Crypto PulseOn
Research type
Research Study
Full title
A feasibility study of a wearable arrhythmia monitoring system (PulseON) in stroke patients
IRAS ID
358386
Contact name
Faizel Osman
Contact email
Sponsor organisation
University Hospitals Coventry and Warwickshire NHS Trust
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
Stroke is a serious health issue, with about 100,000 cases each year in the UK, leading to many deaths and long-term disabilities. Most strokes are ischaemic, but in 20-40% of cases, the cause is unknown, termed "cryptogenic stroke." This is more common in younger people but can affect anyone. Atrial fibrillation (AF), the most common heart rhythm disorder, causes 15-30% of ischaemic strokes. However, AF often goes undiagnosed in cryptogenic stroke due to its irregular and symptomless nature. Detecting AF early is crucial as it can significantly reduce stroke risk with proper treatment. Methods to detect AF in standard care vary but implantable loop recorders (ILRs) are the most effective, though invasive and costly. The PulseON Arrhythmia Monitor System, a wrist-worn device, offers a non-invasive way to detect AF by monitoring pulse irregularities and prompting ECG checks. This could improve AF detection, patient outcomes, and hospital resource use, while avoiding invasive procedures. The study will recruit 12 patients who have had a cryptogenic ischaemic stroke or transient ischaemic attack (TIA) within the last 6 months. These patients will undergo standard care and use the PulseON Arrhythmia monitoring system. Data collected will include patient demographics, device usability, and any detected arrhythmias, especially AF. This data will be securely stored and reviewed by healthcare professionals. The main aim of the study is to assess how easy the PulseON device is to use and its impact on patients' lives. Researchers will use interviews to gather feedback from up to 12 participants. The data will be analysed to understand usability and satisfaction. The secondary aims will be to compare the effectiveness of PulseON devices in detecting AF with standard care methods, determine the prevalence of AF in these patients and to develop a business case for the use of PulseON devices in standard care.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
26/NW/0130
Date of REC Opinion
21 May 2026
REC opinion
Favourable Opinion