Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors

Study Overview
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Brief Summary
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Comparative analysis of available ILR devices models Abbot Confirm RxTM, Medtronic Reveal LINQTM, and Biotronik BIOMONITOR., evaluating detection performance and effective of transmission of these devices to better understand the differences between them.

Detailed Description
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All devices have different algorithms for arrhythmia detection and structural design. Consequently, these devices vary in sensitivity of arrhythmia detection and data transmission.Therefore, we aim to expand a comparative analysis of available devices, evaluating detection performance and effective of transmission of these devices to better understand the differences between them.

Official Title
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Comparative Analysis in Detection of Atrial Arrhythmia and Electrogram Quality in Three Different Insertable Cardiac Monitors

Conditions
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Arrhythmias, Cardiac

Intervention / Treatment
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* Device: Insertion of ILR device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 18 years of age with appropriate indication for ILR for atrial arrhythmia management. Exclusion Criteria: Inability to give consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Abbott Confirm Rx<br>All patients randomized to this group will be implanted Abbott Confirm RX | Device: Insertion of ILR device<br>* All patients enrolled will be randomized to have one of three ILR devices implanted (BIOMONITOR III, Reveal LinQ, or Confirm RX) and will be given event monitoring device for concurrent evaluation.<br>|
| Active Comparator: Medtronic Reveal LINQ<br>All patients randomized to this group will be implanted Medtronic Reveal LINQ | Device: Insertion of ILR device<br>* All patients enrolled will be randomized to have one of three ILR devices implanted (BIOMONITOR III, Reveal LinQ, or Confirm RX) and will be given event monitoring device for concurrent evaluation.<br>|
| Active Comparator: Biotronik Biomonitor<br>All patients randomized to this group will be implanted Biotronik Biomonitor | Device: Insertion of ILR device<br>* All patients enrolled will be randomized to have one of three ILR devices implanted (BIOMONITOR III, Reveal LinQ, or Confirm RX) and will be given event monitoring device for concurrent evaluation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive values of device detected atrial arrhythmias | Positive predictive values of device detected atrial arrhythmias | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Arrhythmias, Implantable loop recorder, Comparative Analysis