<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/NCT02985463</url>
  </required_header>
  <id_info>
    <org_study_id>2014-402M-MA-§ 23b MPG</org_study_id>
    <nct_id>NCT02985463</nct_id>
  </id_info>
  <brief_title>Left Atrial Appendage Occlusion and Biomarker Evaluation</brief_title>
  <acronym>LABEL</acronym>
  <official_title>Left Atrial Appendage Occlusion and Biomarker Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsmedizin Mannheim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsmedizin Mannheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;Left Atrial Appendage Occlusion and Biomarker Evaluation&quot; (LABEL) is a single-center,&#xD;
      prospective and observational study evaluating changes of the expression of biomarkers in&#xD;
      eligible patients before and after percutaneous implantation of a left atrial appendage (LAA)&#xD;
      occlusion device at mid-term follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the changes of different types of biomarkers before and after&#xD;
      successful percutaneous implantation of an LAA occlusion device.&#xD;
&#xD;
      Biomarker evaluation will focus on blood derived biomarkers including neurohormones,&#xD;
      proteins, cytokines, microRNAs and metabolomics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Biomarker levels before successful LAA occlusion device implantation</measure>
    <time_frame>24 hours before intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarker levels after successful LAA occlusion device implantation</measure>
    <time_frame>mid-term follow up at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of biomarker expression before and after device implantation over mid-term follow-up, depending of complete, incomplete occlusion, imaging data (transesophageal echocardiography, computed tomography)</measure>
    <time_frame>mid-term follow up at 6 months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Stroke</condition>
  <condition>Atrial Fibrillation</condition>
  <condition>Bleeding</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Two peripheral blood withdraws in EDTA, citrate, ammonium heparin, serum tubes 24 hours&#xD;
      before and at mid-term follow up at 6 months after successful LAA occlusion device&#xD;
      implantation.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from non valvular atrial fibrillation with a contraindication for oral&#xD;
        anticoagulation (i.e. bleeding) being eligible of percutaneous implantation of LAA&#xD;
        occlusion devices.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non valvular atrial fibrillation, that makes anticoagulation to prevent embolic stroke&#xD;
             from the LAA&#xD;
&#xD;
          -  contraindication for the therapy with oral anticoagulants:&#xD;
&#xD;
          -  refusal to take oral anticoagulation&#xD;
&#xD;
          -  HasBled-score more than 3&#xD;
&#xD;
          -  prior bleedings under oral anticoagulation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 18 years&#xD;
&#xD;
          -  severely reduced left atrial function&#xD;
&#xD;
          -  mechanical heart valve&#xD;
&#xD;
          -  pulmonary embolism&#xD;
&#xD;
          -  deep vein thrombosis&#xD;
&#xD;
          -  myocardial infarction within the last 3 months&#xD;
&#xD;
          -  electrical cardioversion within 30 days after potential occluder implantation&#xD;
&#xD;
          -  atrial septum defect or interventional/surgical occlusion of ASD&#xD;
&#xD;
          -  status after heart transplant&#xD;
&#xD;
          -  symptomatic carotid artery stenosis&#xD;
&#xD;
          -  transient ischemic attack (TIA) or stroke within last 30 days&#xD;
&#xD;
          -  intracerebral bleeding within the last 2 months&#xD;
&#xD;
          -  acute infection&#xD;
&#xD;
          -  existing or planned pregnancy&#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>Ibrahim Akin, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>University Medical Center Mannheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Centre Mannheim</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Württemberg</state>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Behnes M, Akin I, Sartorius B, Fastner C, El-Battrawy I, Borggrefe M, Haubenreisser H, Meyer M, Schoenberg SO, Henzler T. --LAA Occluder View for post-implantation Evaluation (LOVE)--standardized imaging proposal evaluating implanted left atrial appendage occlusion devices by cardiac computed tomography. BMC Med Imaging. 2016 Mar 24;16:25. doi: 10.1186/s12880-016-0127-y.</citation>
    <PMID>27009279</PMID>
  </reference>
  <results_reference>
    <citation>Fastner C, Behnes M, Sartorius B, Yildiz M, Mashayekhi K, El-Battrawy I, Lehmann R, Baumann S, Becher T, Borggrefe M, Akin I. Left atrial appendage morphology, echocardiographic characterization, procedural data and in-hospital outcome of patients receiving left atrial appendage occlusion device implantation: a prospective observational study. BMC Cardiovasc Disord. 2016 Jan 28;16:25. doi: 10.1186/s12872-016-0200-z.</citation>
    <PMID>26822890</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>December 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 3, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>August 26, 2020</last_update_submitted>
  <last_update_submitted_qc>August 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitätsmedizin Mannheim</investigator_affiliation>
    <investigator_full_name>Michael Behnes</investigator_full_name>
    <investigator_title>Dr. med</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>
  <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/NCT02985463
org study id: 2014-402M-MA-§ 23b MPG
nct id: NCT02985463
lead sponsor: 
has dmc: No
"Left Atrial Appendage Occlusion and Biomarker Evaluation" (LABEL) is a single-center,
      prospective and observational study evaluating changes of the expression of biomarkers in
      eligible patients before and after percutaneous implantation of a left atrial appendage (LAA)
      occlusion device at mid-term follow-up.
This study will evaluate the changes of different types of biomarkers before and after
      successful percutaneous implantation of an LAA occlusion device.

      Biomarker evaluation will focus on blood derived biomarkers including neurohormones,
      proteins, cytokines, microRNAs and metabolomics.
observational model: Cohort
time perspective: Prospective
measure: Biomarker levels before successful LAA occlusion device implantation
time frame: 24 hours before intervention
measure: Biomarker levels after successful LAA occlusion device implantation
time frame: mid-term follow up at 6 months
measure: Changes of biomarker expression before and after device implantation over mid-term follow-up, depending of complete, incomplete occlusion, imaging data (transesophageal echocardiography, computed tomography)
time frame: mid-term follow up at 6 months
Two peripheral blood withdraws in EDTA, citrate, ammonium heparin, serum tubes 24 hours
      before and at mid-term follow up at 6 months after successful LAA occlusion device
      implantation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ibrahim Akin, Prof.
role: Study Director
affiliation: University Medical Center Mannheim
facility: 
country: Germany
citation: Behnes M, Akin I, Sartorius B, Fastner C, El-Battrawy I, Borggrefe M, Haubenreisser H, Meyer M, Schoenberg SO, Henzler T. --LAA Occluder View for post-implantation Evaluation (LOVE)--standardized imaging proposal evaluating implanted left atrial appendage occlusion devices by cardiac computed tomography. BMC Med Imaging. 2016 Mar 24;16:25. doi: 10.1186/s12880-016-0127-y.
PMID: 27009279
citation: Fastner C, Behnes M, Sartorius B, Yildiz M, Mashayekhi K, El-Battrawy I, Lehmann R, Baumann S, Becher T, Borggrefe M, Akin I. Left atrial appendage morphology, echocardiographic characterization, procedural data and in-hospital outcome of patients receiving left atrial appendage occlusion device implantation: a prospective observational study. BMC Cardiovasc Disord. 2016 Jan 28;16:25. doi: 10.1186/s12872-016-0200-z.
PMID: 26822890
responsible party type: Principal Investigator
investigator affiliation: Universitätsmedizin Mannheim
investigator full name: Michael Behnes
investigator title: Dr. med
mesh term: Atrial Fibrillation
sharing ipd: No