NCT02506621

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable atrial-fibrillation

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

July 16, 2015

Last Update Submit

July 21, 2015

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • proportion of pacemaker detected tachyarrhythmias detected in comparison to R-test

    14 weeks

  • Total wear time in comparison to R-test

    14 weeks

  • Proportion of symptomatic arrhythmias detected in comparison to R-test

    14 weeks

  • Cost effectiveness in detection of arrhythmias in comparison to R-test

    14 weeks

Other Outcomes (2)

  • User satisfaction in interpretation of reports compare

    14 weeks

  • Participant feedback on device tolerability assessed by Visual Analogue Score (VAS) questionnaire

    14 weeks

Study Arms (1)

ELR monitoring

EXPERIMENTAL

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 testDevice: NuuboDevice: TECHNOMED pocket ECGDevice: ZIO xt patchDevice: MoMe

Interventions

R testDEVICE
ELR monitoring
NuuboDEVICE
ELR monitoring
TECHNOMED pocket ECGDEVICE
ELR monitoring
ZIO xt patchDEVICE
ELR monitoring
MoMeDEVICE
ELR monitoring

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous AV node ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Neil Sulke, DM, FRCP

    Eastbourne General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shunmugam Ragunath Shunmugam, MBBS; MRCP

CONTACT

01323417400r.shunmugam@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 23, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

July 23, 2015

Record last verified: 2015-07