ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— REMAP-AF  

Official title:

Randomised ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02506621
• Other study ID #: REMAP-AF version 1.0
• Status: Not yet recruiting
• Phase: N/A
• First received: July 16, 2015
• Last updated: July 21, 2015
• Start date: September 2015
• Est. completion date: January 2016

Study information

• Verified date: July 2015
• Source: Eastbourne General Hospital
• Contact: Shunmugam Ragunath Shunmugam, MBBS; MRCP
• Phone: 01323417400
• Email: r.shunmugam[@]nhs.net
• Is FDA regulated: No
• Health authority: Research Ethics Committee United Kingdom: South East Coast - Brighton and Sussex
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• History of Atrial Fibrillation

• Dual chamber pacemaker with advanced holter arrhythmia diagnostics

Exclusion Criteria:

• Previous AV node ablation

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• R test

• Nuubo

• TECHNOMED pocket ECG

• ZIO xt patch

• MoMe

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eastbourne General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	User satisfaction in interpretation of reports compare	Ease of interpretation of results summary derived by device software - validated by questionnaire provided to junior & senior Cardiologists and junior & senior Physiologists	14 weeks	No
Other	Participant feedback on device tolerability assessed by Visual Analogue Score (VAS) questionnaire	Participant feedback on device tolerability assessed by Visual Analogue Score (VAS) questionnaire	14 weeks	No
Primary	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.	14 weeks	No
Secondary	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	14 weeks	No
Secondary	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	14 weeks	No
Secondary	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	14 weeks	No
Secondary	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	14 weeks	No