Clinical trial NCT03256812: ICT-based Monitoring for Arrhythmia Detection After AF Ablation
Official title: Efficacy and Stability of an Information and Communication Technology (ICT)-Based Centralized Monitoring System for Arrhythmia Detection After Atrial Fibrillation Ablation: a Prospective, Randomized Controlled, Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmias, Cardiac
Atrial Fibrillation
Keywords: Arrhythmias, Atrial Fibrillation
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Trade, Industry & Energy, Republic of Korea
name: Korea Evaluation Institute of Industrial Technology
name: Daegu Metropolitan City, Korea
name: ICT Clinical Trial Coordination Center
First posted: 2017-08-22
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The difference in arrhythmia detection rate
timeFrame: 12 months
Secondary outcomes:
measure: The difference in the number of hospital visits
timeFrame: 12 months
measure: The difference in the recurrence rate of atrial fibrillation or atrial tachycardia
timeFrame: 12 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Hyoung-Seob Park, MD
role: PRINCIPAL_INVESTIGATOR
References: