Procedures
burn injuries, cutaneous pruritus
ADVERSE REACTIONS, EVENTS, EVENT
After catheter ablation, patients provided informed consent to participate in this study. Those who met the inclusion criteria and did not meet the exclusion criteria were enrolled and randomly allocated to one of the two groups. Three months after catheter ablation, patients started ECG monitoring using the device that had been allocated to their group at randomization (2 weeks using the hitoe Medical Electrode II (Toray Medical Co., Ltd., Tokyo, Japan) with the hitoe ECG Recorder EV-301(Parama-Tech Co., Ltd., Fukuoka, Japan) and hitoe Medical Leads II (Toray Medical Co., Ltd., Tokyo, Japan) in the Garment ECG group or the disposable electrode NC-105CM (NIHON KOHDEN CORPORATION, Tokyo, Japan) with Long-term Recorder RAC-3103 (NIHON KOHDEN CORPORATION, Tokyo, Japan) and Patient Cables BJ-322D (NIHON KOHDEN CORPORATION, Tokyo, Japan) in the Holter group. At the end of the first time period, each patient was switched to the other device. The total for the two time periods was 15 days. Study staff reviewed all adverse reactions and undesirable events for each ECG device, and the patients completed questionnaires when they returned the last allocated ECG device. The ECG data were analyzed automatically using ECG analyzers: NEY-HEA3000 (Nexis Co., Ltd., Fukuoka, Japan) for the Garment ECG group and DSC-3300 (NIHON KOHDEN CORPORATION, Tokyo, Japan) for the Holter group. The results were entered into each patient’s electronic medical record. Patients were required to remove the Garment ECG device when bathing to protect the electrode from water, and in the event of magnetic resonance imaging because local heating from induced electromotive force might cause burn injuries. Use of topical agents for cutaneous pruritus was permitted.Block randomization was processed, and a sequential number for ECG session was assigned automatically by a computer system, the UHCT ACReSS (University Hospital Clinical Trial Alliance Clinical Research Support System). Block size was ten, and the allocation ratio was equalized between the two groups. The allocation sequence was concealed through a third-party assignment implemented by the clinical research coordinators. Patients were enrolled by investigators other than the statistician.