About this trial
Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia affecting over one million people in the UK. It is associated with increased cardiovascular morbidity and mortality and costs the NHS between £1.4 billion and 2.5 billion annually. Current methods to detect AF include opportunistic pulse palpation, single time point 12-lead electrocardiograms (ECGs), ambulatory Holter monitoring, and implantable loop recorders (ILRs). The more widely used intermittent monitoring methods, such as ECGs and Holter monitoring, are limited in terms of duration and have lower detection yields of atrial arrhythmias. At the other end of the spectrum, the ILR can give continuous and accurate arrhythmia detection but is invasive and requires specialist expertise to implant, monitor, and analyse.
In recent years, the use of wearable mobile health (mHealth) devices has emerged as a direct-to-consumer option for monitoring parameters such as heart rate and activity levels. From a clinical perspective they potentially offer a less invasive and cost-effective investigative approach, with remote monitoring solutions to possibly predict and detect AF. This technology has significant potential in terms of passive, non-invasive and continuous monitoring to aid the early diagnosis and management of AF.
The original REMOTE-AF study (NCT05037136) developed novel methodology to detect AF using PPG-dervived data from a wearable. This study will further enhance this foundational work by recruiting patients to develop a AI-enabled, multi-parametric algorithm using PPG-derived data to detect AF.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 and above with a confirmed diagnosis of paroxysmal AF or those who have undergone treatment for paroxysmal, or persistent AF and had sinus rhythm restored.
Capability to provide informed consent, coupled with self-reported sufficiency of digital literacy.
Regular access to a Wi-Fi connection (at least weekly).
Own a smartphone (released after 2017).
Disqualifiers
Individuals with permanent or persistent AF that remains uncontrolled despite receiving treatment.
Conditions or disabilities that preclude adherence to study instructions or proper use of the devices.
A known severe allergy to any of the materials in the wearable or ECG device poses a risk to participant safety.
Trial population
Patients with confirmed diagnosis of paroxysmal AF or persistent AF who have undergone treatment to restore sinus rhythm
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
To evaluate the accuracy of an AI algorithm based on PPG-derived metrics in predicting and detecting AF against intermittent rhythm monitoring.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: