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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
Scientific title
Accuracy of Implantable Loop Recorders: A Multi-Centre, Multi-Device Comparison in patients over the age of 18
Secondary ID [1] 311959 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
arrhythmia 335642 0
Condition category
Condition code
Cardiovascular 332197 332197 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
14
Target follow-up type
Months
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.

Intervention code [1] 329875 0
Not applicable
Comparator / control treatment
Comparator: LINQ II with AccuRhythm AI (Medtronic, Minneapolis, Minnesota) - MDT
Control group
Active

Outcomes
Primary outcome [1] 339782 0
Accuracy of different implantable loop recorders
Timepoint [1] 339782 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
Primary outcome [2] 339904 0
false positive burden of each loop recorder device
Timepoint [2] 339904 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
Primary outcome [3] 339905 0
positive predictive values of each loop recorder device
Timepoint [3] 339905 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
Secondary outcome [1] 441291 0
True positive rate of each loop recorder device for Atrial tachycardia / atrial fibrillation (AT/AF)
Timepoint [1] 441291 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
Secondary outcome [2] 441880 0
False positive burden of each loop recorder device for Atrial tachycardia / atrial fibrillation (AT/AF)
Timepoint [2] 441880 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
Secondary outcome [3] 441881 0
Positive predictive values of each loop recorder device for Atrial tachycardia / atrial fibrillation (AT/AF)
Timepoint [3] 441881 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
Secondary outcome [4] 442191 0
True positive rate of each loop recorder device for Bradycardia
Timepoint [4] 442191 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
Secondary outcome [5] 442192 0
True positive rate of each loop recorder device for Pause
Timepoint [5] 442192 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
Secondary outcome [6] 442193 0
True positive rate of each loop recorder device for Tachycardia.
Timepoint [6] 442193 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
Secondary outcome [7] 442194 0
False positive burden of each loop recorder device for Bradycardia
Timepoint [7] 442194 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
Secondary outcome [8] 442195 0
False positive burden of each loop recorder device for Pause
Timepoint [8] 442195 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
Secondary outcome [9] 442196 0
False positive burden of each loop recorder device for Tachycardia.
Timepoint [9] 442196 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
Secondary outcome [10] 442197 0
Positive predictive values of each loop recorder device for Bradycardia
Timepoint [10] 442197 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
Secondary outcome [11] 442198 0
Positive predictive values of each loop recorder device for Pause
Timepoint [11] 442198 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.
Secondary outcome [12] 442199 0
Positive predictive values of each loop recorder device for Tachycardia.
Timepoint [12] 442199 0
Any alert transmissions between January 2022 and March 2023 from the randomly selected sample were assessed.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2023
Date of last participant enrolment
Anticipated
Actual
30/04/2024
Date of last data collection
Anticipated
Actual
30/04/2024
Sample size
Target
1140
Accrual to date
Final
1140
Recruitment in Australia
Recruitment state(s)
SA
Recruitment outside Australia
Country [1] 26670 0
United States of America
State/province [1] 26670 0

Funding & Sponsors
Funding source category [1] 316298 0
University
Name [1] 316298 0
University of Adelaide
Country [1] 316298 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 318484 0
None
Name [1] 318484 0
Address [1] 318484 0
Country [1] 318484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315117 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 315117 0
Ethics committee country [1] 315117 0
Australia
Date submitted for ethics approval [1] 315117 0
25/09/2023
Approval date [1] 315117 0
19/10/2023
Ethics approval number [1] 315117 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133722 0
Prof Prashanthan Sanders
Address 133722 0
Royal Adelaide Hospital, Port Rd, Adelaide, SA 5000, Australia
Country 133722 0
Australia
Phone 133722 0
+61 8 8313 9000
Fax 133722 0
Email 133722 0
prash.sanders@adelaide.edu.au
Contact person for public queries
Name 133723 0
Suraya Hani Kamsani
Address 133723 0
University of Adelaide, North Terrace, Adelaide, SA 5000, Australia
Country 133723 0
Australia
Phone 133723 0
+61 406782209
Fax 133723 0
Email 133723 0
surayahani.kamsani@adelaide.edu.au
Contact person for scientific queries
Name 133724 0
Suraya Hani Kamsani
Address 133724 0
University of Adelaide, North Terrace, Adelaide, SA 5000, Australia
Country 133724 0
Australia
Phone 133724 0
+61 406782209
Fax 133724 0
Email 133724 0
surayahani.kamsani@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


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.