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

July 21, 2015 updated by: Neil Sulke, Eastbourne General Hospital

Randomised ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous AV node ablation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ELR monitoring

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of pacemaker detected tachyarrhythmias detected in comparison to R-test
Time Frame: 14 weeks
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
Time Frame: 14 weeks
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
Time Frame: 14 weeks
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
Time Frame: 14 weeks
Cost-effectiveness of ZIO xt patch, MoMe, TECHNOMED pocket ECG and Nuubo in detection of arrhythmia in comparison to R-Test
14 weeks

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastbourne General Hospital

Investigators

  • Principal Investigator: Neil Sulke, DM, FRCP, Eastbourne General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (Estimate)

July 23, 2015

Study Record Updates

Last Update Posted (Estimate)

July 23, 2015

Last Update Submitted That Met QC Criteria

July 21, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REMAP-AF version 1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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