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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство MEMO Link
  A supplementary ECG monitoring device used alongside MEMO Patch 2 during the 1st monitoring session.

Первичные конечные точки

• Recurrence rate of atrial tachyarrhythmias 3 months post-catheter ablation [Срок оценки: 3 months post-ablation]

Вторичные конечные точки (9)

• Risk Factors for Early and Late Recurrence of Atrial Tachyarrhythmias [Срок оценки: 12 months post-ablation]
• Rate of Medical Interventions Following Catheter Ablation [Срок оценки: 12 months post-ablation]
• Recurrence Rate of Atrial Tachyarrhythmias at 12 Months [Срок оценки: 12 months post-ablation]
• Early Recurrence Rate of Atrial Tachyarrhythmias [Срок оценки: 3 months post-ablation]
• Detection Rate of Non-Atrial Tachyarrhythmias Using MEMO Patch 2 [Срок оценки: 12 months post-ablation]
• Time to First Recurrence of Atrial Tachyarrhythmias [Срок оценки: 12 months post-ablation]
• ECG Signal Transmission Success Rate Using MEMO Link [Срок оценки: During all monitoring periods (up to 12 months post-ablation)]
• Detection Rate of Atrial Tachyarrhythmias in Daily Monitoring Reports [Срок оценки: 30 days post-ablation (first monitoring phase)]
• Device-Related Adverse Events [Срок оценки: During all monitoring periods (up to 12 months post-ablation)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

South Korea · 7 центров

• 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

Идентификаторы

NCT: NCT06751459 · PREEMPT-AF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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