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

HUINNO Co., Ltd

Status: Not yet enrolling

Conditions: Atrial Fibrillation (AF)

Treatments: Device: MEMO Patch 2 - 14-day Monitoring; Device: MEMO Patch 2 - 1-day Monitoring; Device: MEMO Link

Study type: Interventional

Funder types: Industry

Identifiers

NCT06751459

PREEMPT-AF

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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.

Treatment:

Device: MEMO Link

Device: MEMO Patch 2 - 1-day Monitoring

Active Comparator Group

Active Comparator group

Description:

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.

Treatment:

Device: MEMO Link

Device: MEMO Patch 2 - 14-day Monitoring