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Trial registered on ANZCTR


Registration number
ACTRN12620000813987
Ethics application status
Approved
Date submitted
12/06/2020
Date registered
14/08/2020
Date last updated
30/06/2021
Date data sharing statement initially provided
14/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
False-Positive Remote Monitoring Alerts in Patients with an Implantable Loop Recorder
Scientific title
Incidence of False-Positive Remote Monitoring Alerts in Patients with an Implantable Loop Recorder
Secondary ID [1] 301509 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Syncope 317848 0
Cardiac arrhythmias 317849 0
Implantable loop recorder 317850 0
Condition category
Condition code
Cardiovascular 315899 315899 0 0
Other cardiovascular diseases

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 remote monitoring alerts, and the rate of false-positive alerts, in patients with an implantable loop recorder (ILR) in situ, who are receiving remote monitoring of their ILR.

Patients who are connected to the PaceMate remote monitoring service during 6-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.

All remote monitoring alerts from patients with a Medtronic ILR in situ, occurring during the 6-month study period (August 2019 until February 2020), will be included. An alert is generated and sent to the remote monitoring service, from the patient's device (ILR) when the device detects an abnormal heart rhythm, or when the patient has symptoms and thus prompts their cardiac device (ILR) to make a recording of their heart rhythm via a remote control.

The only patient demographics collected will be age. Remote monitoring alerts will be collected and recorded according to category at the time of transmission (Asystole, Bradycardia, Atrial fibrillation, Tachycardia, or Patient-Activated).

All alerts will then be re-categorised according to cardiac technician adjudication, as a true-positive alert or a false-positive alert. The underlying reason for false-positive alert transmission (undersensing, frequent ectopy, oversensing, noise/artifact) will be recorded.
Intervention code [1] 317816 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324109 0
The primary outcome of the study is the proportion of false-positive remote monitoring alerts generated by a cohort of patients with an implantable loop recorder (ILR) in situ, over a six month period.
Each remote monitoring alert received from an ILR is accompanied by a rhythm strip which will be assessed by a cardiac device specialist, certified by the International Board of Heart Rhythm Examiners (IBHRE). In the event of an ambiguous rhythm strip the alert analysis will be escalated to a second cardiac device specialist to establish a consensus adjudication. If consensus amongst senior cardiac device specialists is absent the alert analysis will be escalated to an electrophysiologist.
Alerts will be adjudicated as either true-positive or false-positive.
True positive alerts will include all alerts with a rhythm strip consistent with a true arrhythmia, and all patient-activated alerts.
False-positive alerts will include all non-patient-activated alerts with no associated arrhythmia.
Timepoint [1] 324109 0
The primary outcome measure will be assessed daily during in each participant, during the six month study period.
Secondary outcome [1] 383779 0
The secondary outcome of the study is the underlying explanation for each false-positive remote monitoring alert generated by a cohort of patients with an implantable loop recorder in situ, over a six month period.
False-positive alerts occur when the device mistakenly detects an abnormal heart rhythm that has not occurred. Reasons for false-positive alerts include undersensing, oversensing, noise/artifact, and frequent ectopy. The underlying reason for the false-positive alert is determined by assessment of the rhythm strip that accompanies the alert.
The underlying reason for a false-positive alert will be determined by a cardiac device specialist, certified by the International Board of Heart Rhythm Examiners (IBHRE). In the event of an ambiguous rhythm strip the alert analysis will be escalated to a second cardiac device specialist to establish a consensus adjudication. If consensus amongst senior cardiac device specialists is absent the alert analysis will be escalated to an electrophysiologist.
Timepoint [1] 383779 0
The secondary outcome measure will be assessed daily in each participant, during the six-month study period.

Eligibility
Key inclusion criteria
All patients with a Medtronic implantable loop recorder in situ, who were undergoing remote monitoring via the PaceMate remote monitoring service, from 16th August 2019 until 16th February 2020, will be included.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patient who did not send at least one alert during the six-month study period will be excluded, as this is the only way to determine which patients were connected to the remote monitoring service during the study period.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Descriptive statistics will be undertaken via SPSS (version 26, IBM Inc., NY, USA). Categorical variables will be expressed as a percentage and compared via the Pearson’s X2 test. Continuous variables will be expressed as mean ± standard deviation. A two-sided p value of less than 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/08/2020
Actual
29/07/2020
Date of last participant enrolment
Anticipated
18/08/2020
Actual
30/07/2020
Date of last data collection
Anticipated
18/08/2020
Actual
31/07/2020
Sample size
Target
1400
Accrual to date
Final
1470
Recruitment outside Australia
Country [1] 22670 0
United States of America
State/province [1] 22670 0

Funding & Sponsors
Funding source category [1] 305950 0
University
Name [1] 305950 0
The University of Adelaide
Country [1] 305950 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace
Adelaide SA 5000
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 306405 0
None
Name [1] 306405 0
Address [1] 306405 0
Country [1] 306405 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306193 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 306193 0
Royal Adelaide Hospital
Port Rd
Adelaide SA 5000
Ethics committee country [1] 306193 0
Australia
Date submitted for ethics approval [1] 306193 0
12/06/2020
Approval date [1] 306193 0
28/07/2020
Ethics approval number [1] 306193 0
13540

Summary
Brief summary
PRIMARY PURPOSE OF STUDY & STUDY HYPOTHESIS:
The primary purpose of this study is to assess the burden of false-positive alerts for an abnormal heart rhythm in patients who have an implantable loop recorder (ILR).

An ILR is a small recording device that is implanted under the skin overlying the heart. ILRs are implanted in patients with suspected abnormal heart rhythms, usually for symptoms such as blackouts, palpitations, or strokes without a clear explanation. ILRs record abnormal heart rhythms. These recordings are sent as 'alerts' to a remote monitoring service, with daily review of recordings to allow prompt diagnosis of heart arrhythmias.

One small study, conducted over 4 weeks, has shown ILRs to be prone to misdetecting abnormal heart rhythms, and sending alerts that do correspond with a heart arrhythmia; these are known as 'false-positive' alerts.

We aim to explore this phenomenon in a large cohort of 1400 ILR patients over a six-month period, and to determine the reasons for this phenomenon. We hypothesis that the false-positive rate, of ILR alerts will be high.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103038 0
Dr Catherine O'Shea
Address 103038 0
Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000
Country 103038 0
Australia
Phone 103038 0
+61 870740000
Fax 103038 0
Email 103038 0
[email protected]
Contact person for public queries
Name 103039 0
Catherine O'Shea
Address 103039 0
Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000
Country 103039 0
Australia
Phone 103039 0
+61 870740000
Fax 103039 0
Email 103039 0
[email protected]
Contact person for scientific queries
Name 103040 0
Catherine O'Shea
Address 103040 0
Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000
Country 103040 0
Australia
Phone 103040 0
+61 870740000
Fax 103040 0
Email 103040 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
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
No additional documents have been identified.