AFFU-AW study
Research type
Research Study
Full title
Evaluating the impact of prolonged, patient-led heart rhythm surveillance with the Apple Watch for detecting arrhythmia recurrence and decision-making after catheter ablation of atrial fibrillation.
IRAS ID
292605
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, 0 days
Research summary
Atrial fibrillation (AF) is a heart rhythm disorder associated with debilitating symptoms, psychological distress and heart failure. It can also significantly increase an individual's stroke risk. Catheter ablation (CA) for AF is the most effective way to restore normal heart rhythm. However, AF can recur in up to 50% of patients after their first AFCA procedure and a second 'top-up' procedure may be needed to maximise treatment effect. Early detection of AF recurrences can enable planning and consideration of repeat AFCA procedures.
Post-AFCA follow-up strategies rely on episodic rhythm monitoring; a 10-second ECG or Holter monitor tests that usually last between 1 and 7 days. However, AF recurrences can be intermittent and may be missed by these short monitoring periods. A greater duration of monitoring has been shown to yield greater detection of AF recurrence.
Other rhythm disturbances can also occur after AFCA causing similar symptoms. These may require different management approaches, necessitating rhythm recording before considering any repeat treatment.
The Apple Watch (AW) is a wristwatch that is able to monitor a wearer’s heart rate and rhythm regularity as well as facilitating immediate, real-time, single-lead ECG recording. This non-invasive device that can be purchased over-the-counter, has demonstrated feasibility in detecting AF and may offer be a potential non-invasive, alternative long-term rhythm surveillance strategy to diagnose AF recurrences in these patients.
We propose a single-centre, randomised controlled study to compare the standard follow-up strategy after index AFCA versus one supplemented with an AW-led prolonged monitoring strategy to determine if the latter will improve the expediency and rate of AF recurrence detection. Whether this will lead to improved downstream decision-making, reduction in symptomatic events and a lower prevalence of AF in the longer term will also be studied.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
21/WM/0228
Date of REC Opinion
10 Nov 2021
REC opinion
Further Information Favourable Opinion