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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
270
A 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.
A 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.
A supplementary ECG monitoring device used alongside MEMO Patch 2 during the 1st monitoring session.
Dong-A University Hospital
Busan, South Korea
Busan National University Hospital
Busan, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Korea University Anam Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Ewha Womans University Seoul Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
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.
Time frame: 3 months post-ablation
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.
Time frame: 12 months post-ablation
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.
Time frame: 12 months 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.
Time frame: 12 months post-ablation
Early Recurrence Rate of Atrial Tachyarrhythmias
Proportion of participants with atrial tachyarrhythmias detected within 3 months post-ablation using MEMO Patch 2.
Time frame: 3 months post-ablation
Detection Rate of Non-Atrial Tachyarrhythmias Using MEMO Patch 2
Proportion of participants with non-atrial tachyarrhythmias, such as ventricular premature contractions or supraventricular tachycardia, detected during MEMO Patch 2 monitoring.
Time frame: 12 months post-ablation
Time to First Recurrence of Atrial Tachyarrhythmias
The time interval from catheter ablation to the first detection of atrial tachyarrhythmias lasting 30 seconds or more during MEMO Patch 2 monitoring.
Time frame: 12 months post-ablation
ECG Signal Transmission Success Rate Using MEMO Link
Percentage of successfully transmitted ECG signals during the monitoring period using the MEMO Link device.
Time frame: During all monitoring periods (up to 12 months post-ablation)
Detection Rate of Atrial Tachyarrhythmias in Daily Monitoring Reports
Proportion of participants with atrial tachyarrhythmias detected using daily ECG monitoring reports during the first monitoring phase (up to 30 days post-ablation).
Time frame: 30 days post-ablation (first monitoring phase)
Device-Related Adverse Events
Rate of adverse events potentially related to the use of MEMO Patch 2 or MEMO Link during the study period, assessed through investigator reports.
Time frame: During all monitoring periods (up to 12 months post-ablation)
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