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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
R test
Nuubo
TECHNOMED pocket ECG
ZIO xt patch
MoMe
Sponsored by
Eastbourne General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous AV node ablation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ELR monitoring

    Arm 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 R test Nuubo TECHNOMED pocket ECG ZIO xt patch MoMe

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    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
    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
    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

    Full Information

    First Posted
    July 16, 2015
    Last Updated
    July 21, 2015
    Sponsor
    Eastbourne General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02506621
    Brief Title
    ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation
    Acronym
    REMAP-AF
    Official Title
    Randomised ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    January 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Eastbourne General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ELR monitoring
    Arm Type
    Experimental
    Arm 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 R test Nuubo TECHNOMED pocket ECG ZIO xt patch MoMe
    Intervention Type
    Device
    Intervention Name(s)
    R test
    Intervention Type
    Device
    Intervention Name(s)
    Nuubo
    Intervention Type
    Device
    Intervention Name(s)
    TECHNOMED pocket ECG
    Intervention Type
    Device
    Intervention Name(s)
    ZIO xt patch
    Intervention Type
    Device
    Intervention Name(s)
    MoMe
    Primary Outcome Measure Information:
    Title
    Sensitivity and specificity in detection of pacemaker detected AF burden in comparison to R-test
    Description
    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.
    Time Frame
    14 weeks
    Secondary Outcome Measure Information:
    Title
    proportion of pacemaker detected tachyarrhythmias detected in comparison to R-test
    Description
    Proportion of pacemaker detected tachyarrhythmias detected by the ZIO xt patch, MoMe, TECHNOMED pocket ECG and Nuubo in comparison to R-test
    Time Frame
    14 weeks
    Title
    Total wear time in comparison to R-test
    Description
    Total wear time of the ZIO xt patch, MoMe, TECHNOMED pocket ECG and Nuubo in comparison to R-test
    Time Frame
    14 weeks
    Title
    Proportion of symptomatic arrhythmias detected in comparison to R-test
    Description
    Proportion of symptoms secondary to arrhythmias detected by the ZIO xt patch, MoMe, TECHNOMED pocket ECG and Nuubo compared to R-Test
    Time Frame
    14 weeks
    Title
    Cost effectiveness in detection of arrhythmias in comparison to R-test
    Description
    Cost-effectiveness of ZIO xt patch, MoMe, TECHNOMED pocket ECG and Nuubo in detection of arrhythmia in comparison to R-Test
    Time Frame
    14 weeks
    Other Pre-specified Outcome Measures:
    Title
    User satisfaction in interpretation of reports compare
    Description
    Ease of interpretation of results summary derived by device software - validated by questionnaire provided to junior & senior Cardiologists and junior & senior Physiologists
    Time Frame
    14 weeks
    Title
    Participant feedback on device tolerability assessed by Visual Analogue Score (VAS) questionnaire
    Description
    Participant feedback on device tolerability assessed by Visual Analogue Score (VAS) questionnaire
    Time Frame
    14 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History of Atrial Fibrillation Dual chamber pacemaker with advanced holter arrhythmia diagnostics Exclusion Criteria: Previous AV node ablation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shunmugam Ragunath Shunmugam, MBBS; MRCP
    Phone
    01323417400
    Ext
    4132
    Email
    r.shunmugam@nhs.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Neil Sulke, DM, FRCP
    Organizational Affiliation
    Eastbourne General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation

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