<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/NCT02252861</url>
  </required_header>
  <id_info>
    <org_study_id>FLAAC</org_study_id>
    <nct_id>NCT02252861</nct_id>
  </id_info>
  <brief_title>French Database of Left Atrial Appendage Closure</brief_title>
  <acronym>FLAAC</acronym>
  <official_title>French Database of Left Atrial Appendage Closure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henri Mondor University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>French association for research in cardiology (ARCARD)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Henri Mondor University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium&#xD;
      that can induce cerebral vascular events or systemic embolisms. This justifies the&#xD;
      prescription of anticoagulant therapies in patients with high risk of thromboembolic event.&#xD;
      Percutaneous left atrial appendage closure is a new interventional strategy for patients with&#xD;
      high risk of cardiovascular events and a counter-indication for long term treatment with&#xD;
      anticoagulant agents. However, only few data are available on effectiveness and prognosis of&#xD;
      patients treated by this new interventional strategy.&#xD;
&#xD;
      This national database record per-procedure and follow-up data of patients treated by left&#xD;
      atrial appendage closure.&#xD;
&#xD;
      This database is strictly observational.&#xD;
&#xD;
      Percutaneous left atrial appendage closure is performed only for the purpose of patient care.&#xD;
      No specific intervention is performed specifically for the database. Neither left atrial&#xD;
      appendage closure procedure nor patient follow up are modified by patient inclusion in the&#xD;
      database.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2013</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</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>5 Years</target_duration>
  <primary_outcome>
    <measure>Assessment of the rate of thromboembolic events related to atrial fibrillation in patients treated by left atrial appendage closure in daily practice in France</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of patient management in daily practice after left atrial appendage closure (number of echocardiography procedures)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death rate from cardiovascular disease after left atrial appendage closure</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unexplained Death rate after left atrial appendage closure</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events related to the procedure</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of the procedure of left atrial appendage closure</measure>
    <time_frame>Costs will be assessed for the duration of hospital stay, an expected average of 3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of patient follow-up after left atrial appendage closure</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of patient medical treatment in daily practice after left atrial appendage closure (percentage of patients with antiplatelet drugs)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">840</enrollment>
  <condition>Atrial Fibrillation and Other Dysrhythmias | Patient</condition>
  <arm_group>
    <arm_group_label>Left Atrial Appendage Closure</arm_group_label>
    <description>Patients with atrial fibrillation and counter-indication to anticoagulant therapy referred for percutaneous Left Atrial Appendage Closure in routine care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Percutaneous Left Atrial Appendage Closure in routine care</intervention_name>
    <description>The inclusion in the database induces no specific intervention. Percutaneous Left Atrial Appendage Closure is performed for patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.</description>
    <arm_group_label>Left Atrial Appendage Closure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients referred for percutaneous Left Atrial Appendage Closure to one of the French&#xD;
        centers involved in this database&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients referred to a french interventional cardiology department for percutaneous&#xD;
             left atrial appendage closure in routine care&#xD;
&#xD;
          -  Signature of an inform consent form for inclusion of data recorded during care in the&#xD;
             database&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emmanuel Teiger, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>emmanuel.teiger@hmn.aphp.fr</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henri Mondor Hospital</name>
      <address>
        <city>Creteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henri Mondor University Hospital</investigator_affiliation>
    <investigator_full_name>Philippe Le Corvoisier</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </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/NCT02252861
org study id: FLAAC
nct id: NCT02252861
lead sponsor: 
collaborator: 
has dmc: Yes
Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium
      that can induce cerebral vascular events or systemic embolisms. This justifies the
      prescription of anticoagulant therapies in patients with high risk of thromboembolic event.
      Percutaneous left atrial appendage closure is a new interventional strategy for patients with
      high risk of cardiovascular events and a counter-indication for long term treatment with
      anticoagulant agents. However, only few data are available on effectiveness and prognosis of
      patients treated by this new interventional strategy.

      This national database record per-procedure and follow-up data of patients treated by left
      atrial appendage closure.

      This database is strictly observational.

      Percutaneous left atrial appendage closure is performed only for the purpose of patient care.
      No specific intervention is performed specifically for the database. Neither left atrial
      appendage closure procedure nor patient follow up are modified by patient inclusion in the
      database.
observational model: Cohort
time perspective: Prospective
measure: Assessment of the rate of thromboembolic events related to atrial fibrillation in patients treated by left atrial appendage closure in daily practice in France
time frame: 1 year
measure: Assessment of patient management in daily practice after left atrial appendage closure (number of echocardiography procedures)
time frame: 1 year
measure: Death rate from cardiovascular disease after left atrial appendage closure
time frame: 1 year
measure: Unexplained Death rate after left atrial appendage closure
time frame: 1 year
measure: Adverse events related to the procedure
time frame: 1 year
measure: Cost of the procedure of left atrial appendage closure
time frame: Costs will be assessed for the duration of hospital stay, an expected average of 3 days
measure: Cost of patient follow-up after left atrial appendage closure
time frame: 1 year
measure: Assessment of patient medical treatment in daily practice after left atrial appendage closure (percentage of patients with antiplatelet drugs)
time frame: 1 year
arm group label: Left Atrial Appendage Closure
description: Patients with atrial fibrillation and counter-indication to anticoagulant therapy referred for percutaneous Left Atrial Appendage Closure in routine care
intervention type: Other
intervention name: Percutaneous Left Atrial Appendage Closure in routine care
description: The inclusion in the database induces no specific intervention. Percutaneous Left Atrial Appendage Closure is performed for patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.
arm group label: Left Atrial Appendage Closure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emmanuel Teiger, MD, PhD
role: Principal Investigator
affiliation: emmanuel.teiger@hmn.aphp.fr
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Henri Mondor University Hospital
investigator full name: Philippe Le Corvoisier
investigator title: MD
mesh term: Atrial Fibrillation