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ClinicalTrials.gov ID

NCT06751459

Lead Sponsor

HUINNO Co., LtdINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

270Estimated

Last Update Posted

Dec 31, 2024Actual

Start Date

Jan 6, 2025Estimated

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Mar 1, 2027Estimated

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

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.

• Atrial Fibrillation (AF)

• MEMO Patch 2 - 14-day Monitoring
• MEMO Patch 2 - 1-day Monitoring
• MEMO Link

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

HUINNO Co., LtdINDUSTRY

reinee81@naver.com+82-51-240-7794

jongilchoi@korea.ac.kr+82-10-2122-5476

gbnam@amc.seoul.kr+82-10-3127-5681

tomas9912@naver.com+82-10-2724-7740

rsy008@gmail.com+82-10-3612-6876