<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/NCT02190175</url>
  </required_header>
  <id_info>
    <org_study_id>AFFLEC</org_study_id>
    <nct_id>NCT02190175</nct_id>
  </id_info>
  <brief_title>Management of Atrial Fibrillation With Flecainide : the AFFLEC Study</brief_title>
  <official_title>Multicentre Non Interventional Study in the Management of Atrial Fibrillation With Flecainide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hellenic Cardiovascular Research Society</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hellenic Cardiovascular Research Society</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicentre non interventional observational study with the objective to follow up&#xD;
      patients with atrial fibrillation who based on current indications are treated with per os&#xD;
      flecainide , for cardiac pulse maintenance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the study objectives are&#xD;
&#xD;
        -  record safety and efficiency of flecainide as antiarrythmic treatment in atrial&#xD;
           fibrillation&#xD;
&#xD;
        -  study of flecainide in ST interval&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>ST interval and repolarization measures of myocardia in patients under treatment of flecainide</measure>
    <time_frame>6months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Atrial Fibrillation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with history of atrial fibrillation who are under treatment with per os flecainide&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with history of atrial fibrillation&#xD;
&#xD;
          -  patients able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with coronary disease or other cardiopathy with left heart champer affected&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Erythros Stavros Hospital</name>
      <address>
        <city>Athens</city>
        <zip>11526</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Larisa</name>
      <address>
        <city>Larisa</city>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AHEPA University Hospital</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54636</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>September 6, 2018</last_update_submitted>
  <last_update_submitted_qc>September 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02190175
org study id: AFFLEC
nct id: NCT02190175
lead sponsor: 
has dmc: No
This is a multicentre non interventional observational study with the objective to follow up
      patients with atrial fibrillation who based on current indications are treated with per os
      flecainide , for cardiac pulse maintenance.
the study objectives are

        -  record safety and efficiency of flecainide as antiarrythmic treatment in atrial
           fibrillation

        -  study of flecainide in ST interval
observational model: Cohort
time perspective: Prospective
measure: ST interval and repolarization measures of myocardia in patients under treatment of flecainide
time frame: 6months
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Greece
responsible party type: Sponsor
mesh term: Atrial Fibrillation