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NCT Number: NCT07291570

Precision Detection and Prediction of Atrial Arrhythmias Using Artificial Intelligence and Consumer Wearable Devices

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust

London, UB9 6JH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. To evaluate the accuracy of an AI algorithm based on PPG-derived metrics in predicting and detecting AF against intermittent rhythm monitoring.

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: REMOTE-AF2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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