Personalized approach using wearable technology for early detection of Atrial Fibrillation (PATCH-AF)

Atrial fibrillation (AF) is a cardiac arrhythmia with a lifetime risk of
approximately one in four. The presence of AF strongly increases one person*s
risk of stroke and, heart failure. There is furthermore growing evidence that
AF is an independent risk factor for cognitive decline and dementia. Currently,
one in five strokes is related to undetected AF. Approximately 60% of these
strokes could have been prevented if AF would have been detected earlier and
prophylactic anticoagulant therapy would have been started. However, in daily
practice detecting AF can be quite challenging, as it often occurs in a
paroxysmal form, meaning that many cases are left undiagnosed and thereby
exposed to stroke when only using a single time-point assessment. Fortunately,
due to advances in technology, we are now able to increase the chance of
detecting paroxysmal AF with patient-friendly, non-obtrusive cardiac monitoring
devices that allow for continuous arrhythmia detection for up to 7 days. This
sets the stage for a program that targets individuals at high risk for AF for
selective screening with this new technology. Epidemiological studies show that
mostly patients aged 65 and older are at high risk of developing AF. Moreover
clinical risk scores have been developed that can further risk-stratify
individuals. The CHA2DS2-VASc score, developed to determine initiation of
anticoagulant therapy in patients with AF, also has the ability to predict the
risk of AF and appears most favorable due to its ease-of-use and compatibility
with electronic health records. We therefore aim to evaluate the diagnostic
yield for AF when using continuous cardiac monitoring in older patients deemed
at high risk (based on CHA2DS2-VASc) compared with routine practice.

The primary objective will be evaluating the difference in detection of new AF
between the intervention practices (yearly 7 days AF screening with continuous
heart rhythm monitoring) and control practices (care as usual) over three years
of follow-up.

General practice based, network-run, cluster-randomized controlled trial (RCT)
with randomization at the practice level. The network concerns the *Academisch
Huisartsennetwerk AMC*, which includes data from almost a half million patients
in the Amsterdam region. The network database is fed with information that is
received quarterly via automated data extractions from the affiliated general
practices. Study duration is three years.

7-day ECG- monitoring using the Bittium Faros 360 at baseline (t=0), after
one(t=1) and two years (t=2).

A burden for participants consists of wearing the 7 day ECG monitor.The main
side-effect of the ECG monitor could be a local skin allergy requiring to
remove the monitor and end the intervention. No other health risks are involved
for participants. Patients might benefit in an early diagnosis of atrial
fibrillation and hereby early treatment leading to a reduced risk of
complications such as ischemic stroke. Furthermore participants will fill out a
questionnaire after the first and third screenings round.