An observational study in Atrial Fibrillation and Paroxysmal Atrial Fibrillation, sponsored by University of Cambridge. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by University of Cambridge · Observational
--- Background and study aim
Atrial fibrillation (AF) is an irregular heart rhythm which causes a five-fold increase in the risk of stroke. Approximately one in ten people aged over 70 have AF. If AF is recognised then the risk of stroke can be reduced by taking tablets regularly. AF can be difficult to recognise as it can occur without symptoms and only intermittently. Consequently, AF is not recognised in many people, meaning they live with an increased risk of stroke. Therefore, it is important to find ways to identify AF more reliably.
Recently, wearable devices have been developed which could be useful for identifying AF. Several devices can monitor heart activity in daily life, including wristbands, smart watches and chest patch monitors. The aim of this study is to assess the acceptability and performance of wearables for use in AF screening in older adults.
The primary objective is to determine the feasibility of measuring inter-beat-intervals using a wristband. The secondary objectives are:
(i) to determine the acceptability of wearables; (ii) to determine the acceptability of the screening approach; (iii) to assess the performance of wearables for acquiring signals; (iv) to assess the performance of signal processing algorithms; and (v) to assess the performance of wearables for AF screening.
--- Who can participate?
Selected people who have previously participated in the SAFER Programme can participate in this study. The Investigators will invite previous SAFER Programme participants to also participate in this study, aiming to enrol 65 without AF, and 65 with AF.
--- What does the study involve?
Participants will be asked to wear three devices for seven days: Two wristbands (like watches), and one chest patch (like a plaster). These devices will collect measurements of their heart's activity. The Investigators will also ask participants to tell them how they found wearing the devices by completing a questionnaire. The Investigators will compare how participants found wearing each device, and how accurately each device identifies AF.
--- What are the possible benefits and risks of participating?
There will be no direct benefit to participants, although this research is intended to benefit future patients like them. Some participants may experience irritation or redness whilst wearing a chest patch - participants will be advised that if this occurs then they should remove it straightaway.
--- Where is the study run from?
The University of Cambridge.
--- Study procedures
Participants will be asked to:
Participants will be given an instruction leaflet with further details of each step.
3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's planned enrollment of 130 is below the median of 300 across 1,362 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University of Cambridge is the lead sponsor of 112 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Potential participants for the study will be identified from amongst previous participants of the SAFER Programme (ISRCTN 16939438 and ISRCTN 72104369).
Exclusion Criteria:
Participants with a diagnosis of atrial fibrillation (AF) who exhibited AF in previous AF screening (as part of the SAFER Programme).
Device: Electrocardiogram monitoring · Device: Electrocardiogram recording · Device: Photoplethysmogram monitoring · Other: Feedback questionnaire
Participants without a diagnosis of atrial fibrillation (AF) who have previously undergone AF screening (as part of the SAFER Programme).
Device: Electrocardiogram monitoring · Device: Electrocardiogram recording · Device: Photoplethysmogram monitoring · Other: Feedback questionnaire
Continuous monitoring using a wearable, single-lead electrocardiography (ECG) device affixed to the chest.
Intermittent electrocardiogram (ECG) recordings taken using a wearable device on the wrist.
Photoplethysmogram monitoring using a wearable device on the wrist.
A questionnaire to collect feedback on participants' experiences of wearing the devices.
The performance of each wrist-worn wearable approach for identifying AF participants
Sensitivity and specificity
Time frame: 7 days
The time for which participants report wearing the wearables
Duration of time, expressed as median (lower, upper quartiles)
Time frame: 7 days
The number of wrist-ECG recordings taken by participants
Median (lower, upper quartiles)
Time frame: 7 days
The proportion of participants in whom AF was observed, who recorded a wrist-ECG signal during an AF episode
Percentage
Time frame: 7 days
Participant-reported experiences of wearing the wearables
Feedback obtained from questionnaires (including some responses provided on a Likert Scale with options 'Strongly agree', 'Agree', 'Neither agree nor disagree', 'Disagree', and 'Strongly disagree').
Time frame: Day 8
Device packs lost in transit
The number for both outward and return legs
Time frame: Day 1, end of participation
The time for which each device attempts to record signals
The time from the wearable being first applied to the time of either it being finally removed, or its battery running out (whichever occurs first). Expressed as median (lower, upper quartiles)
Time frame: 7 days
The time for which wearable signals are acquired
Duration of time, and proportion of recording time, expressed as median (lower, upper quartiles). 'Wearable signal' is defined as a non-flat-line signal.
Time frame: 7 days
The proportion of recording time for which wearable signals are of high quality
Percentage, expressed as median (lower, upper quartiles)
Time frame: 7 days
The proportion of recording time for which high quality wearable signals are acquired at different times of day
Percentages, expressed as median (lower, upper quartiles)
Time frame: 7 days
The agreement between interbeat-intervals (IBIs) provided by IBI wristbands, and derived from reference ECG chest-patch signals
Limits of Agreement technique (consisting of the bias and limits of agreement)
Time frame: 7 days
The agreement between ECG features derived from wrist-ECGs and reference ECG chest-patch signals.
Limits of Agreement technique (consisting of the bias and limits of agreement)
Time frame: 7 days
The performance of an algorithm to detect AF from wrist-ECG signals
sensitivity and specificity
Time frame: 7 days
The performance of an algorithm to detect possible AF from IBI wristband signals
Sensitivity and specificity
Time frame: 7 days
The proportion of possible AF episodes detected from IBI wristband signals for which the reference ECG exhibited a verified AF episode lasting for ≥ 90 seconds from the start time of the possible episode
Percentage, expressed as median (lower, upper quartiles)
Time frame: 7 days
The agreement between AF burden estimates obtained from wrist devices and the reference ECG chest-patch
Limits of Agreement technique (consisting of the bias and limits of agreement)
Time frame: 7 days
Plan to share: Yes — The following data from individual participants will be anonymised and shared: * Participant characteristics * Quantitative questionnaire data (providing feedback on the wearable devices) * Device data including physiological signals, physiological parameters, and technical parameters.
Supporting information: Study protocol, Icf, Analytic code
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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