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

Phase 3

Completed

• Conditions: Paroxysmal Atrial Fibrillation; Stroke
• Interventions: Device: Automated Cardiac Event Recorder; Device: Personal Heart Rhythm Monitor

• Registration Number: NCT01867060
• Lead Sponsor: University of Surrey

Brief Summary

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-05-31
• Study First Posted: 2013-06-03
• Primary Completion: 2015-08
• Study Completion: 2016-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
The sensitivity and specificity of markers of left atrial function to predict PAF.	18 months
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 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
The sensitivity and specificity of serum biomarkers to detect cases of PAF.	18 months
Stroke reduction in the local area	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.
Referrals to secondary care for suspected AF/palpitations	18 months	The number of referrals to secondary care for suspected PAF will be analysed.
Participant satisfaction with the devices used in the study.	18 months

Trial Locations

Locations (1)

Royal Surrey County Hospital NHS Foundation Trust; 🇬🇧 Guildford, Surrey, United Kingdom