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NCT Number: NCT06751459

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

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Busan National University Hospital, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Adults aged 19 years or older who have voluntarily provided written informed consent to participate in this clinical trial.
  • Individuals who have been diagnosed with atrial fibrillation prior to the date of informed consent acquisition.
  • 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.
  • Individuals with sensitive skin, allergic skin conditions, skin cancer, rashes, or other dermatological disorders.
  • Individuals with implanted cardiac devices, such as pacemakers, implantable defibrillators, or other implantable electronic devices.
  • Individuals deemed by the investigator to be at an increased risk or otherwise unsuitable for participation in the clinical trial.
  • Individuals with cognitive impairments that make it difficult to understand trial information or voluntarily make an informed decision.
  • Pregnant or breastfeeding women.

Treatment and study plan

MEMO Patch 2 - 14-day Monitoring

Device

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.

MEMO Patch 2 - 1-day Monitoring

Device

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.

MEMO Link

Device

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

Primary outcomes

  1. Recurrence rate of atrial tachyarrhythmias 3 months post-catheter ablation

    Time frame: 3 months post-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.

Secondary outcomes

  1. Risk Factors for Early and Late Recurrence of Atrial Tachyarrhythmias

    Time frame: 12 months post-ablation

    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.

  2. Rate of Medical Interventions Following Catheter Ablation

    Time frame: 12 months post-ablation

    Proportion of participants requiring additional medical interventions such as anti-arrhythmic drug cessation, repeat ablation procedures, or unplanned clinical visits post-ablation.

  3. Recurrence Rate of Atrial Tachyarrhythmias at 12 Months

    Time frame: 12 months post-ablation

    Proportion of participants experiencing atrial tachyarrhythmias (lasting 30 seconds or more) detected by MEMO Patch 2 within 12 months after catheter ablation.

  4. Early Recurrence Rate of Atrial Tachyarrhythmias

    Time frame: 3 months post-ablation

    Proportion of participants with atrial tachyarrhythmias detected within 3 months post-ablation using MEMO Patch 2.

  5. Detection Rate of Non-Atrial Tachyarrhythmias Using MEMO Patch 2

    Time frame: 12 months post-ablation

    Proportion of participants with non-atrial tachyarrhythmias, such as ventricular premature contractions or supraventricular tachycardia, detected during MEMO Patch 2 monitoring.

  6. Time to First Recurrence of Atrial Tachyarrhythmias

    Time frame: 12 months post-ablation

    The time interval from catheter ablation to the first detection of atrial tachyarrhythmias lasting 30 seconds or more during MEMO Patch 2 monitoring.

  7. ECG Signal Transmission Success Rate Using MEMO Link

    Time frame: During all monitoring periods (up to 12 months post-ablation)

    Percentage of successfully transmitted ECG signals during the monitoring period using the MEMO Link device.

  8. Detection Rate of Atrial Tachyarrhythmias in Daily Monitoring Reports

    Time frame: 30 days post-ablation (first monitoring phase)

    Proportion of participants with atrial tachyarrhythmias detected using daily ECG monitoring reports during the first monitoring phase (up to 30 days post-ablation).

  9. Device-Related Adverse Events

    Time frame: During all monitoring periods (up to 12 months post-ablation)

    Rate of adverse events potentially related to the use of MEMO Patch 2 or MEMO Link during the study period, assessed through investigator reports.

Study contacts

Contact information is provided by the study sponsor or research team.

Jong-il Choi

CONTACT

[email protected]

+821021225476

Sponsors and collaborators

Lead sponsor

HUINNO Co., Ltd

Industry

Registry information

Official study title

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

Acronym: PREEMPT-AF

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 27, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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