ICT-based Monitoring for Arrhythmia Detection After AF Ablation

Keimyung University

Status: Completed

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac

Treatments: Device: Holter monitoring; Device: ICT-based ECG monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03256812

ICT_CM_P03_AF

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

ICT-based ECG monitoring group

Experimental group

Description:

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.

Treatment:

Device: ICT-based ECG monitoring

Holter monitoring group

Active Comparator group

Description:

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

Treatment:

Device: Holter monitoring