xml: <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/NCT05995561</url>
    </required_header>
    <id_info>
      <org_study_id>HERA AFIb registry</org_study_id>
      <nct_id>NCT05995561</nct_id>
    </id_info>
    <brief_title>HERA AFIb Registry for Patients With Atrial Fibrillation</brief_title>
    <official_title>HERA AFIb Registry</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Heidelberg</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital Heidelberg</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 single-center HERA AFIb registry was created to assess real-world prevalence, demographic&#xD;
        characteristics and management of patients with atrial fibrillation (AF) in the era of novel&#xD;
        oral anticoagulant regimes (NOAC) presenting in the emergency department (ED) of University&#xD;
        of Heidelberg&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        HERA AFIb is a single-center retrospective registry which enrolled consecutive cases&#xD;
        presenting with atrial fibrillation at the emergency department of University Hospital of&#xD;
        Heidelberg. Clinical parameters and characteristics for cases were assessed retrospectively.&#xD;
        Follow-up was performed via review of medical reports, phone calls and postal queries.&#xD;
        Outcome parameters included rates for all-cause mortality, non-hemorrhagic stroke, myocardial&#xD;
        infarction and major bleeding.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2009</start_date>
    <completion_date type="Actual">April 1, 2020</completion_date>
    <primary_completion_date type="Actual">April 1, 2020</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>all-cause mortality</measure>
      <time_frame>24 months</time_frame>
      <description>all-cause mortality during follow-up</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ischaemic stroke</measure>
      <time_frame>24 months</time_frame>
      <description>ischaemic stroke during follow-up</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>major bleeding</measure>
      <time_frame>24 months</time_frame>
      <description>major bleeding during follow-up</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>myocardial infarction</measure>
      <time_frame>24 months</time_frame>
      <description>myocardial infarction during follow-up</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">12297</enrollment>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>atrial fibrillation</arm_group_label>
      <description>cases presenting with atrial fibrillation at the emegency department.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>no intervention is planned.</intervention_name>
      <description>no intervention is planned.</description>
      <arm_group_label>atrial fibrillation</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          A cohort of approximately 13000 consecutive patients with atrial fibrillation presenting to&#xD;
          the emergency department of the Heidelberg University Hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  documented atrial fibrillation&#xD;
  &#xD;
            -  availability of at least one hsTnT measurement&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  lost to follow-up&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University Hospital of Heidelberg</name>
        <address>
          <city>Heidelberg</city>
          <state>Baden-Württemberg</state>
          <zip>69120</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital Heidelberg</investigator_affiliation>
      <investigator_full_name>Mustafa Yildirim</investigator_full_name>
      <investigator_title>Principle investigator</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>
  
  
text: 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/NCT05995561
  org study id: HERA AFIb registry
  nct id: NCT05995561
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The single-center HERA AFIb registry was created to assess real-world prevalence, demographic
        characteristics and management of patients with atrial fibrillation (AF) in the era of novel
        oral anticoagulant regimes (NOAC) presenting in the emergency department (ED) of University
        of Heidelberg
  HERA AFIb is a single-center retrospective registry which enrolled consecutive cases
        presenting with atrial fibrillation at the emergency department of University Hospital of
        Heidelberg. Clinical parameters and characteristics for cases were assessed retrospectively.
        Follow-up was performed via review of medical reports, phone calls and postal queries.
        Outcome parameters included rates for all-cause mortality, non-hemorrhagic stroke, myocardial
        infarction and major bleeding.
  observational model: Other
  time perspective: Retrospective
  measure: all-cause mortality
  time frame: 24 months
  description: all-cause mortality during follow-up
  measure: ischaemic stroke
  time frame: 24 months
  description: ischaemic stroke during follow-up
  measure: major bleeding
  time frame: 24 months
  description: major bleeding during follow-up
  measure: myocardial infarction
  time frame: 24 months
  description: myocardial infarction during follow-up
  arm group label: atrial fibrillation
  description: cases presenting with atrial fibrillation at the emegency department.
  intervention type: Other
  intervention name: no intervention is planned.
  description: no intervention is planned.
  arm group label: atrial fibrillation
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Germany
  responsible party type: Principal Investigator
  investigator affiliation: University Hospital Heidelberg
  investigator full name: Mustafa Yildirim
  investigator title: Principle investigator
  mesh term: Atrial Fibrillation
  sharing ipd: No