NCT03256812

ICT-based Monitoring for Arrhythmia Detection After AF Ablation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Keimyung University Dongsan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Arrhythmias, Cardiac
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	ICT-based ECG monitoring	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.
DEVICE	Holter monitoring	24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-08-31
• Completion: 2018-12-31
• First posted: 2017-08-22
• Last updated: 2023-10-18

Locations

1 site across 1 country: South Korea