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

NCT06751459 | Not Yet Recruiting

• 1 other identifier: PREEMPT-AF
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 7

Brief 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)

Keywords

Atrial fibrillation; circulatory system; EKG; remote monitoring; gateway; MEMO-Patch

Outcome Measures

Primary Outcomes (1)

• Recurrence rate of atrial tachyarrhythmias 3 months post-catheter 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 Outcomes (9)

• Risk Factors for Early and Late Recurrence of Atrial Tachyarrhythmias

  12 months post-ablation

• Rate of Medical Interventions Following Catheter Ablation

  12 months post-ablation

• Recurrence Rate of Atrial Tachyarrhythmias at 12 Months

  12 months post-ablation

• Early Recurrence Rate of Atrial Tachyarrhythmias

  3 months post-ablation

• Detection Rate of Non-Atrial Tachyarrhythmias Using MEMO Patch 2

  12 months post-ablation

Study Arms (2)

Experimental Group

EXPERIMENTAL

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; Device: MEMO Link

Active Comparator Group

ACTIVE COMPARATOR

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; Device: MEMO Link

Interventions

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.

Active Comparator Group

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.

Experimental Group

MEMO Link DEVICE

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

Active Comparator Group; Experimental Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• HUINNO Co., Ltd: lead

Study Sites (7)

Dong-A University Hospital

Busan, 49201, South Korea

Location

Busan National University Hospital

Busan, 49241, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Korea University Anam Hospital

Seoul, 02855, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Ewha Womans University Seoul Hospital

Seoul, 07804, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jong-il Choi

CONTACT

+821021225476; stabler92@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

KR (7)