Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community
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|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|
|Actual Primary Completion Date :||August 2015|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|