Arrhythmias, CardiacNCT03256812
ICT-based Monitoring for Arrhythmia Detection After AF Ablation
A study testing ICT-based ECG monitoring and Holter monitoring in people with Arrhythmias, Cardiac and Atrial Fibrillation, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Arrhythmias, Cardiac, Atrial Fibrillation
- What is being tested?
- ICT-based ECG monitoring and Holter monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Keimyung University Dongsan Medical Center
Daegu, 700-712
About this study
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
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
Read the 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.
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation
- Being tested
- ICT-based ECG monitoring, Holter monitoring
- Keywords
- Arrhythmias, Atrial Fibrillation
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICT-based ECG monitoringDevice
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 monitoringDevice
24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups
| Study group | Role | What they receive |
|---|---|---|
| ICT-based ECG monitoring group | Experimental | 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. Receives: Device: ICT-based ECG monitoring |
| Holter monitoring group | Active comparator | 24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups in the Holter monitoring group Receives: Device: Holter monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in arrhythmia detection rate
The difference in arrhythmia detection rate between Holter monitoring and ICT-based centralized monitoring
Measured: 12 months
Secondary outcomes (2)
The difference in the number of hospital visits
The difference in the number of hospital visits during the study period due to arrhythmia
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start1 Mar 2017
- Primary completion31 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea, Korea Evaluation Institute of Industrial Technology, Daegu Metropolitan City, Korea, ICT Clinical Trial Coordination Center
- Responsible party
- Sponsor
- Investigators
- Hyoung-Seob Park, MD, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256812
- Sponsor's protocol ID
- ICT_CM_P03_AF
- Status last verified
- Mar 2019
- First submitted
- 16 Aug 2017
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03256812
- Acronym / sponsor ID
- ICT_CM_P03_AF
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation
- Keywords
- Arrhythmias, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea, Korea Evaluation Institute of Industrial Technology, Daegu Metropolitan City, Korea, ICT Clinical Trial Coordination Center
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICT-based ECG monitoring group | Experimental | Device: ICT-based ECG monitoringContinuous 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. |
| Holter monitoring group | Active comparator | Device: Holter monitoring24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups in the Holter monitoring group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICT-based ECG monitoringContinuous 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. | Device | ICT-based ECG monitoring group |
| Holter monitoring24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups | Device | Holter monitoring group |
Primary outcome
The difference in arrhythmia detection rate
Time frame: 12 months
The difference in arrhythmia detection rate between Holter monitoring and ICT-based centralized monitoring
2 secondary outcomes
The difference in the number of hospital visits
Time frame: 12 months
The difference in the recurrence rate of atrial fibrillation or atrial tachycardia
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyoung-Seob Park, MD principal investigator
Keimyung University Dongsan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICT-based ECG monitoring and Holter monitoring in people with Arrhythmias, Cardiac and Atrial Fibrillation, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in arrhythmia detection rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.