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

University of Surrey

Status and phase: Completed; Phase 3

Conditions: Paroxysmal Atrial Fibrillation; Stroke

Treatments: Device: Personal Heart Rhythm Monitor; Device: Automated Cardiac Event Recorder

Study type: Interventional

Funder types: Other

Identifiers

NCT01867060

HASTE-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 194 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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194 participants in 1 patient group

Personal Heart Rhythm Monitor

Other group

Description:

Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor.

Treatment:

Device: Automated Cardiac Event Recorder

Device: Personal Heart Rhythm Monitor