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Completed

NCT Number: NCT01867060

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

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Surrey County Hospital NHS Foundation Trust

Guildford, Surrey, GU2 7XX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspected paroxysmal AF (either palpitations consistent with AF or an irregular pulse)
  • 12-lead resting ECG confirming sinus rhythm
  • Capacity to consent to study
  • English-speaking
  • Life expectancy at least one year

Exclusion criteria

  • Previous diagnosis of AF
  • Recent history of syncope
  • Recent history of cardiac-sounding chest pain
  • A resting ECG suggestive of alternative arrhythmia
  • Inability to use the telephone
  • Thyrotoxicosis

Treatment and study plan

Automated Cardiac Event Recorder

Device

Automated Cardiac Event Recorder to be worn continuously for one week.

Other names: 'R. Test Evolution 4' (Novacor).

Personal Heart Rhythm Monitor

Device

Personal Heart Rhythm Monitor to be used twice-daily for three months.

Other names: 'Portable ECG monitor HCG-801' (OMRON Healthcare).

Primary outcomes

  1. 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.

    Time frame: 18 months

Secondary outcomes

  1. 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).

    Time frame: 18 months

  2. The sensitivity and specificity of serum biomarkers to detect cases of PAF.

    Time frame: 18 months

  3. The sensitivity and specificity of markers of left atrial function to predict PAF.

    Time frame: 18 months

  4. The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period.

    Time frame: 18 months

  5. Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals.

    Time frame: 30 months

  6. Stroke reduction in the local area

    Time frame: 30 months

    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.

  7. Referrals to secondary care for suspected AF/palpitations

    Time frame: 18 months

    The number of referrals to secondary care for suspected PAF will be analysed.

  8. Participant satisfaction with the devices used in the study.

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

University of Surrey

Other

Collaborators

  • Royal Surrey County Hospital NHS Foundation Trust

Registry information

Official study title

Using a Personal Heart Rhythm Monitor (PHRM) to Diagnose Paroxsymal Atrial Fibrillation (PAF) in the Community; and the PREDICT-PAF Substudy - an Investigation of Biomarkers to Detect PAF.

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jun 3, 2013
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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