Evaluation of the Effectiveness and Safety of Remote Electrocardiographic Monitoring in Patients with Atrial Fibrillation Following Ablation Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MEMO Patch 2 - 14-day Monitoring, MEMO Patch 2 - 1-day Monitoring, MEMO Link.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Patch ECG-based REcurrEnce Monitoring After Catheter Ablation in PaTients with Atrial Fibrillation (PREEMPT-AF) : a Multicenter, Randomized Controlled, Open-label, Prospective Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Recurrence rate of atrial tachyarrhythmias 3 months post-catheter ablation [Time frame: 3 months post-ablation]
Secondary outcome measures (9)
- Risk Factors for Early and Late Recurrence of Atrial Tachyarrhythmias [Time frame: 12 months post-ablation]
- Rate of Medical Interventions Following Catheter Ablation [Time frame: 12 months post-ablation]
- Recurrence Rate of Atrial Tachyarrhythmias at 12 Months [Time frame: 12 months post-ablation]
- Early Recurrence Rate of Atrial Tachyarrhythmias [Time frame: 3 months post-ablation]
- Detection Rate of Non-Atrial Tachyarrhythmias Using MEMO Patch 2 [Time frame: 12 months post-ablation]
- Time to First Recurrence of Atrial Tachyarrhythmias [Time frame: 12 months post-ablation]
- ECG Signal Transmission Success Rate Using MEMO Link [Time frame: During all monitoring periods (up to 12 months post-ablation)]
- Detection Rate of Atrial Tachyarrhythmias in Daily Monitoring Reports [Time frame: 30 days post-ablation (first monitoring phase)]
- Device-Related Adverse Events [Time frame: During all monitoring periods (up to 12 months post-ablation)]
Eligibility criteria
Inclusion criteria
- 1\. Adults aged 19 years or older who have voluntarily provided written informed consent to participate in this clinical trial.
2\. Individuals who have been diagnosed with atrial fibrillation prior to the date of informed consent acquisition.
3\. Individuals who are scheduled to undergo catheter ablation for atrial fibrillation within three months from the date of informed consent acquisition.
Exclusion criteria
- 1\. Individuals with a history of catheter ablation prior to obtaining informed consent.
2\. Individuals with sensitive skin, allergic skin conditions, skin cancer, rashes, or other dermatological disorders.
3\. Individuals with implanted cardiac devices, such as pacemakers, implantable defibrillators, or other implantable electronic devices.
4\. Individuals deemed by the investigator to be at an increased risk or otherwise unsuitable for participation in the clinical trial.
5\. Individuals with cognitive impairments that make it difficult to understand trial information or voluntarily make an informed decision.
6\. Pregnant or breastfeeding women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
South Korea · 7 centers
- Dong-A University Hospital — Busan
- Busan National University Hospital — Busan
- Seoul National University Bundang Hospital — Seongnam
- Korea University Anam Hospital — Seoul
- Asan Medical Center — Seoul
- Ewha Womans University Seoul Hospital — Seoul
- Korea University Guro Hospital — Seoul
Identifiers
NCT: NCT06751459 · PREEMPT-AF