Evaluation of the Effectiveness and Safety of Remote Electrocardiographic Monitoring in Patients with Atrial Fibrillation Following Ablation Therapy
NCT ID: NCT06751459
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
270 participants
INTERVENTIONAL
2025-01-06
2027-03-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
MEMO Link
A supplementary ECG monitoring device used alongside MEMO Patch 2 during the 1st monitoring session.
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.
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.
MEMO Link
A supplementary ECG monitoring device used alongside MEMO Patch 2 during the 1st monitoring session.
Interventions
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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.
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.
MEMO Link
A supplementary ECG monitoring device used alongside MEMO Patch 2 during the 1st monitoring session.
Eligibility Criteria
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Inclusion Criteria
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
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.
19 Years
ALL
No
Sponsors
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HUINNO Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Dong-A University Hospital
Busan, , South Korea
Busan National University Hospital
Busan, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Ewha Womans University Seoul Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jongseong Park
Role: primary
Jinhee An
Role: primary
Ilyoung Oh
Role: primary
Jongil Choi
Role: primary
Gibyung Nam
Role: primary
Donghyuk Kim
Role: primary
Seungyoung Ro
Role: primary
Other Identifiers
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PREEMPT-AF
Identifier Type: -
Identifier Source: org_study_id