Improving AF Detection in Cryptogenic Stroke — CSAF-AW  

Atrial Fibrillation Clinical Trial

Official title: A Non-invasive, Prolonged Surveillance Strategy Using Apple Watch for Atrial Fibrillation Detection in Cryptogenic Stroke

Status Recruiting

Clinical Trial 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 whereas this standard monitoring strategy picks up AF in 2% of CS patients, longer-term, continuous monitoring for 12 months 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. Prolonged 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 Certification (CE) Mark for detecting AF. It may offer a potential non-invasive alternative long-term rhythm surveillance strategy to diagnose AF in these patients. The investigators 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. The investigators shall then explore the incidence of AF in the two groups at 1 year and how it impacts clinical outcomes too.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cryptogenic Stroke
• Ischemic Stroke
• Stroke

• NCT number: NCT05007847
• Study type: Interventional
• Source: Barts & The London NHS Trust
• Contact: Richard Schilling
• Phone: 02037658635
• Email: richard.schilling@nhs.net
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2022
• Completion date: December 2025