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| Name | Class |
|---|---|
| Royal Surrey County Hospital NHS Foundation Trust | OTHER |
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This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial Fibrillation PAF). The investigators hypothesise that the PHRM, used intermittently for 3 months, will detect significantly more cases of PAF than the ACER, used continuously for one week.
A case-control sub-study will identify individuals with confirmed PAF, and matched individuals with no evidence of PAF, to identify potential serum biomarkers for PAF.
A further case-control study will assess markers of left atrial function in patients with PAF and their matched controls.
Another case-control sub-study will determine the significance of frequent Atrial Premature Beats (APBs) in the development of AF over a one year period.
Patients with suspected AF will be initially referred to a community-based, nurse-led Arrhythmia clinic by their General Practitioners over a 15-month period.
All patients will be issued with a one week ACER (the 'R. Test 4 Evolution'), seen as the 'best-practice' investigation for this population group. Participants will also be issued with a PHRM for three months. They will be instructed to take regular twice-daily, 30 second recordings with additional recordings in the event of relevant symptoms. They will return the ACER after one week and the PHRM after 3 months.
A subgroup of participants (target recruitment number = 100) will undergo transthoracic echocardiography. A 40ml venous blood sample will also be taken. Another small subgroup (target recruitment = 20) will be asked to continue twice-daily recordings using the PHRM for a further nine months and will be issued with a repeat one week ACER at study completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personal Heart Rhythm Monitor | Other | Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated Cardiac Event Recorder | Device | Automated Cardiac Event Recorder to be worn continuously for one week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect all episodes of paroxysmal atrial fibrillation. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect prolonged episodes of paroxysmal atrial fibrillation (defined as greater than 12 hours). | 18 months | |
| The sensitivity and specificity of serum biomarkers to detect cases of PAF. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippa Howlett, MBChB BSc | The Royal Surrey County Hospital | Principal Investigator |
| Edward Leatham, MBChB MD | The Royal Surrey County Hospital | Study Director |
| Chris Fry, BSc PhD | The University of Surrey | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Surrey County Hospital NHS Foundation Trust | Guildford | Surrey | GU2 7XX | United Kingdom |
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| Label | URL |
|---|---|
| HASTE charity website | View source |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Personal Heart Rhythm Monitor | Device | Personal Heart Rhythm Monitor to be used twice-daily for three months. |
|
|
| 18 months |
| The sensitivity and specificity of markers of left atrial function to predict PAF. | 18 months |
| The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period. | 18 months |
| Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals. | 30 months |
| Stroke reduction in the local area | A reduction in stroke burden in the local area will be calculated from estimated stroke risk in individuals identified with AF and from a local registry. | 30 months |
| Referrals to secondary care for suspected AF/palpitations | The number of referrals to secondary care for suspected PAF will be analysed. | 18 months |
| Participant satisfaction with the devices used in the study. | 18 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |