ICT-based Monitoring for Arrhythmia Detection After AF Ablation

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

Sponsors

Lead Sponsor: Keimyung University Dongsan Medical Center

Collaborator: Ministry of Trade, Industry & Energy, Republic of Korea
Korea Evaluation Institute of Industrial Technology
Daegu Metropolitan City, Korea
ICT Clinical Trial Coordination Center

Source Keimyung University Dongsan Medical Center
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.

Overall Status Unknown status
Start Date 2017-03-01
Completion Date 2018-08-31
Primary Completion Date 2018-08-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The difference in arrhythmia detection rate 12 months
Secondary Outcome
Measure Time Frame
The difference in the number of hospital visits 12 months
The difference in the recurrence rate of atrial fibrillation or atrial tachycardia 12 months
Enrollment 50
Condition
Intervention

Intervention Type: Device

Intervention Name: ICT-based ECG monitoring

Description: 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.

Arm Group Label: ICT-based ECG monitoring group

Intervention Type: Device

Intervention Name: Holter monitoring

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

Arm Group Label: Holter monitoring group

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

Gender:

All

Minimum Age:

20 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Hyoung-Seob Park, MD Principal Investigator Keimyung University Dongsan Medical Center
Overall Contact

Last Name: Hyoung-Seob Park, MD

Phone: +82-53-250-7314

Email: [email protected]

Location
Facility: Status: Contact: Keimyung University Dongsan Medical Center Hyoung-Seob Park, MD 82532507473 [email protected]
Location Countries

Korea, Republic of

Verification Date

2017-07-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: ICT-based ECG monitoring group

Type: Experimental

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.

Label: Holter monitoring group

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

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