<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/NCT02216903</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0502</org_study_id>
    <nct_id>NCT02216903</nct_id>
  </id_info>
  <brief_title>Respiratory Motion Related Ablation Gap and Clinical Outcome After Catheter Ablation for Atrial Fibrillation</brief_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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is the evaluation which is associated with apnea symptom, one of the recurrence factors,&#xD;
      after AF ablation to patients who diagnosed AF.&#xD;
&#xD;
      This is the evaluation which is associated with excessive respiration exercise during AF&#xD;
      ablation to patients who diagnosed AF.&#xD;
&#xD;
      This is the evaluation which is associated with excessive respiration exercise to make a gap&#xD;
      during AF ablation to patients who diagnosed AF.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Clinical recurrence of atrial fibrillation (AF) after catheter ablation</measure>
    <time_frame>after 90 days of catheter ablation and thereafter</time_frame>
    <description>We defined recurrence of AF as any episode of AF or atrial tachycardia lasting longer than 30 sec. Any ECG documentation of AF recurrence after 3 months was diagnosed as clinical recurrence.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">510</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Yonsei AF Cohort</arm_group_label>
    <description>Patients with atrial fibrillation who undergoing catheter ablation of atrial fibrillation</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients with atrial fibrillation who undergoing catheter ablation in Yonsei&#xD;
        Cardiovascular hospital, Yonsei university health system, Seoul, Korea.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 20~80&#xD;
&#xD;
          2. Left atrium size &lt;55mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Permeant AF which is uncontrolled by cardioverting&#xD;
&#xD;
          2. Valvular AF (mitral stenosis&gt; grade 2, mitral valvuloplasty)&#xD;
&#xD;
          3. Structural heart disease which is necessary operation to be healed.&#xD;
&#xD;
          4. The patients who had history of ablation or maze operation&#xD;
&#xD;
          5. The patients who have abnormal respiration by spinal or chest modification.&#xD;
&#xD;
          6. accompany Severe disease in present&#xD;
&#xD;
          7. Under age &lt;20&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>March 26, 2019</last_update_submitted>
  <last_update_submitted_qc>March 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial fibrillation, sleep apnea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</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/NCT02216903
org study id: 4-2014-0502
nct id: NCT02216903
lead sponsor: 
has dmc: No
This is the evaluation which is associated with apnea symptom, one of the recurrence factors,
      after AF ablation to patients who diagnosed AF.

      This is the evaluation which is associated with excessive respiration exercise during AF
      ablation to patients who diagnosed AF.

      This is the evaluation which is associated with excessive respiration exercise to make a gap
      during AF ablation to patients who diagnosed AF.
observational model: Cohort
time perspective: Prospective
measure: Clinical recurrence of atrial fibrillation (AF) after catheter ablation
time frame: after 90 days of catheter ablation and thereafter
description: We defined recurrence of AF as any episode of AF or atrial tachycardia lasting longer than 30 sec. Any ECG documentation of AF recurrence after 3 months was diagnosed as clinical recurrence.
arm group label: Yonsei AF Cohort
description: Patients with atrial fibrillation who undergoing catheter ablation of atrial fibrillation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Atrial Fibrillation