NCT06751459

Evaluation of the Effectiveness and Safety of Remote Electrocardiographic Monitoring in Patients with Atrial Fibrillation Following Ablation Therapy

Patch ECG-based REcurrEnce Monitoring After Catheter Ablation in PaTients with Atrial Fibrillation (PREEMPT-AF) : a Multicenter, Randomized Controlled, Open-label, Prospective Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: HUINNO Co., Ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
DEVICE	MEMO Patch 2 - 14-day Monitoring	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.
DEVICE	MEMO Patch 2 - 1-day Monitoring	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.
DEVICE	MEMO Link	A supplementary ECG monitoring device used alongside MEMO Patch 2 during the 1st monitoring session.

Timeline

• Start date: 2025-01-06
• Primary completion: 2026-08-01
• Completion: 2027-03-01
• First posted: 2024-12-27
• Last updated: 2024-12-31

Locations

7 sites across 1 country: South Korea