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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac
• Intervention / Treatment: Device: ICT-based ECG monitoring; Device: Holter monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyoung-Seob Park, MD; Phone Number: +82-53-250-7314; Email: drparkgyver@gmail.com
• Study Contact Backup: Name: Kyung-Min Lee; Phone Number: +82-53-250-7314; Email: kyungmin2@dsmc.or.kr

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700-712
    • Keimyung University Dongsan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICT-based ECG monitoring group; 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; 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.
Active Comparator: Holter monitoring group; 24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups in the Holter monitoring group	Device: Holter monitoring; 24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center
• Collaborators: Ministry of Trade, Industry & Energy, Republic of Korea; Korea Evaluation Institute of Industrial Technology; Daegu Metropolitan City, Korea; ICT Clinical Trial Coordination Center
• Investigators: Principal Investigator: Hyoung-Seob Park, MD, Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 20, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Arrhythmias, Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: ICT_CM_P03_AF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No