ICT-based Monitoring for Arrhythmia Detection After AF Ablation

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256812
• Other study ID #: ICT_CM_P03_AF
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2019
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu

Sponsors (5)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center	Daegu Metropolitan City, Korea, ICT Clinical Trial Coordination Center, Korea Evaluation Institute of Industrial Technology, Ministry of Trade, Industry & Energy, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in arrhythmia detection rate	The difference in arrhythmia detection rate between Holter monitoring and ICT-based centralized monitoring	12 months
Secondary	The difference in the number of hospital visits	The difference in the number of hospital visits during the study period due to arrhythmia	12 months
Secondary	The difference in the recurrence rate of atrial fibrillation or atrial tachycardia	The difference in the recurrence rate of atrial fibrillation or atrial tachycardia within 1 year from atrial fibrillation ablation	12 months