ANZCTR - Registration

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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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Atrial fibrillation

Stroke

Cardiac implantable electronic device

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Stroke

Ischaemic

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Over a 12-month period of observation

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

30/11/2020

Actual

12/08/2020

Date of last participant enrolment

Anticipated

30/11/2020

Actual

13/08/2020

Date of last data collection

Anticipated

30/11/2020

Actual

14/08/2020

Sample size

Target

6000

Accrual to date

Final

7651

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Adelaide

Address [1]

North Terrace
Adelaide SA 5000
AUSTRALIA

Country [1]

Australia

Primary sponsor type

University

Name

The University of Adelaide

Address

North Terrace
Adelaide SA 5000
AUSTRALIA

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics Committee

Ethics committee address [1]

Royal Adelaide Hospital
Port Rd
Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/07/2020

Approval date [1]

11/08/2020

Ethics approval number [1]

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

Dr Catherine O'Shea

Address

Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000

Country

Australia

Phone

+61 8 8313 9000

Fax

catherine.oshea@adelaide.edu.au

Contact person for public queries

Name

Catherine O'Shea

Address

Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000

Country

Australia

Phone

+61 8 8313 9000

Fax

catherine.oshea@adelaide.edu.au

Contact person for scientific queries

Name

Catherine O'Shea

Address

Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000

Country

Australia

Phone

+61 8 8313 9000

Fax

catherine.oshea@adelaide.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Data belongs to PaceMate remote monitoring company

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

Source	Title	Year of Publication	DOI
Embase	Device-detected atrial fibrillation in a large remote-monitored cohort: implications for anticoagulation and need for new pathways of service delivery.	2023	https://dx.doi.org/10.1007/s10840-023-01481-4

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically