ICT-based Monitoring for Arrhythmia Detection After AF Ablation

Study Overview
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Brief Summary
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To compare the efficacy and stability of an ICT-based centralized clinical trial monitoring system against the efficacy and stability of an existing outpatient-based electrocardiogram (ECG) and Holter monitoring system for arrhythmia detection after atrial fibrillation ablation, and to test whether such continuous monitoring can better detect arrhythmia that is undetectable by existing methods and how this may affect treatment outcomes

Detailed Description
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This clinical trial is a prospective, randomized, controlled, multicenter study in patients who are capable of using and consent to use a smartphone-based ECG monitoring after ablation for atrial fibrillation. The patients will be randomly assigned to either the Holter monitoring or ICT-based centralized clinical trial monitoring system group in a 1:1 ratio and will undergo monitoring from immediately after the procedure to 12 months after discharge.

Official Title
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Efficacy and Stability of an Information and Communication Technology (ICT)-Based Centralized Monitoring System for Arrhythmia Detection After Atrial Fibrillation Ablation: a Prospective, Randomized Controlled, Multicenter Study

Conditions
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Arrhythmias, Cardiac, Atrial Fibrillation

Intervention / Treatment
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* Device: ICT-based ECG monitoring
* Device: Holter monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 20 years, but < 80 years Patients with non-valvular atrial fibrillation Patients with sustained atrial fibrillation despite ≥ 6 weeks of continuous antiarrhythmia therapy or those who underwent an ablation procedure for tachy-bradycardia syndrome within the previous week Patients who can be followed-up for at least 3 months after ablation Patients who can use and consent to use smartphone-based ECG monitoring Patients who can use a smartphone (Android, version 5.0 or lower; development planned for version 6.0 or higher) Those who can connect to the internet via LAN or WiFi and are in an environment where they can use a gateway and smartphone. Exclusion Criteria: Patients who cannot be monitored by a smartphone or Bluetooth device Patients who cannot use a smartphone, Bluetooth device, or the internet due to old age Patients with contraindications to standard therapy, such as continued anticoagulant therapy before and after atrial fibrillation ablation Patients belonging to a population vulnerable to clinical trials

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICT-based ECG monitoring group<br>Continuous monitoring with ICT-based ECG monitoring will begin from the time of participation in the trial in the ICT-based monitoring group. Depending on the lifestyle pattern of the patient, the specific time will be set to allow 30 min of monitoring per day, even if there are no symptoms. If symptoms do appear, additional monitoring will be performed for at least 10 more minutes. 24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups in this group, as in the Holter monitoring group. | Device: ICT-based ECG monitoring<br>* Continuous monitoring will begin from the time of participation in the trial in the ICT-based centralized monitoring group. 24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups in this group, as in the Holter monitoring group. If heart rate drops below 40 beats/min or increases above 120 beats/min on ECG during ICT-based ECG home monitoring, the participant will be notified first through an alarm function.<br>|
| Active Comparator: Holter monitoring group<br>24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups in the Holter monitoring group | Device: Holter monitoring<br>* 24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in arrhythmia detection rate | The difference in arrhythmia detection rate between Holter monitoring and ICT-based centralized monitoring | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the number of hospital visits | The difference in the number of hospital visits during the study period due to arrhythmia | 12 months | 
| The difference in the recurrence rate of atrial fibrillation or atrial tachycardia | The difference in the recurrence rate of atrial fibrillation or atrial tachycardia within 1 year from atrial fibrillation ablation | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arrhythmias, Atrial Fibrillation