CSAF-AW study
Research type
Research Study
Full title
A non-invasive, prolonged surveillance strategy using Apple watch for atrial fibrillation detection in cryptogenic stroke
IRAS ID
284826
Contact name
Richard Schilling
Contact email
Sponsor organisation
Barts Health NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
No cause for stroke is found in up to 30% of cases despite extensive investigations. These are called cryptogenic strokes (CS). 1 in 4 stroke survivors will suffer another in 5 years and this is a leading cause of fear and anxiety. A common reason for CS is an undetected heart rhythm disorder called atrial fibrillation (AF). AF occurs intermittently, so it may not be detected during the mandated 24-96 hours of rhythm monitoring that is performed as part of the standard post-stroke investigation strategy.
A randomised controlled study in 2014 showed that this standard monitoring strategy picks up AF in 2% of CS patients, but continuous monitoring for 12 months using an implantable recording device can pick up AF in 13% of patients. This suggests the standard strategy may miss AF in a proportion of CS patients and thus also the opportunity to mitigate against further strokes with anticoagulation therapy. Long-term monitoring has traditionally required a minimally-invasive surgical procedure to implant a recording device under the skin at a specialist centre. A specifically trained team is also required to interpret the large number of recordings this strategy yields.
The Apple Watch (AW) is a wristwatch able to monitor a wearer’s heart rate and rhythm regularity and facilitates real-time, single-lead ECG recordings. This over-the-counter, non-invasive device has demonstrated feasibility and has a CE Mark for detecting AF. It may offer a potential non-invasive alternative long-term rhythm surveillance strategy to diagnose AF in these patients.
We propose a study in which CS patients will be randomised in a 1:1 ratio to receive additional AW monitoring on top of standard care versus standard care alone. We shall then explore the incidence of AF in the two groups at 1 year and how it impacts on clinical outcomes too.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
21/WM/0230
Date of REC Opinion
10 Nov 2021
REC opinion
Further Information Favourable Opinion