Arrhythmias, Cardiac, Atrial Fibrillation
Conditions
Keywords
Arrhythmias, Atrial Fibrillation
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.
Interventions
DEVICEICT-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.
DEVICEHolter monitoring
24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups
Sponsors
Ministry of Trade, Industry & Energy, Republic of Korea
Korea Evaluation Institute of Industrial Technology
Daegu Metropolitan City, Korea
ICT Clinical Trial Coordination Center
Keimyung University Dongsan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in arrhythmia detection rate | 12 months | The difference in arrhythmia detection rate between Holter monitoring and ICT-based centralized monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed