Remote heart rhythm patch monitoring after ablation for atrial fibrillation
Tests a remote heart rhythm patch to detect atrial fibrillation return after ablation in adults.
Plain-language title generated from the registry record
Registry title: Evaluation of the Effectiveness and Safety of Remote Electrocardiographic Monitoring in Patients with Atrial Fibrillation Following Ablation Therapy
Key facts
- Where
- Busan, Seongnam, and Seoul, South KoreaSee the 7 sites
Where in South Korea
- Busan National University HospitalBusan, South KoreaNo longer taking part
- Dong-A University HospitalBusan, South KoreaNo longer taking part
- Seoul National University Bundang HospitalSeongnam, South KoreaNo longer taking part
- Asan Medical CenterSeoul, South KoreaNo longer taking part
- Ewha Womans University Seoul HospitalSeoul, South KoreaNo longer taking part
- Korea University Anam HospitalSeoul, South KoreaNo longer taking part
- Korea University Guro HospitalSeoul, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- HUINNO Co., Ltd
- Trial code
- NCT06751459
- Record updated
- 31 December 2024
- Original description
Background:Read full original descriptionShow less
Patch ECG-based REcurrEnce Monitoring After Catheter Ablation in PaTients with Atrial Fibrillation (PREEMPT-AF) : a Multicenter, Randomized Controlled, Open-label, Prospective Trial
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.
Inclusion: 1. 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.
Exclusion: 1. 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.