ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation (REMAP-AF)

Eastbourne General Hospital

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Device: MoMe; Device: Nuubo; Device: R test; Device: TECHNOMED pocket ECG; Device: ZIO xt patch

Study type: Interventional

Funder types: Other

Identifiers

NCT02506621

REMAP-AF version 1.0

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Previous AV node ablation

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

ELR monitoring

Experimental group

Description:

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 1. R test 2. Nuubo 3. TECHNOMED pocket ECG 4. ZIO xt patch 5. MoMe

Treatment:

Device: TECHNOMED pocket ECG

Device: ZIO xt patch

Device: MoMe

Device: Nuubo

Device: R test