Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community

Completed

Phase 3 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • 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.

Trial Design

  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Diagnostic
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

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

Sponsors