Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community
|ClinicalTrials.gov Identifier: NCT01867060|
Recruitment Status : Completed
First Posted : June 3, 2013
Last Update Posted : April 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation Stroke||Device: Automated Cardiac Event Recorder Device: Personal Heart Rhythm Monitor||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||194 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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.|
|Study Start Date :||May 2013|
|Primary Completion Date :||August 2015|
|Study Completion Date :||August 2016|
Personal Heart Rhythm Monitor
Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor.
Device: Automated Cardiac Event Recorder
Automated Cardiac Event Recorder to be worn continuously for one week.
Other Name: 'R. Test Evolution 4' (Novacor).Device: Personal Heart Rhythm Monitor
Personal Heart Rhythm Monitor to be used twice-daily for three months.
Other Name: 'Portable ECG monitor HCG-801' (OMRON Healthcare).
- 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 ]
- 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 ]
- The sensitivity and specificity of serum biomarkers to detect cases of PAF. [ Time Frame: 18 months ]
- The sensitivity and specificity of markers of left atrial function to predict PAF. [ Time Frame: 18 months ]
- The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period. [ Time Frame: 18 months ]
- Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals. [ Time Frame: 30 months ]
- 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.
- 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.
- Participant satisfaction with the devices used in the study. [ Time Frame: 18 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867060
|Royal Surrey County Hospital NHS Foundation Trust|
|Guildford, Surrey, United Kingdom, GU2 7XX|
|Principal Investigator:||Philippa Howlett, MBChB BSc||The Royal Surrey County Hospital|
|Study Director:||Edward Leatham, MBChB MD||The Royal Surrey County Hospital|
|Study Director:||Chris Fry, BSc PhD||The University of Surrey|