Atrial FibrillationREMAP-AFNCT02506621
ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation
A study testing R test, Nuubo and TECHNOMED pocket ECG in people with Atrial Fibrillation, run by East Sussex Healthcare NHS Trust.
Trial summary
Randomised crossover study comparing the sensitivity and specificity of 5 External loop recorders in detecting pacemaker detected Atrial fibrillation burden. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- R test, Nuubo and TECHNOMED pocket ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of Atrial Fibrillation
- Dual chamber pacemaker with advanced holter arrhythmia diagnostics
Who cannot join
- Previous AV node ablation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomised ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation
Randomised crossover study comparing the sensitivity and specificity of 5 External loop recorders in detecting pacemaker detected Atrial fibrillation burden.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- R test, Nuubo, TECHNOMED pocket ECG, ZIO xt patch, MoMe
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R testDevice
NuuboDevice
TECHNOMED pocket ECGDevice
ZIO xt patchDevice
MoMeDevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: R test; Device: Nuubo; Device: TECHNOMED pocket ECG; Device: ZIO xt patch; Device: MoMe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 weeks
Secondary outcomes (4)
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
Measured: 14 weeks
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
Measured: 14 weeks
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
Measured: 14 weeks
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
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Sussex Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Sulke, East Sussex Healthcare NHS Trust
- Investigators
- Neil Sulke, DM, FRCP, Principal investigator, East Sussex Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506621
- Sponsor's protocol ID
- REMAP-AF version 1.0
- Acronym
- REMAP-AF
- Status last verified
- Jul 2015
- First submitted
- 16 Jul 2015
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02506621
- Acronym / sponsor ID
- REMAP-AF / REMAP-AF version 1.0
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- East Sussex Healthcare NHS TrustUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ELR monitoring | Experimental | Device: R test, Device: Nuubo, Device: TECHNOMED pocket ECG, Device: ZIO xt patch, Device: MoMeSingle 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- History of Atrial Fibrillation
- Dual chamber pacemaker with advanced holter arrhythmia diagnostics
Key exclusion criteria (1 listed)
- Previous AV node ablation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R test | Device | ELR monitoring |
| Nuubo | Device | ELR monitoring |
| TECHNOMED pocket ECG | Device | ELR monitoring |
| ZIO xt patch | Device | ELR monitoring |
| MoMe | Device | ELR monitoring |
Primary outcome
Sensitivity and specificity in detection of pacemaker detected AF burden in comparison to R-test
Time frame: 14 weeks
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.
4 secondary outcomes
proportion of pacemaker detected tachyarrhythmias detected in comparison to R-test
Time frame: 14 weeks
Total wear time in comparison to R-test
Time frame: 14 weeks
Proportion of symptomatic arrhythmias detected in comparison to R-test
Time frame: 14 weeks
Cost effectiveness in detection of arrhythmias in comparison to R-test
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Sulke, DM, FRCP principal investigator
East Sussex Healthcare NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing R test, Nuubo and TECHNOMED pocket ECG in people with Atrial Fibrillation, run by East Sussex Healthcare NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shunmugam Ragunath Shunmugam, MBBS; MRCP (01323417400 ext. 4132, r.shunmugam@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity in detection of pacemaker detected AF burden in comparison to R-test (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.