ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation

Study Overview
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Brief Summary
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Randomised crossover study comparing the sensitivity and specificity of 5 External loop recorders in detecting pacemaker detected Atrial fibrillation burden.

Detailed Description
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The purpose of the study is to compare the diagnostic accuracy of the ZIO xt , MoMe, TECHNOMED pocket ECG and Nuubo to the R-test, our current standard clinical practice, in detection of AF burden, in patients with history of Paroxysmal Atrial Fibrillation and have a dual chamber pacemaker or ICD in situ, with sensitivity and specificity of AF detection calculated from the implanted pacemaker monitored beat to beat holters.

Official Title
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Randomised ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: R test
* Device: Nuubo
* Device: TECHNOMED pocket ECG
* Device: ZIO xt patch
* Device: MoMe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of Atrial Fibrillation Dual chamber pacemaker with advanced holter arrhythmia diagnostics Exclusion Criteria: Previous AV node ablation
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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ELR monitoring<br>Single arm study. All participants with existing permanent dual chamber pacemakers will be monitored with 5 different Loop recorder devices for a 2 week period to assess there sensitivity and specificity in detecting AF burden. The devices used will be R test Nuubo TECHNOMED pocket ECG ZIO xt patch MoMe | Device: R test<br> <br> Device: Nuubo<br> <br> Device: TECHNOMED pocket ECG<br> <br> Device: ZIO xt patch<br> <br> Device: MoMe<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity in detection of pacemaker detected AF burden in comparison to R-test | Sensitivity and specificity of ZIO xt patch, MoMe, TECHNOMED pocket ECG AND Nuubo in detection of pacemaker detected AF burden in comparison to R-test. Sensitivity and sepcificity will be determined by the percentage of pacemaker detected AF episodes that have been detected by each ELR device. | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of pacemaker detected tachyarrhythmias detected in comparison to R-test | Proportion of pacemaker detected tachyarrhythmias detected by the ZIO xt patch, MoMe, TECHNOMED pocket ECG and Nuubo in comparison to R-test | 14 weeks | 
| Total wear time in comparison to R-test | Total wear time of the ZIO xt patch, MoMe, TECHNOMED pocket ECG and Nuubo in comparison to R-test | 14 weeks | 
| Proportion of symptomatic arrhythmias detected in comparison to R-test | Proportion of symptoms secondary to arrhythmias detected by the ZIO xt patch, MoMe, TECHNOMED pocket ECG and Nuubo compared to R-Test | 14 weeks | 
| Cost effectiveness in detection of arrhythmias in comparison to R-test | Cost-effectiveness of ZIO xt patch, MoMe, TECHNOMED pocket ECG and Nuubo in detection of arrhythmia in comparison to R-Test | 14 weeks |