Clinical trial NCT06751459: Evaluation of the Effectiveness and Safety of Remote Electrocardiographic Monitoring in Patients with Atrial Fibrillation Following Ablation Therapy
Official title: Patch ECG-based REcurrEnce Monitoring After Catheter Ablation in PaTients with Atrial Fibrillation (PREEMPT-AF) : a Multicenter, Randomized Controlled, Open-label, Prospective Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Keywords: Atrial fibrillation
circulatory system
EKG
remote monitoring
gateway
MEMO-Patch
Lead sponsor: HUINNO Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-12-27
Enrollment: 270
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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:

* 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.

Primary outcomes:
measure: Recurrence rate of atrial tachyarrhythmias 3 months post-catheter ablation
timeFrame: 3 months post-ablation
Secondary outcomes:
measure: Risk Factors for Early and Late Recurrence of Atrial Tachyarrhythmias
timeFrame: 12 months post-ablation
measure: Rate of Medical Interventions Following Catheter Ablation
timeFrame: 12 months post-ablation
measure: Recurrence Rate of Atrial Tachyarrhythmias at 12 Months
timeFrame: 12 months post-ablation
measure: Early Recurrence Rate of Atrial Tachyarrhythmias
timeFrame: 3 months post-ablation
measure: Detection Rate of Non-Atrial Tachyarrhythmias Using MEMO Patch 2
timeFrame: 12 months post-ablation
measure: Time to First Recurrence of Atrial Tachyarrhythmias
timeFrame: 12 months post-ablation
measure: ECG Signal Transmission Success Rate Using MEMO Link
timeFrame: During all monitoring periods (up to 12 months post-ablation)
measure: Detection Rate of Atrial Tachyarrhythmias in Daily Monitoring Reports
timeFrame: 30 days post-ablation (first monitoring phase)
measure: Device-Related Adverse Events
timeFrame: During all monitoring periods (up to 12 months post-ablation)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Busan National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References: