- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03256812
ICT-based Monitoring for Arrhythmia Detection After AF Ablation
October 17, 2023 updated by: Keimyung University Dongsan Medical Center
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hyoung-Seob Park, MD
- Phone Number: +82-53-250-7314
- Email: drparkgyver@gmail.com
Study Contact Backup
- Name: Kyung-Min Lee
- Phone Number: +82-53-250-7314
- Email: kyungmin2@dsmc.or.kr
Study Locations
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Daegu, Korea, Republic of, 700-712
- Keimyung University Dongsan Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ICT-based ECG monitoring group
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.
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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.
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Active Comparator: Holter monitoring group
24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups in the Holter monitoring group
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24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference in arrhythmia detection rate
Time Frame: 12 months
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The difference in arrhythmia detection rate between Holter monitoring and ICT-based centralized monitoring
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference in the number of hospital visits
Time Frame: 12 months
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The difference in the number of hospital visits during the study period due to arrhythmia
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12 months
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The difference in the recurrence rate of atrial fibrillation or atrial tachycardia
Time Frame: 12 months
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The difference in the recurrence rate of atrial fibrillation or atrial tachycardia within 1 year from atrial fibrillation ablation
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Hyoung-Seob Park, MD, Keimyung University Dongsan Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Actual)
August 31, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
August 16, 2017
First Submitted That Met QC Criteria
August 20, 2017
First Posted (Actual)
August 22, 2017
Study Record Updates
Last Update Posted (Actual)
October 18, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICT_CM_P03_AF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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