<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/NCT02260206</url>
  </required_header>
  <id_info>
    <org_study_id>colchicine</org_study_id>
    <nct_id>NCT02260206</nct_id>
  </id_info>
  <brief_title>Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion</brief_title>
  <official_title>Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion Following Catheter Ablation of Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yong Seog Oh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul St. Mary's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effects colchicine administration for acute pericardial effusion after radiofrequency&#xD;
      catheter ablation (RFCA) of atrial fibrillation on the recurrences of arrhythmia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RFCA was started as a rhythm control of atrial fibrillation about 10 years before and the&#xD;
      superiority of RFCA to medical treatment has been continuously reporting, so RFCA is globally&#xD;
      performed nowadays. Acute pericardial effusion could occur during RFCA as complication, that&#xD;
      might be developed to cardiac tamponade needed immediate pericardiocentesis. The inflammation&#xD;
      developed after pericardiocentesis might be associated with the recurrences of atrial&#xD;
      fibrillation, it could be presumed by the frequent occurrence of atrial fibrillation after&#xD;
      open-heart surgery. The inflammation can be suppressed by administration of colchicine and&#xD;
      the effects of colchicine have been proven to decrease the development of atrial&#xD;
      fibrillation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>recurrence of atrial arrhythimia</measure>
    <time_frame>1 year after colchicines administration</time_frame>
    <description>Assessment of the recurrence of atrial arrhythimia 1 year after colchicines administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>recurrence of atrial arrhythimia</measure>
    <time_frame>3 year after colchicines administration</time_frame>
    <description>Assessment of the recurrence of atrial arrhythimia 3 year after colchicines administration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Pericardial Effusion</condition>
  <arm_group>
    <arm_group_label>Colchicine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Colchicine</intervention_name>
    <description>Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation</description>
    <arm_group_label>Colchicine</arm_group_label>
    <other_name>Impact of Colchicine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients needed to pericardiocentesis during RFCA for paroxysmal or persistent atrial&#xD;
             fibrillation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity on Colchicine&#xD;
&#xD;
          -  The existence of intra-cardiac thrombus on trans-esophageal echocardiography&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yong Seog Oh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul St. Mary's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sung Hwan Kim, professor</last_name>
    <phone>82-2-2258-1141</phone>
    <email>sunghwan@catholic.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul St Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Seo Cho Gu</state>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>In Ae Jung, coordinator</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>October 5, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>April 4, 2019</last_update_submitted>
  <last_update_submitted_qc>April 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Seoul St. Mary's Hospital</investigator_affiliation>
    <investigator_full_name>Yong Seog Oh</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Pericardial Effusion</keyword>
  <keyword>Colchicine</keyword>
  <keyword>arrhythmia Recurrence</keyword>
  <keyword>pericardiocentesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Pericardial Effusion</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colchicine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02260206
org study id: colchicine
nct id: NCT02260206
lead sponsor: 
has dmc: Yes
The effects colchicine administration for acute pericardial effusion after radiofrequency
      catheter ablation (RFCA) of atrial fibrillation on the recurrences of arrhythmia.
RFCA was started as a rhythm control of atrial fibrillation about 10 years before and the
      superiority of RFCA to medical treatment has been continuously reporting, so RFCA is globally
      performed nowadays. Acute pericardial effusion could occur during RFCA as complication, that
      might be developed to cardiac tamponade needed immediate pericardiocentesis. The inflammation
      developed after pericardiocentesis might be associated with the recurrences of atrial
      fibrillation, it could be presumed by the frequent occurrence of atrial fibrillation after
      open-heart surgery. The inflammation can be suppressed by administration of colchicine and
      the effects of colchicine have been proven to decrease the development of atrial
      fibrillation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: recurrence of atrial arrhythimia
time frame: 1 year after colchicines administration
description: Assessment of the recurrence of atrial arrhythimia 1 year after colchicines administration
measure: recurrence of atrial arrhythimia
time frame: 3 year after colchicines administration
description: Assessment of the recurrence of atrial arrhythimia 3 year after colchicines administration
arm group label: Colchicine
arm group type: Experimental
description: Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation
arm group label: No intervention
arm group type: No Intervention
description: No intervention
intervention type: Drug
intervention name: Colchicine
description: Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation
arm group label: Colchicine
other name: Impact of Colchicine
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yong Seog Oh, MD
role: Principal Investigator
affiliation: Seoul St. Mary's Hospital
last name: Sung Hwan Kim, professor
phone: 82-2-2258-1141
email: sunghwan@catholic.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Seoul St. Mary's Hospital
investigator full name: Yong Seog Oh
investigator title: MD
mesh term: Arrhythmias, Cardiac
mesh term: Pericardial Effusion
mesh term: Recurrence
mesh term: Colchicine
sharing ipd: No