Endpoints
redness, erosion, non-AF arrythmia
EROSION, RECURRENCE, SECONDARY, FLUTTER, SCARRING, EVENTS
The primary endpoint was the detection rate of patients with AF recurrence. AF recurrence was defined as AF or arterial flutter lasting 30 seconds or longer, a definition that is widely used for assessing AF after catheter ablation [The major secondary endpoint was the ECG acquisition rate, which was defined as the ratio of “time for analysis (recording time − noise)” to total recording time. Recording time was defined as monitoring time minus the time for which monitoring was not possible because the patient had removed the garment for bathing, etc. Device comfort while wearing was assessed by questionnaire, and incidence of non-AF arrythmia events was also assessed.Safety endpoints were presence of redness, erosion, or scarring. Before removing the investigational device, a clinical laboratory technologist and a clinical research coordinator reviewed the questionnaire and observed the site where the device was attached. If any injury to the skin was suspected, the site was examined by a physician.