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ICT-based Monitoring for Arrhythmia Detection After AF Ablation

Primary Purpose

Arrhythmias, Cardiac, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ICT-based ECG monitoring
Holter monitoring
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arrhythmias, Cardiac focused on measuring Arrhythmias, Atrial Fibrillation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keimyung University Dongsan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ICT-based ECG monitoring group

Holter monitoring group

Arm 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.

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

Outcomes

Primary Outcome Measures

The difference in arrhythmia detection rate
The difference in arrhythmia detection rate between Holter monitoring and ICT-based centralized monitoring

Secondary Outcome Measures

The difference in the number of hospital visits
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
The difference in the recurrence rate of atrial fibrillation or atrial tachycardia within 1 year from atrial fibrillation ablation

Full Information

First Posted
August 16, 2017
Last Updated
October 17, 2023
Sponsor
Keimyung University Dongsan Medical Center
Collaborators
Ministry of Trade, Industry & Energy, Republic of Korea, Korea Evaluation Institute of Industrial Technology, Daegu Metropolitan City, Korea, ICT Clinical Trial Coordination Center
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1. Study Identification

Unique Protocol Identification Number
NCT03256812
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keimyung University Dongsan Medical Center
Collaborators
Ministry of Trade, Industry & Energy, Republic of Korea, Korea Evaluation Institute of Industrial Technology, Daegu Metropolitan City, Korea, ICT Clinical Trial Coordination Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac, Atrial Fibrillation
Keywords
Arrhythmias, Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICT-based ECG monitoring group
Arm Type
Experimental
Arm 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.
Arm Title
Holter monitoring group
Arm Type
Active Comparator
Arm Description
24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups in the Holter monitoring group
Intervention Type
Device
Intervention Name(s)
ICT-based ECG monitoring
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Holter monitoring
Intervention Description
24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups
Primary Outcome Measure Information:
Title
The difference in arrhythmia detection rate
Description
The difference in arrhythmia detection rate between Holter monitoring and ICT-based centralized monitoring
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The difference in the number of hospital visits
Description
The difference in the number of hospital visits during the study period due to arrhythmia
Time Frame
12 months
Title
The difference in the recurrence rate of atrial fibrillation or atrial tachycardia
Description
The difference in the recurrence rate of atrial fibrillation or atrial tachycardia within 1 year from atrial fibrillation ablation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyoung-Seob Park, MD
Organizational Affiliation
Keimyung University Dongsan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

ICT-based Monitoring for Arrhythmia Detection After AF Ablation

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