Background:
Atrial fibrillation (AF) is the most common arrhythmia, significantly contributing to complications such as stroke, heart failure, dementia, and increased mortality. Catheter ablation is widely used for treatment, but recurrence rates range from 15-50% within 12 months post-procedure. Conventional intermittent ECG monitoring lacks sufficient sensitivity to detect asymptomatic AF recurrence effectively.
Objective:
To compare the recurrence rates of atrial tachyarrhythmias between a 1-day monitoring group and a 14-day monitoring group using MEMO Patch 2 after catheter ablation in AF patients. The study also evaluates the effectiveness and safety of early recurrence detection via remote monitoring.
Study Population:
Patients diagnosed with AF and treated with catheter ablation.
Intervention:
Participants will undergo three sessions of remote ECG monitoring using MEMO Patch 2 and MEMO Link (first session only), spanning approximately one year after catheter ablation.
Hypothesis:
Long-term monitoring with MEMO Patch 2 will be more effective than 1-day monitoring in detecting the recurrence of atrial tachyarrhythmias (including AF, atrial flutter, and atrial tachycardia) following catheter ablation.
1. Adults aged 19 years or older who have voluntarily provided written informed consent to participate in this clinical trial.
1. Individuals with a history of catheter ablation prior to obtaining informed consent.
Parallel
MEMO Patch 2 - 14-day Monitoring
DeviceA wearable ECG monitoring device used for continuous 14-day monitoring to detect atrial arrhythmias during the second monitoring phase (at 3 months post-ablation). MEMO Patch 2 collects ECG data for remote analysis to assess early recurrence of atrial arrhythmias.
MEMO Patch 2 - 1-day Monitoring
DeviceA wearable ECG monitoring device used for 1-day monitoring during the second monitoring phase (at 3 months post-ablation). MEMO Patch 2 collects ECG data for remote analysis to detect early recurrence of atrial arrhythmias.
MEMO Link
DeviceA supplementary ECG monitoring device used alongside MEMO Patch 2 during the 1st monitoring session.
Recurrence rate of atrial tachyarrhythmias 3 months post-catheter ablation
The proportion of participants with atrial tachyarrhythmias (including atrial fibrillation, atrial flutter, or atrial tachycardia lasting 30 seconds or more) detected during ECG monitoring at 3 months after catheter ablation using the MEMO Patch 2. The primary measure focuses on comparing the detection rate between the 14-day monitoring group and the 1-day monitoring group.
Risk Factors for Early and Late Recurrence of Atrial Tachyarrhythmias
Identification of clinical risk factors associated with early recurrence (within 3 months) and late recurrence (beyond 3 months) of atrial tachyarrhythmias following catheter ablation, using data collected through MEMO Patch 2 monitoring.
Rate of Medical Interventions Following Catheter Ablation
Proportion of participants requiring additional medical interventions such as anti-arrhythmic drug cessation, repeat ablation procedures, or unplanned clinical visits post-ablation.
Recurrence Rate of Atrial Tachyarrhythmias at 12 Months
Proportion of participants experiencing atrial tachyarrhythmias (lasting 30 seconds or more) detected by MEMO Patch 2 within 12 months after catheter ablation.
Early Recurrence Rate of Atrial Tachyarrhythmias
Proportion of participants with atrial tachyarrhythmias detected within 3 months post-ablation using MEMO Patch 2.
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