ICT-based Monitoring for Arrhythmia Detection After AF Ablation

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac
• Interventions: Device: Holter monitoring; Device: ICT-based ECG monitoring

• Registration Number: NCT03256812
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief 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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-20
• Study First Posted: 2017-08-22
• Primary Completion: 2018-08-31
• Study Completion: 2018-12-31
• Status Verified: 2019-03
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Holter monitoring group	Holter monitoring	24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups in the Holter monitoring group
ICT-based ECG monitoring group	ICT-based ECG monitoring	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.

Primary Outcome Measures

Name	Time	Method
The difference in arrhythmia detection rate	12 months	The difference in arrhythmia detection rate between Holter monitoring and ICT-based centralized monitoring

Secondary Outcome Measures

Name	Time	Method
The difference in the number of hospital visits	12 months	The difference in the number of hospital visits during the study period due to arrhythmia
The difference in the recurrence rate of atrial fibrillation or atrial tachycardia	12 months	The difference in the recurrence rate of atrial fibrillation or atrial tachycardia within 1 year from atrial fibrillation ablation

Trial Locations

Locations (1)

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of