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

Paroxysmal Atrial Fibrillation research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Paroxysmal Atrial Fibrillation

Stroke

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Study Status

Completed

Start Date: May 2013

Completed Date: August 2016

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: 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.

Secondary Outcome: 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).

Study sponsors, principal investigator, and references

Principal Investigator: Philippa Howlett, MBChB BSc

Lead Sponsor: University of Surrey

Collaborator: Royal Surrey County Hospital NHS Foundation Trust

More information:https://clinicaltrials.gov/show/NCT01867060

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