Precision Detection and Prediction of Atrial Arrhythmias Using Artificial Intelligence and Consumer Wearable Devices (REMOTE-AF2)

Royal Brompton & Harefield NHS Foundation Trust

Status: Not yet enrolling

Conditions: Atrial Fibrillation (AF)

Study type: Observational

Funder types: Other

Identifiers

NCT07291570

354811

C0118: RFSG-26/2 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Capability to provide informed consent, coupled with self-reported sufficiency of digital literacy.
3. Regular access to a Wi-Fi connection (at least weekly).
4. Own a smartphone (released after 2017).

Exclusion criteria

1. Individuals with permanent or persistent AF that remains uncontrolled despite receiving treatment.
2. Conditions or disabilities that preclude adherence to study instructions or proper use of the devices.
3. A known severe allergy to any of the materials in the wearable or ECG device poses a risk to participant safety.

Trial design

40 participants in 1 patient group

Wearable