Personalized approach using wearable technology for early detection of atrial fibrillation in high-risk primary care patients (PATCH-AF): Study protocol for a cluster randomized controlled trial

Atrial fibrillation (AF) is a common cardiac arrhythmia with a lifetime risk of one in 4. Unfortunately, AF often remains undetected, particularly when it is paroxysmal, for which single time-point evaluation is less effective. Recently, unobtrusive cardiac arrhythmia monitoring devices have become available, providing the opportunity to conduct prolonged electrocardiographic (ECG) monitoring in a patient-friendly manner. We hypothesize that applying these devices in at risk patients may improve AF detection, particularly when used during repeated episodes. We therefore aim to evaluate the diagnostic yield of yearly screening for atrial fibrillation when using a wearable device for continuous ECG monitoring for 7 days in primary care patients ≥ 65 years deemed at high-risk of AF (CHA2DS2VASc score ≥3 for men or ≥4 for women) compared with usual care over a study period of 3 years. Primary care based, cluster-randomized controlled trial with 10 general practices randomized to the intervention group and 10 general practices randomized to control group. In each group, we aim to enroll 930 patients, ≥65 years and a CHA2DS2VASc score ≥3 for men or ≥ 4 for women. The intervention consists of continuous ECG monitoring for 7 days at start of the study (t = 0), after one (t = 1) and 2 years (t = 2). The control practices will follow usual diagnostic care procedures. Results are expected in 2025. This study differs from previous randomized controlled trials, as it involves longitudinal screening of a risk-stratified population. In case of a beneficial diagnostic yield, the PATCH-AF study will add to the evidence for AF screening. The PATCH-AF study is registered at The Netherlands Trial Register (NTR number NL9656)