Evaluation of the Effectiveness and Safety of Remote Electrocardiographic Monitoring in Patients with Atrial Fibrillation Following Ablation Therapy (PREEMPT-AF)

December 26, 2024 updated by: HUINNO Co., Ltd

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
        • Contact:
      • Busan, Korea, Republic of, 49241
        • Busan National University Hospital
        • Contact:
      • Seongnam, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
        • Contact:
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
        • Contact:
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
        • Contact:
      • Seoul, Korea, Republic of, 07804
        • Ewha Womans University Seoul Hospital
        • Contact:
      • Seoul, Korea, Republic of, 02855
        • Korea University Anam Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group

Participants in this clinical trial will undergo a total of three remote electrocardiographic (ECG) monitoring sessions during the study period following catheter ablation:

  1. st Monitoring: At the time of discharge after catheter ablation, remote ECG monitoring will be performed for 14 days using both the MEMO Patch 2 and MEMO Link.
  2. nd Monitoring: Approximately three months after catheter ablation, remote ECG monitoring will be performed for 14 days using only the MEMO Patch 2.
  3. rd Monitoring: Approximately one year after catheter ablation, remote ECG monitoring will again be performed for 14 days using only the MEMO Patch 2.
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.
Active Comparator: Active Comparator Group

Participants in this clinical trial will undergo a total of three remote electrocardiographic (ECG) monitoring sessions during the study period following catheter ablation:

  1. st Monitoring: At the time of discharge after catheter ablation, remote ECG monitoring will be conducted for 14 days using both the MEMO Patch 2 and MEMO Link.
  2. nd Monitoring: Approximately three months after catheter ablation, remote ECG monitoring will be conducted for 1 day using only the MEMO Patch 2.
  3. rd Monitoring: Approximately one year after catheter ablation, remote ECG monitoring will be conducted for 14 days using only the MEMO Patch 2.
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 Link
A supplementary ECG monitoring device used alongside MEMO Patch 2 during the 1st monitoring session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months post-ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months post-ablation
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.
12 months post-ablation
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.
12 months post-ablation
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.
3 months post-ablation
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.
12 months post-ablation
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.
12 months post-ablation
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.
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)
Proportion of participants with atrial tachyarrhythmias detected using daily ECG monitoring reports during the first monitoring phase (up to 30 days post-ablation).
30 days post-ablation (first monitoring phase)
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.
During all monitoring periods (up to 12 months post-ablation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HUINNO Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 6, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 26, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREEMPT-AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data, including basic demographic data and primary research outcome data, will be shared. These data will specifically pertain to research conducted on remote monitoring and atrial fibrillation. The shared data will not contain any personal identifiers to ensure participant

When the data are made available, a direct link to the external repository hosting the IPD will be provided in the References module of the Protocol Section on ClinicalTrials.gov.

IPD Sharing Access Criteria

Qualified researchers may request access to the IPD by submitting a formal application. Requests must include a detailed research proposal and evidence of ethical approval. All requests will be reviewed by an independent committee to ensure appropriate and ethical use of the data. Once a suitable data-sharing platform or repository is designated, detailed instructions for access will be provided in the ClinicalTrials.gov record.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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