Clinical Implications of Atrial Fibrillation Detection Using Wearable Devices in Patients With Cryptogenic Stroke (CANDLE-AF) Trial: Design and Rationale

Abstract

BackgroundAlthough many electrocardiography wearable devices have been released recently for the detection of atrial fibrillation (AF), there are few studies reporting prospective data for wearable devices compared to the strategy of the existing guidelines in the detection of atrial fibrillation (AF) after cryptogenic stroke. A tiny single-patch monitor is more convenient than a conventional Holter monitor recording device and, therefore, longer duration of monitoring may be acceptable.Methods and DesignThe CANDLE-AF study is a multicenter, prospective, randomized controlled trial. Patients with transient ischemic attack or ischemic stroke without any history of AF will be enrolled. The superiority of the 72-h single-patch monitor to standard strategy and non-inferiority of the 72-h single-patch monitor to an event-recorder-type device will be investigated. Single-patch monitor arm will repeat monitoring at 1, 3, 6, and 12 months, event-recorder-type arm will repeat monitoring twice daily for 12 months. The enrollment goal is a total of 600 patients, and the primary outcome is the detection of AF which continues at least 30 s during study period. The secondary outcome is the rate of changes from antiplatelet to anticoagulant and major adverse cardiac and cerebrovascular events within 1 year.ConclusionsThe results of CANDLE-AF will clarify the role of a single-lead patch ECG for the early detection of AF in patients with acute ischemic stroke. In addition, the secondary outcome will be analyzed to determine whether more sensitive AF detection can affect the prognosis and if further device development is meaningful. (cris.nih.go.kr KCT0005592).

Quantitative Analysis Using Consecutive Time Window for Unobtrusive Atrial Fibrillation Detection Based on Ballistocardiogram Signal

“…Current technologies employed in wearables and evaluated for AF detection are most often based on single-lead ECG or PPG. For ECG-based AF detection, wearable devices include smartwatches/bands [ 43 , 44 ], smartphones [ 45 , 46 , 47 ], skin patch recorders [ 45 ], hand-held devices [ 46 , 47 ], and smart clothing [ 48 ]. These monitoring devices are convenient, but they are based on cardiac electrophysiology and lack the analysis of cardio-dynamic changes.…”

“…Compared with the techniques using wearable devices, BCG-based AF detection does not introduce an addition burden. For example, some devices demand individuals to place their fingers on the electrodes of a smartphone [ 46 , 47 ]. Moreover, the AF prevalence increases with age, especially for those aged > 65 years, whereas only 4.6% of smartwatch users in the United States are aged > 65 years [ 56 ].…”

Letter by Kim et al Regarding Article, “Detection of Atrial Fibrillation in a Large Population Using Wearable Devices: The Fitbit Heart Study”

“…Studies have shown that wearable devices are generally well tolerated and have comparable rates of atrial fibrillation detection in this important cohort. 5 This novel technology has the potential to improve community diagnostics of paroxysmal arrhythmias. There are multiple areas of implementation that still require validation; however, this research provides robust data, and we commend the authors.…”

Searching for atrial fibrillation post stroke: is it time for digital devices?

“…External monitoring is sometimes proposed before ILR. The randomized CANDLE-AF study will evaluate a 72-h single-patch monitor to standard strategy and to an event-recorder-type device in 600 IS patients without any history of AF ( 43 ). Single-patch monitor arm will repeat monitoring at 1, 3, 6, and 12 months, event-recorder-type arm will repeat monitoring twice daily for 12 months.…”