<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/NCT03303872</url>
  </required_header>
  <id_info>
    <org_study_id>1-2017-0008</org_study_id>
    <nct_id>NCT03303872</nct_id>
  </id_info>
  <brief_title>Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)</brief_title>
  <official_title>Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is prospective Cohort study which was performed in multicenter (General Hospital)&#xD;
      in Korea. Inclusion criteria is patients post pacemaker implantation. The purpose is to&#xD;
      investigate the occurrence of device detected subclinical atrial fibrillation (atrial high&#xD;
      rate episode) in patients post pacemaker implantation and assess long term clinical results.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 31, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Occurrence of subclinical atrial fibrillation (atrial high rate episode)</measure>
    <time_frame>3 months after pacemaker implantation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of subclinical atrial fibrillation (atrial high rate episode)</measure>
    <time_frame>6 months after pacemaker implantation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of subclinical atrial fibrillation (atrial high rate episode)</measure>
    <time_frame>every 1 year upto 3 years after pacemaker implantation</time_frame>
    <description>Occurrence of subclinical atrial fibrillation (atrial high rate episode) during 36 months (3 years) post pacemaker implant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of stroke</measure>
    <time_frame>3 months after pacemaker implantation</time_frame>
    <description>Stroke based on device detected subclinical atrial fibrillation episodes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of stroke</measure>
    <time_frame>6 months after pacemaker implantation</time_frame>
    <description>Stroke based on device detected subclinical atrial fibrillation episodes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of stroke</measure>
    <time_frame>every 1 year upto 3 years after pacemaker implantation</time_frame>
    <description>Stroke based on device detected subclinical atrial fibrillation episodes</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">900</enrollment>
  <condition>Post Pacemaker Implantation Patients</condition>
  <arm_group>
    <arm_group_label>AF-pacemaker registry</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients post pacemaker implantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18-80 years&#xD;
&#xD;
          -  Patients eligible for the indications for permanent pacemaker implantation in&#xD;
             accordance with 2016 revised Korean indication guideline on cardiac pacemaker&#xD;
             implantation&#xD;
&#xD;
          -  Estimated percentage of atrial pacing &gt;40% under sinus rhythm (LR≥60bpm, close&#xD;
             hysteresis and rest rate)&#xD;
&#xD;
          -  Estimated percentage of ventricular pacing &gt;40% under sinus rhythm (LR≥40bpm, DDD&#xD;
             pacing, close hysteresis and rest rate)&#xD;
&#xD;
          -  Patients who are willing to sign the informed consent.&#xD;
&#xD;
          -  Patients who are willing to receive the implantation and post-operative follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persistent or permanent AF&#xD;
&#xD;
          -  Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper&#xD;
             limit; SCr &gt; 3.5 mg/dl or Ccr &lt; 30ml/min)&#xD;
&#xD;
          -  Thyroid gland dysfunction&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Malignant tumor&#xD;
&#xD;
          -  Severe organic heart disease (such as moderate to severe mitral regurgitation, dilated&#xD;
             cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)&#xD;
&#xD;
          -  Life expectancy &lt; 12 months&#xD;
&#xD;
          -  Patients unable or unwilling to cooperate in the study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Boyoung Joung, M.D., Ph.D.</last_name>
    <phone>82-10-8025-0424</phone>
    <email>CBY6908@yuhs.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boyoung Joung, M.D., Ph.D.</last_name>
      <phone>82-10-8025-0424</phone>
      <email>CBY690@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 17, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>June 19, 2018</last_update_submitted>
  <last_update_submitted_qc>June 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atrial high rate episode</keyword>
  <keyword>pacemaker</keyword>
  <keyword>atrial fibrillation</keyword>
  <keyword>stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Atrioventricular Block</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/NCT03303872
org study id: 1-2017-0008
nct id: NCT03303872
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is prospective Cohort study which was performed in multicenter (General Hospital)
      in Korea. Inclusion criteria is patients post pacemaker implantation. The purpose is to
      investigate the occurrence of device detected subclinical atrial fibrillation (atrial high
      rate episode) in patients post pacemaker implantation and assess long term clinical results.
observational model: Cohort
time perspective: Prospective
measure: Occurrence of subclinical atrial fibrillation (atrial high rate episode)
time frame: 3 months after pacemaker implantation
measure: Occurrence of subclinical atrial fibrillation (atrial high rate episode)
time frame: 6 months after pacemaker implantation
measure: Occurrence of subclinical atrial fibrillation (atrial high rate episode)
time frame: every 1 year upto 3 years after pacemaker implantation
description: Occurrence of subclinical atrial fibrillation (atrial high rate episode) during 36 months (3 years) post pacemaker implant
measure: Occurrence of stroke
time frame: 3 months after pacemaker implantation
description: Stroke based on device detected subclinical atrial fibrillation episodes
measure: Occurrence of stroke
time frame: 6 months after pacemaker implantation
description: Stroke based on device detected subclinical atrial fibrillation episodes
measure: Occurrence of stroke
time frame: every 1 year upto 3 years after pacemaker implantation
description: Stroke based on device detected subclinical atrial fibrillation episodes
arm group label: AF-pacemaker registry
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Boyoung Joung, M.D., Ph.D.
phone: 82-10-8025-0424
email: CBY6908@yuhs.ac
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Atrioventricular Block