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

E

Eastbourne General Hospital

Status

Unknown

Conditions

Atrial Fibrillation

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02506621
REMAP-AF version 1.0

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Previous AV node ablation

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

ELR monitoring
Experimental group
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
Treatment:
Device: TECHNOMED pocket ECG
Device: R test
Device: MoMe
Device: Nuubo
Device: ZIO xt patch

Trial contacts and locations

0

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Central trial contact

Shunmugam Ragunath Shunmugam, MBBS; MRCP

Data sourced from clinicaltrials.gov

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