Smart in OAC - AFNET 9
Research type
Research Study
Full title
Multi-centre, multi-national, investigator-initiated, single-arm, case-finding study of a cloud based analytic service as screening tool to detect and quantify episodes of atrial arrhythmia using an automated, wearable photoplethysmography-based monitoring system
IRAS ID
292218
Contact name
Derek Connolly
Contact email
Sponsor organisation
Atrial Fibrillatin NETwork (AFNET) / Kompetenznetz Vorhofflimmern e.V.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Atrial fibrillation (AF) is a common cause of stroke, especially ischemic stroke. Early initiation of anticoagulation can prevent stroke and systemic embolism, and reduce cardiovascular mortality in patients. It is well established that a large proportion of AF episodes remain undiagnosed (“silent AF”), and many patients with “silent AF” present with a stroke as the first clinical sign of AF. An earlier detection of AF using established diagnostics remains difficult to organise, often preventing timely initiation of oral anticoagulation.
Hence, there is a societal need to test whether accessible, patient-operated technologies can be used to enable screening for atrial arrhythmias including “silent AF” in at-risk populations. There are more smartphones than people on earth. Smartphones and increasingly wearables are widely used in the population and they can be used to detect rhythm abnormalities, albeit with limited specificity and sensitivity compared to medical devices.
Screening for “silent AF” is most needed in elderly populations. Hence, we propose to test the hypothesis that systematic screening for an irregular atrial rhythm (‘atrial arrhythmia’, AA) in at-risk populations, offering a wristband combined with a robust algorithm analysing biosignals from smartphones and wearables, is feasible and leads to earlier detection of silent AF in an unselected, elderly population.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
21/WM/0221
Date of REC Opinion
4 Nov 2021
REC opinion
Further Information Favourable Opinion