
catherine.oshea@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data belongs to PaceMate remote monitoring company
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary