Status:
COMPLETED
ICT-based Monitoring for Arrhythmia Detection After AF Ablation
Lead Sponsor:
Keimyung University Dongsan Medical Center
Collaborating Sponsors:
Ministry of Trade, Industry & Energy, Republic of Korea
Korea Evaluation Institute of Industrial Technology
Conditions:
Arrhythmias, Cardiac
Atrial Fibrillation
Eligibility:
All Genders
20-80 years
Phase:
NA
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...
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 fibr...
Eligibility Criteria
Inclusion
- Age ≥ 20 years, but \< 80 years
- Patients with non-valvular atrial fibrillation
- 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
- Patients who can be followed-up for at least 3 months after ablation
- Patients who can use and consent to use smartphone-based ECG monitoring
- Patients who can use a smartphone (Android, version 5.0 or lower; development planned for version 6.0 or higher)
- 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
- Patients who cannot be monitored by a smartphone or Bluetooth device
- Patients who cannot use a smartphone, Bluetooth device, or the internet due to old age
- Patients with contraindications to standard therapy, such as continued anticoagulant therapy before and after atrial fibrillation ablation
- Patients belonging to a population vulnerable to clinical trials
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03256812
Start Date
March 1 2017
End Date
December 31 2018
Last Update
October 18 2023
Active Locations (1)
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1
Keimyung University Dongsan Medical Center
Daegu, South Korea, 700-712