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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010129

Enrollment

270

Registered

2025-01-10

Start date

2025-05-20

Completion date

Unknown

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Participants in this clinical trial will undergo a total of three remote electrocardiographic (ECG) monitoring sessions during the study period following catheter ablation: 1st Monit

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Recurrence rate of atrial tachyarrhythmias 3 months post-catheter ablation	—

Secondary

Measure	Time frame
Assessment of risk factors for early and late recurrence of atrial tachyarrhythmias;Need for medical intervention after catheter ablation;Recurrence rate of atrial tachyarrhythmias 12 months post-catheter ablation;Early recurrence rate of atrial tachyarrhythmias;Detection rate of arrhythmias excluding atrial tachyarrhythmias during MEMO Patch 2 monitoring;Date of first occurrence of atrial tachyarrhythmias during the MEMO Patch 2 monitoring period;Transmission rate of electrocardiographic signals via MEMO Link;Early detection rate of atrial tachyarrhythmias through daily monitoring reports;Adverse events suspected to be related to the investigational medical device	—

Measure

Time frame

Assessment of risk factors for early and late recurrence of atrial tachyarrhythmias;Need for medical intervention after catheter ablation;Recurrence rate of atrial tachyarrhythmias 12 months post-catheter ablation;Early recurrence rate of atrial tachyarrhythmias;Detection rate of arrhythmias excluding atrial tachyarrhythmias during MEMO Patch 2 monitoring;Date of first occurrence of atrial tachyarrhythmias during the MEMO Patch 2 monitoring period;Transmission rate of electrocardiographic signals via MEMO Link;Early detection rate of atrial tachyarrhythmias through daily monitoring reports;Adverse events suspected to be related to the investigational medical device

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Countries

Korea, Republic of

Contacts

Public ContactKim Yu-ri

Korea University Anam Hospital

igysa@korea.ac.kr+82-2-920-6710

Outcome results