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Trial registered on ANZCTR
Registration number
ACTRN12624001398594
Ethics application status
Approved
Date submitted
3/11/2024
Date registered
26/11/2024
Date last updated
26/11/2024
Date data sharing statement initially provided
26/11/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Comparison of accuracy between different implantable loop recorders
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Scientific title
Accuracy of Implantable Loop Recorders: A Multi-Centre, Multi-Device Comparison in patients over the age of 18
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Secondary ID [1]
311959
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
arrhythmia
335642
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Condition category
Condition code
Cardiovascular
332197
332197
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
14
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Target follow-up type
Months
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Description of intervention(s) / exposure
Alert transmissions from a multi-centre, multi-vendor database of 4 different implantable loop recorders will be compared. The loop recorders being compared are: LINQ II with AccuRhythm AI (Medtronic, Minneapolis, Minnesota) - MDT, Confirm Rx with SharpSense Technology (Abbott, Sylmar, CA) - ABT, Biomonitor III with RhythmCheck (Biotronik, Berlin, Germany) - BIO, LUX-DxTM with Dual-Stage Algorithm (Boston Scientific) - BSX.
There will be no direct participation from patients. Only baseline characteristics and details of alert transmission from PaceMate LIVE database were extracted. Consent waiver were requested and approved. Patients are aware of their data being used due to the HIPAA agreement in which PaceMate are permitted to share deidentified data sets or limited data sets with restricted protected health information (PHI) elements without permission from the covered entity or a patient.
This study was an analysis of a large multi-centre, multi-vendor database of patients with ILR receiving remote monitoring (RM) using PaceMate LIVE over a 15-month period (between January 2022 and March 2023). PaceMate LIVE is a software platform that automatically consolidates all remote monitoring transmissions and alerts from various device manufacturers into one streamlined user interface.
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Intervention code [1]
329875
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Not applicable
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Comparator / control treatment
Comparator: LINQ II with AccuRhythm AI (Medtronic, Minneapolis, Minnesota) - MDT
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Control group
Active
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Outcomes
Primary outcome [1]
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positive predictive values of each loop recorder device
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Assessment method [1]
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The PPV is calculated based on the true positive and false positive rates obtained from the adjudication
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Timepoint [1]
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Primary outcome [2]
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false positive burden of each loop recorder device
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Assessment method [2]
339904
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Assessment method: Alert transmissions with available ECG were independently and manually adjudicated by two trained physicians. The adjudication was determined as true positive (TP) or false positive (FP) with reasons for FP recorded. The decision was deemed final if both reviewers agreed. In the case of an uncertain or discordant diagnosis, the ECG was reviewed by a third investigator and discussed to reach a consensus. All reviewers were blinded to patient clinical information.
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Timepoint [2]
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Primary outcome [3]
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Accuracy of different implantable loop recorders
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Assessment method [3]
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True positive rate of each loop recorder device Assessment method: Alert transmissions with available ECG were independently and manually adjudicated by two trained physicians. The adjudication was determined as true positive (TP) or false positive (FP) with reasons for FP recorded. The decision was deemed final if both reviewers agreed. In the case of an uncertain or discordant diagnosis, the ECG was reviewed by a third investigator and discussed to reach a consensus. All reviewers were blinded to patient clinical information.
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Timepoint [3]
339782
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Secondary outcome [1]
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Positive predictive values of each loop recorder device for Atrial tachycardia / atrial fibrillation (AT/AF)
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Assessment method [1]
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The PPV is calculated based on the true positive and false positive rates obtained from the adjudication.
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Timepoint [1]
441881
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Secondary outcome [2]
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True positive rate of each loop recorder device for Atrial tachycardia / atrial fibrillation (AT/AF)
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Assessment method [2]
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Alert transmissions with available ECG were independently and manually adjudicated by two trained physicians. The adjudication was determined as true positive (TP) or false positive (FP) with reasons for FP recorded. The decision was deemed final if both reviewers agreed. In the case of an uncertain or discordant diagnosis, the ECG was reviewed by a third investigator and discussed to reach a consensus. All reviewers were blinded to patient clinical information.
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Timepoint [2]
441291
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Secondary outcome [3]
442193
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True positive rate of each loop recorder device for Tachycardia.
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Assessment method [3]
442193
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Alert transmissions with available ECG were independently and manually adjudicated by two trained physicians. The adjudication was determined as true positive (TP) or false positive (FP) with reasons for FP recorded. The decision was deemed final if both reviewers agreed. In the case of an uncertain or discordant diagnosis, the ECG was reviewed by a third investigator and discussed to reach a consensus. All reviewers were blinded to patient clinical information.
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Timepoint [3]
442193
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Secondary outcome [4]
441880
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False positive burden of each loop recorder device for Atrial tachycardia / atrial fibrillation (AT/AF)
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Assessment method [4]
441880
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Alert transmissions with available ECG were independently and manually adjudicated by two trained physicians. The adjudication was determined as true positive (TP) or false positive (FP) with reasons for FP recorded. The decision was deemed final if both reviewers agreed. In the case of an uncertain or discordant diagnosis, the ECG was reviewed by a third investigator and discussed to reach a consensus. All reviewers were blinded to patient clinical information.
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Timepoint [4]
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Secondary outcome [5]
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True positive rate of each loop recorder device for Bradycardia
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Assessment method [5]
442191
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Alert transmissions with available ECG were independently and manually adjudicated by two trained physicians. The adjudication was determined as true positive (TP) or false positive (FP) with reasons for FP recorded. The decision was deemed final if both reviewers agreed. In the case of an uncertain or discordant diagnosis, the ECG was reviewed by a third investigator and discussed to reach a consensus. All reviewers were blinded to patient clinical information.
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Timepoint [5]
442191
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Secondary outcome [6]
442199
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Positive predictive values of each loop recorder device for Tachycardia.
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Assessment method [6]
442199
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The PPV is calculated based on the true positive and false positive rates obtained from the adjudication.
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Timepoint [6]
442199
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Secondary outcome [7]
442194
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False positive burden of each loop recorder device for Bradycardia
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Assessment method [7]
442194
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Alert transmissions with available ECG were independently and manually adjudicated by two trained physicians. The adjudication was determined as true positive (TP) or false positive (FP) with reasons for FP recorded. The decision was deemed final if both reviewers agreed. In the case of an uncertain or discordant diagnosis, the ECG was reviewed by a third investigator and discussed to reach a consensus. All reviewers were blinded to patient clinical information.
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Timepoint [7]
442194
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Secondary outcome [8]
442192
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True positive rate of each loop recorder device for Pause
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Assessment method [8]
442192
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Alert transmissions with available ECG were independently and manually adjudicated by two trained physicians. The adjudication was determined as true positive (TP) or false positive (FP) with reasons for FP recorded. The decision was deemed final if both reviewers agreed. In the case of an uncertain or discordant diagnosis, the ECG was reviewed by a third investigator and discussed to reach a consensus. All reviewers were blinded to patient clinical information.
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Timepoint [8]
442192
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Secondary outcome [9]
442195
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False positive burden of each loop recorder device for Pause
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Assessment method [9]
442195
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Alert transmissions with available ECG were independently and manually adjudicated by two trained physicians. The adjudication was determined as true positive (TP) or false positive (FP) with reasons for FP recorded. The decision was deemed final if both reviewers agreed. In the case of an uncertain or discordant diagnosis, the ECG was reviewed by a third investigator and discussed to reach a consensus. All reviewers were blinded to patient clinical information.
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Timepoint [9]
442195
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Secondary outcome [10]
442197
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Positive predictive values of each loop recorder device for Bradycardia
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Assessment method [10]
442197
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The PPV is calculated based on the true positive and false positive rates obtained from the adjudication.
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Timepoint [10]
442197
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Secondary outcome [11]
442198
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Positive predictive values of each loop recorder device for Pause
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Assessment method [11]
442198
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The PPV is calculated based on the true positive and false positive rates obtained from the adjudication.
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Timepoint [11]
442198
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Secondary outcome [12]
442196
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False positive burden of each loop recorder device for Tachycardia.
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Assessment method [12]
442196
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Alert transmissions with available ECG were independently and manually adjudicated by two trained physicians. The adjudication was determined as true positive (TP) or false positive (FP) with reasons for FP recorded. The decision was deemed final if both reviewers agreed. In the case of an uncertain or discordant diagnosis, the ECG was reviewed by a third investigator and discussed to reach a consensus. All reviewers were blinded to patient clinical information.
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Timepoint [12]
442196
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Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
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Eligibility
Key inclusion criteria
Patients over 18 years of age with implantable loop recorder (ILR) with remote monitoring transmission using PaceMate LIVE between January 2022 to March 2023
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
-Patients under 18 years of age
-Patients with devices other than ILR including permanent pacemakers and defibrillators
-Patients with a Sorin device as these are not currently available on the PaceMate platform
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Random sample
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/11/2023
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Date of last participant enrolment
Anticipated
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Actual
30/04/2024
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Date of last data collection
Anticipated
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Actual
30/04/2024
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Sample size
Target
1140
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Accrual to date
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Final
1140
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment outside Australia
Country [1]
26670
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United States of America
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State/province [1]
26670
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Funding & Sponsors
Funding source category [1]
316298
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University
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Name [1]
316298
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University of Adelaide
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Address [1]
316298
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Country [1]
316298
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Australia
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Primary sponsor type
University
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Name
University of Adelaide
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Address
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Country
Australia
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Secondary sponsor category [1]
318484
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None
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Name [1]
318484
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Address [1]
318484
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Country [1]
318484
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315117
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
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https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
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Ethics committee country [1]
315117
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Australia
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Date submitted for ethics approval [1]
315117
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25/09/2023
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Approval date [1]
315117
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19/10/2023
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Ethics approval number [1]
315117
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Summary
Brief summary
This study is a retrospective, observational study comparing 4 different implantable loop recorders in terms of their accuracy in detecting different arrhythmia episode types. We hypothesized that there is no significant difference in accuracy between the different devices and episode types.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Prashanthan Sanders
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Address
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Royal Adelaide Hospital, Port Rd, Adelaide, SA 5000, Australia
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Country
133722
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Australia
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Phone
133722
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+61 8 8313 9000
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Fax
133722
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Email
133722
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[email protected]
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Contact person for public queries
Name
133723
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Suraya Hani Kamsani
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Address
133723
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University of Adelaide, North Terrace, Adelaide, SA 5000, Australia
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Country
133723
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Australia
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Phone
133723
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+61 406782209
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Fax
133723
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Email
133723
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[email protected]
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Contact person for scientific queries
Name
133724
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Suraya Hani Kamsani
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Address
133724
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University of Adelaide, North Terrace, Adelaide, SA 5000, Australia
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Country
133724
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Australia
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Phone
133724
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+61 406782209
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Fax
133724
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Email
133724
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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.
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