Comparison of accuracy between different implantable loop recorders

Accuracy of Implantable Loop Recorders: A Multi-Centre, Multi-Device Comparison in patients over the age of 18

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12624001398594

Enrollment

1140

Registered

2024-11-26

Start date

2023-11-01

Completion date

2024-04-30

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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

Outcome results