ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Device: R test; Device: Nuubo; Device: TECHNOMED pocket ECG; Device: ZIO xt patch; Device: MoMe

• Registration Number: NCT02506621
• Lead Sponsor: Eastbourne General Hospital

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.

Study Timeline

• Status Verified: 2015-07
• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-21
• Last Update Submitted: 2015-07-21
• Study First Posted: 2015-07-23
• Last Update Posted: 2015-07-23
• Study Start: 2015-09
• Primary Completion: 2015-12
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Previous AV node ablation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ELR monitoring	R test	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
ELR monitoring	Nuubo	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
ELR monitoring	TECHNOMED pocket ECG	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
ELR monitoring	ZIO xt patch	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
ELR monitoring	MoMe	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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