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
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation
Eligibility Criteria
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
NCT ID
NCT02506621
First Posted
July 16, 2015
Last Updated
July 21, 2015
Sponsor
Eastbourne General Hospital
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
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ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation
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