<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/NCT02230748</url>
  </required_header>
  <id_info>
    <org_study_id>LAARGE</org_study_id>
    <nct_id>NCT02230748</nct_id>
  </id_info>
  <brief_title>Left-Atrium-Appendage Occluder Register - GErmany</brief_title>
  <acronym>LAARGE</acronym>
  <official_title>Left-Atrium-Appendage Occluder Register - GErmany</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stiftung Institut fuer Herzinfarktforschung</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stiftung Institut fuer Herzinfarktforschung</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Evaluation of safety and effectiveness of implantable LAA occluder in clinical practice&#xD;
&#xD;
        -  Indication: For which reasons is the indication for implantation of LAA-Occluder put for&#xD;
           patients with atrial fibrillation?&#xD;
&#xD;
        -  Safety: How save is the implantation of LAA-Occluders?&#xD;
&#xD;
        -  Effectiveness: How effective is implantation of LAA-Occluders in daily clinical&#xD;
           practice?&#xD;
&#xD;
        -  Concomitant treatment: Which concomitant treatment is prescribed for patients with&#xD;
           LAA-Occluder?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      LAARGE aims to show the care reality of patients whose left atrial appendage (LAA) is closed&#xD;
      by an implantable medical device. In particular the following questions should be answered:&#xD;
&#xD;
        -  Indication: For which reasons is the indication for implantation of LAA-Occluder put for&#xD;
           patients with atrial fibrillation?&#xD;
&#xD;
        -  Safety: How save is the implantation of LAA-Occluders (procedural, in hospital and in&#xD;
           the long term course)? How frequent are bleeding complications and what is the relation&#xD;
           of observed and expected bleeding complications (according HAS-BLED score)?&#xD;
&#xD;
        -  Effectiveness: How effective is implantation of LAA-Occluders in daily clinical practice&#xD;
           (in hospital and in the long term course)? How frequent are strokes and what is the&#xD;
           relation of observed and expected strokes (according CHADS-VASC score)?&#xD;
&#xD;
        -  Concomitant treatment: Which concomitant treatment is prescribed for patients with&#xD;
           LAA-Occluder?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 27, 2017</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Safety: clinical events with LAA occlusion</measure>
    <time_frame>1 year follow-up (optional 2,3,5 years)</time_frame>
    <description>Documentation of reasons for LAA Occluder Implantation.&#xD;
Periprocedural and hospital: death, bleeding, pericardial effusion, reanimation, occluder dislocation and further complications.&#xD;
Long term follow-up:: death, bleeding, pericardial effusion, reanimation, occluder dislocation, further complications and patients safety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: LAA occlusion</measure>
    <time_frame>1 year follow-up (optional 2,3,5 years)</time_frame>
    <description>periprocedural and hospital: Sudden or unexpected death, stroke, TIA, systemic embolism, technical success.&#xD;
Long term follow-up: Sudden or unexpected death, stroke, TIA, systemic embolism, patients satisfaction.</description>
  </secondary_outcome>
  <enrollment type="Actual">643</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Stroke</condition>
  <eligibility>
    <study_pop>
      <textblock>
        all patients with an performed or planned LAA -Occluder&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Intention to laa occluder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Missing informed consent&#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>Jochen Senges, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stiftung Institut für Herzinfarktforschung (IHF)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum Coburg</name>
      <address>
        <city>Coburg</city>
        <zip>96450</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut für Herzinfarkforschung Ludwigshafen</name>
      <address>
        <city>Ludwigshafen</city>
        <zip>67063</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Mannheim</name>
      <address>
        <city>Mannheim</city>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isar Herzzentrum</name>
      <address>
        <city>München</city>
        <zip>80331</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>September 5, 2018</last_update_submitted>
  <last_update_submitted_qc>September 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>LAA</keyword>
  <keyword>LAA-Occluder</keyword>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>AF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_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/NCT02230748
org study id: LAARGE
nct id: NCT02230748
lead sponsor: 
has dmc: No
-  Evaluation of safety and effectiveness of implantable LAA occluder in clinical practice

        -  Indication: For which reasons is the indication for implantation of LAA-Occluder put for
           patients with atrial fibrillation?

        -  Safety: How save is the implantation of LAA-Occluders?

        -  Effectiveness: How effective is implantation of LAA-Occluders in daily clinical
           practice?

        -  Concomitant treatment: Which concomitant treatment is prescribed for patients with
           LAA-Occluder?
LAARGE aims to show the care reality of patients whose left atrial appendage (LAA) is closed
      by an implantable medical device. In particular the following questions should be answered:

        -  Indication: For which reasons is the indication for implantation of LAA-Occluder put for
           patients with atrial fibrillation?

        -  Safety: How save is the implantation of LAA-Occluders (procedural, in hospital and in
           the long term course)? How frequent are bleeding complications and what is the relation
           of observed and expected bleeding complications (according HAS-BLED score)?

        -  Effectiveness: How effective is implantation of LAA-Occluders in daily clinical practice
           (in hospital and in the long term course)? How frequent are strokes and what is the
           relation of observed and expected strokes (according CHADS-VASC score)?

        -  Concomitant treatment: Which concomitant treatment is prescribed for patients with
           LAA-Occluder?
observational model: Case-Only
time perspective: Prospective
measure: Safety: clinical events with LAA occlusion
time frame: 1 year follow-up (optional 2,3,5 years)
description: Documentation of reasons for LAA Occluder Implantation.
Periprocedural and hospital: death, bleeding, pericardial effusion, reanimation, occluder dislocation and further complications.
Long term follow-up:: death, bleeding, pericardial effusion, reanimation, occluder dislocation, further complications and patients safety.
measure: Effectiveness: LAA occlusion
time frame: 1 year follow-up (optional 2,3,5 years)
description: periprocedural and hospital: Sudden or unexpected death, stroke, TIA, systemic embolism, technical success.
Long term follow-up: Sudden or unexpected death, stroke, TIA, systemic embolism, patients satisfaction.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jochen Senges, MD
role: Principal Investigator
affiliation: Stiftung Institut für Herzinfarktforschung (IHF)
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No