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.
- Automated Cardiac Event Recorder Device
Other Names: 'R. Test Evolution 4' (Novacor). Intervention Desc: Automated Cardiac Event Recorder to be worn continuously for one week. ARM 1: Kind: Experimental Label: Personal Heart Rhythm Monitor Description: Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor.
- Personal Heart Rhythm Monitor Device
Other Names: 'Portable ECG monitor HCG-801' (OMRON Healthcare). Intervention Desc: Personal Heart Rhythm Monitor to be used twice-daily for three months. ARM 1: Kind: Experimental Label: Personal Heart Rhythm Monitor Description: Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor.
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Diagnostic
- Endpoint: Safety/Efficacy Study
- Intervention: Single Group Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||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||No|
|Secondary||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||No|
|Secondary||The sensitivity and specificity of serum biomarkers to detect cases of PAF.||18 months||No|
|Secondary||The sensitivity and specificity of markers of left atrial function to predict PAF.||18 months||No|
|Secondary||The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period.||18 months||No|
|Secondary||Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals.||30 months||Yes|
|Secondary||Stroke reduction in the local area||30 months||Yes|
|Secondary||Referrals to secondary care for suspected AF/palpitations||18 months||No|
|Secondary||Participant satisfaction with the devices used in the study.||18 months||No|
|Secondary||The sensitivity and specificity of serum biomarkers to detect cases of PAF.||18 months|