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Randomised crossover study comparing the sensitivity and specificity of 5 External loop recorders in detecting pacemaker detected Atrial fibrillation burden.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R test | Device |
| ||
| Nuubo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Total wear time in comparison to R-test |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Participant feedback on device tolerability assessed by Visual Analogue Score (VAS) questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shunmugam Ragunath Shunmugam, MBBS; MRCP | Contact | 01323417400 | 4132 | r.shunmugam@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Neil Sulke, DM, FRCP | Eastbourne General Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| TECHNOMED pocket ECG | Device |
|
| ZIO xt patch | Device |
|
| MoMe | Device |
|
Total wear time of the ZIO xt patch, MoMe, TECHNOMED pocket ECG and Nuubo in comparison to R-test |
| 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 | 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 | 14 weeks |
Participant feedback on device tolerability assessed by Visual Analogue Score (VAS) questionnaire |
| 14 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |