<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/NCT03279406</url>
  </required_header>
  <id_info>
    <org_study_id>Cardio Tours RELEXAO</org_study_id>
    <nct_id>NCT03279406</nct_id>
  </id_info>
  <brief_title>REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion</brief_title>
  <acronym>RELEXAO</acronym>
  <official_title>REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion for Patients With Atrial Fibrillation in France</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</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>
      The objective of this observational non-randomized multicenter study is to compile real-world&#xD;
      clinical characteristics and outcomes data for patients treated with LAA (left atrial&#xD;
      appendage) closure systems in a daily clinical setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2012</start_date>
  <completion_date type="Actual">September 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>60 Months</target_duration>
  <primary_outcome>
    <measure>Major adverse cardiovascular events</measure>
    <time_frame>From date of inclusion until the date of first documented event, whichever came first, assessed up to 60 months</time_frame>
    <description>Death, Ischemic stroke, Transient ischemic attack, Major hemorrhage, Thrombus on device</description>
  </primary_outcome>
  <enrollment type="Actual">400</enrollment>
  <condition>Atrial Fibrillation</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous Left Atrial Appendage Occlusion</intervention_name>
    <description>Percutaneous left atrial appendage occlusion in routine care for patients with atrial fibrillation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients treated with percutaneous Left Atrial Appendage Occlusion among those referred&#xD;
        to one of the French centers involved in this database&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are eligible for a LAA occlusion device and treated with a commercially&#xD;
             available device according to international and local guidelines and per physician&#xD;
             discretion.&#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>Laurent Fauchier, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Tours</affiliation>
  </overall_official>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Tours</investigator_affiliation>
    <investigator_full_name>Laurent Fauchier</investigator_full_name>
    <investigator_title>Professor of Cardiology</investigator_title>
  </responsible_party>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Stroke</keyword>
  <keyword>Thrombus</keyword>
  <keyword>Left atrial appendage</keyword>
  <keyword>Bleeding</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/NCT03279406
org study id: Cardio Tours RELEXAO
nct id: NCT03279406
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this observational non-randomized multicenter study is to compile real-world
      clinical characteristics and outcomes data for patients treated with LAA (left atrial
      appendage) closure systems in a daily clinical setting.
observational model: Case-Only
time perspective: Prospective
measure: Major adverse cardiovascular events
time frame: From date of inclusion until the date of first documented event, whichever came first, assessed up to 60 months
description: Death, Ischemic stroke, Transient ischemic attack, Major hemorrhage, Thrombus on device
intervention type: Device
intervention name: Percutaneous Left Atrial Appendage Occlusion
description: Percutaneous left atrial appendage occlusion in routine care for patients with atrial fibrillation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laurent Fauchier, MD, PhD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Tours
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Tours
investigator full name: Laurent Fauchier
investigator title: Professor of Cardiology
mesh term: Atrial Fibrillation