ICT-based Monitoring for Arrhythmia Detection After AF Ablation

NCT ID: NCT03256812

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-12-31

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.

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ICT-based ECG monitoring

Intervention Type: DEVICE

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 monitoring group

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

Group Type: ACTIVE_COMPARATOR

Holter monitoring

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Holter monitoring

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Trade, Industry & Energy, Republic of Korea

OTHER_GOV

Sponsor Role: collaborator

Korea Evaluation Institute of Industrial Technology

OTHER

Sponsor Role: collaborator

Daegu Metropolitan City, Korea

OTHER_GOV

Sponsor Role: collaborator

ICT Clinical Trial Coordination Center

OTHER

Sponsor Role: collaborator

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyoung-Seob Park, MD

Role: PRINCIPAL_INVESTIGATOR

Keimyung University Dongsan Medical Center

Locations

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Countries

South Korea

Other Identifiers

ICT_CM_P03_AF

Identifier Type: -

Identifier Source: org_study_id