ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation

Randomised ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02506621

Acronym

REMAP-AF

Enrollment

Registered

2015-07-23

Start date

2015-09-30

Completion date

2016-01-31

Last updated

2015-07-23

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

Conditions

Atrial Fibrillation

Brief summary

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

Detailed description

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.

Interventions

DEVICER test

DEVICENuubo

DEVICETECHNOMED pocket ECG

DEVICEZIO xt patch

DEVICEMoMe

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* History of Atrial Fibrillation * Dual chamber pacemaker with advanced holter arrhythmia diagnostics

Exclusion criteria

* Previous AV node ablation

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and specificity in detection of pacemaker detected AF burden in comparison to R-test	14 weeks	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.

Secondary

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

Other

Measure	Time frame	Description
User satisfaction in interpretation of reports compare	14 weeks	Ease of interpretation of results summary derived by device software - validated by questionnaire provided to junior & senior Cardiologists and junior & senior Physiologists
Participant feedback on device tolerability assessed by Visual Analogue Score (VAS) questionnaire	14 weeks	Participant feedback on device tolerability assessed by Visual Analogue Score (VAS) questionnaire

Contacts

Primary ContactShunmugam Ragunath Shunmugam, MBBS; MRCP

r.shunmugam@nhs.net01323417400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026