<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03256812</url>
  </required_header>
  <id_info>
    <org_study_id>ICT_CM_P03_AF</org_study_id>
    <nct_id>NCT03256812</nct_id>
  </id_info>
  <brief_title>ICT-based Monitoring for Arrhythmia Detection After AF Ablation</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Keimyung University Dongsan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Trade, Industry &amp; Energy, Republic of Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Korea Evaluation Institute of Industrial Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daegu Metropolitan City, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ICT Clinical Trial Coordination Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Keimyung University Dongsan Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the efficacy and stability of an ICT-based centralized clinical trial monitoring&#xD;
      system against the efficacy and stability of an existing outpatient-based electrocardiogram&#xD;
      (ECG) and Holter monitoring system for arrhythmia detection after atrial fibrillation&#xD;
      ablation, and to test whether such continuous monitoring can better detect arrhythmia that is&#xD;
      undetectable by existing methods and how this may affect treatment outcomes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial is a prospective, randomized, controlled, multicenter study in patients&#xD;
      who are capable of using and consent to use a smartphone-based ECG monitoring after ablation&#xD;
      for atrial fibrillation. The patients will be randomly assigned to either the Holter&#xD;
      monitoring or ICT-based centralized clinical trial monitoring system group in a 1:1 ratio and&#xD;
      will undergo monitoring from immediately after the procedure to 12 months after discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference in arrhythmia detection rate</measure>
    <time_frame>12 months</time_frame>
    <description>The difference in arrhythmia detection rate between Holter monitoring and ICT-based centralized monitoring</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The difference in the number of hospital visits</measure>
    <time_frame>12 months</time_frame>
    <description>The difference in the number of hospital visits during the study period due to arrhythmia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The difference in the recurrence rate of atrial fibrillation or atrial tachycardia</measure>
    <time_frame>12 months</time_frame>
    <description>The difference in the recurrence rate of atrial fibrillation or atrial tachycardia within 1 year from atrial fibrillation ablation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Arrhythmias, Cardiac</condition>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>ICT-based ECG monitoring group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Holter monitoring group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups in the Holter monitoring group</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ICT-based ECG monitoring</intervention_name>
    <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.</description>
    <arm_group_label>ICT-based ECG monitoring group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Holter monitoring</intervention_name>
    <description>24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups</description>
    <arm_group_label>Holter monitoring group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 20 years, but &lt; 80 years&#xD;
&#xD;
          2. Patients with non-valvular atrial fibrillation&#xD;
&#xD;
          3. Patients with sustained atrial fibrillation despite ≥ 6 weeks of continuous&#xD;
             antiarrhythmia therapy or those who underwent an ablation procedure for&#xD;
             tachy-bradycardia syndrome within the previous week&#xD;
&#xD;
          4. Patients who can be followed-up for at least 3 months after ablation&#xD;
&#xD;
          5. Patients who can use and consent to use smartphone-based ECG monitoring&#xD;
&#xD;
          6. Patients who can use a smartphone (Android, version 5.0 or lower; development planned&#xD;
             for version 6.0 or higher)&#xD;
&#xD;
          7. Those who can connect to the internet via LAN or WiFi and are in an environment where&#xD;
             they can use a gateway and smartphone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who cannot be monitored by a smartphone or Bluetooth device&#xD;
&#xD;
          2. Patients who cannot use a smartphone, Bluetooth device, or the internet due to old age&#xD;
&#xD;
          3. Patients with contraindications to standard therapy, such as continued anticoagulant&#xD;
             therapy before and after atrial fibrillation ablation&#xD;
&#xD;
          4. Patients belonging to a population vulnerable to clinical trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyoung-Seob Park, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Keimyung University Dongsan Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hyoung-Seob Park, MD</last_name>
    <phone>+82-53-250-7314</phone>
    <email>drparkgyver@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kyung-Min Lee</last_name>
    <phone>+82-53-250-7314</phone>
    <email>kyungmin2@dsmc.or.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>700-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hyoung-Seob Park, MD</last_name>
      <phone>82532507473</phone>
      <email>drparkgyver@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 20, 2017</last_update_submitted>
  <last_update_submitted_qc>August 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Arrhythmias, Atrial Fibrillation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03256812
org study id: ICT_CM_P03_AF
nct id: NCT03256812
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The difference in arrhythmia detection rate
time frame: 12 months
description: The difference in arrhythmia detection rate between Holter monitoring and ICT-based centralized monitoring
measure: The difference in the number of hospital visits
time frame: 12 months
description: The difference in the number of hospital visits during the study period due to arrhythmia
measure: The difference in the recurrence rate of atrial fibrillation or atrial tachycardia
time frame: 12 months
description: The difference in the recurrence rate of atrial fibrillation or atrial tachycardia within 1 year from atrial fibrillation ablation
arm group label: ICT-based ECG monitoring group
arm 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.
arm group label: Holter monitoring group
arm 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
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
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hyoung-Seob Park, MD
role: Principal Investigator
affiliation: Keimyung University Dongsan Medical Center
last name: Hyoung-Seob Park, MD
phone: +82-53-250-7314
email: drparkgyver@gmail.com
last name: Kyung-Min Lee
phone: +82-53-250-7314
email: kyungmin2@dsmc.or.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Arrhythmias, Cardiac