ICT-based Monitoring for Arrhythmia Detection After AF Ablation

Keimyung University Dongsan Medical Center50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Arrhythmias, Cardiac Atrial Fibrillation

Interventions

ICT-based ECG monitoringDEVICE

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.

Holter monitoringDEVICE

24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 20 years, but \< 80 years 2. Patients with non-valvular atrial fibrillation 3. 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 4. Patients who can be followed-up for at least 3 months after ablation 5. Patients who can use and consent to use smartphone-based ECG monitoring 6. Patients who can use a smartphone (Android, version 5.0 or lower; development planned for version 6.0 or higher) 7. 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: 1. Patients who cannot be monitored by a smartphone or Bluetooth device 2. Patients who cannot use a smartphone, Bluetooth device, or the internet due to old age 3. Patients with contraindications to standard therapy, such as continued anticoagulant therapy before and after atrial fibrillation ablation 4. Patients belonging to a population vulnerable to clinical trials

Locations (1)

Keimyung University Dongsan Medical Center

Daegu, South Korea

Outcomes

Primary Outcomes

The difference in arrhythmia detection rate

The difference in arrhythmia detection rate between Holter monitoring and ICT-based centralized monitoring

Time frame: 12 months

Secondary Outcomes

The difference in the number of hospital visits

The difference in the number of hospital visits during the study period due to arrhythmia

Time frame: 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

Time frame: 12 months

Data from ClinicalTrials.gov

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