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

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT06751459
• Lead Sponsor: HUINNO Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-26
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-31
• Study Start: 2025-01-06
• Primary Completion: 2026-08-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence rate of atrial tachyarrhythmias 3 months post-catheter ablation	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 Outcome Measures

Name	Time	Method
Risk Factors for Early and Late Recurrence of Atrial Tachyarrhythmias	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.
Rate of Medical Interventions Following Catheter Ablation	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.
Recurrence Rate of Atrial Tachyarrhythmias at 12 Months	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.
Early Recurrence Rate of Atrial Tachyarrhythmias	3 months post-ablation	Proportion of participants with atrial tachyarrhythmias detected within 3 months post-ablation using MEMO Patch 2.
Detection Rate of Non-Atrial Tachyarrhythmias Using MEMO Patch 2	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.
Time to First Recurrence of Atrial Tachyarrhythmias	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.
ECG Signal Transmission Success Rate Using MEMO Link	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.
Detection Rate of Atrial Tachyarrhythmias in Daily Monitoring Reports	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).
Device-Related Adverse Events	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.

Trial Locations

Locations (7)

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Busan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Ewha Womans University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of