<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/NCT01678456</url>
  </required_header>
  <id_info>
    <org_study_id>AFNET_A7</org_study_id>
    <nct_id>NCT01678456</nct_id>
  </id_info>
  <brief_title>Prospective Registration and Assessment of Serious Adverse Events Within the AFNET</brief_title>
  <acronym>AFNET A7</acronym>
  <official_title>Prospective Registration and Independent Assessment of Incidence, Clinical Relevance and Outcome of Serious Adverse Events (SAE) Registered in the German Competence Network on Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Atrial Fibrillation Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Atrial Fibrillation Network</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>
      Prospective registration and independent assessment of SAE associated with atrial&#xD;
      fibrillation such as thromboembolic events, and other cardiac and noncardiac complications by&#xD;
      a Critical Event Committee.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atrial fibrillation (AF), the most common sustained rhythm disturbance, is associated with a&#xD;
      significantly enhanced mortality and morbidity due to thromboembolic events, and other&#xD;
      cardiac and noncardiac complications. Therefore the &quot;Network of Competence on Atrial&#xD;
      Fibrillation (AFNET)&quot; supported by the German Ministry for Education and Research (BMBF) was&#xD;
      established in order to collect clinical data on patients (pts) with AF (paroxysmal,&#xD;
      persistent, permanent) over a study period of 6 years with an expected sample size of 12,000&#xD;
      pts. Incidence, clinical relevance and outcome after SAE is recorded and assessed by a&#xD;
      Critical Event Committee (CEC).&#xD;
&#xD;
      The CEC-members (experts in cardiology and neurology) defined as SAE any death with or&#xD;
      without relationship to AF, cardio-embolic events (stroke, peripheral arterial embolism),&#xD;
      bleeding complications due to antithrombotic therapy, acute heart failure, syncope,&#xD;
      resuscitation; additionally, the complication of interventional strategies for AF-treatment&#xD;
      and other AF-independent SAEs.&#xD;
&#xD;
      Over a 3-year follow-up period, during 6-monthly and unscheduled visits, the SAEs are&#xD;
      systematically documented, blinded and their relationship to AF will be interpreted in detail&#xD;
      by the CEC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2004</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</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>
  <enrollment type="Actual">13000</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Assessment of Serious Advers Events</condition>
  <condition>Thromboembolic and Bleeding Complications</condition>
  <condition>Complications of Antiarrhythmic Drugs or Invasive Procedures</condition>
  <condition>Assessment by a Critical Event Committee</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Real-life population Patients with atrial fibrilation documented within the last 12 months&#xD;
        before enrollment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Atrial fibrillation documented by ECG not older then one year&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Informed consent&#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>Michael Oeff, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>SAE-Zentrum Brandenburg/Havel Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Staedt. Klinikum, Department of Cardiology</name>
      <address>
        <city>Brandenburg</city>
        <zip>14770</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>September 14, 2005</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>September 18, 2020</last_update_submitted>
  <last_update_submitted_qc>September 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Critical Event Committee</keyword>
  <keyword>Serious adverse events</keyword>
  <keyword>Thromboembolic complications</keyword>
  <keyword>Cardiac and noncardiac complications</keyword>
  <keyword>Bleeding complications</keyword>
  <keyword>Acute heart failure</keyword>
  <keyword>Syncope</keyword>
  <keyword>Resuscitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Hemorrhage</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/NCT01678456
org study id: AFNET_A7
nct id: NCT01678456
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective registration and independent assessment of SAE associated with atrial
      fibrillation such as thromboembolic events, and other cardiac and noncardiac complications by
      a Critical Event Committee.
Atrial fibrillation (AF), the most common sustained rhythm disturbance, is associated with a
      significantly enhanced mortality and morbidity due to thromboembolic events, and other
      cardiac and noncardiac complications. Therefore the "Network of Competence on Atrial
      Fibrillation (AFNET)" supported by the German Ministry for Education and Research (BMBF) was
      established in order to collect clinical data on patients (pts) with AF (paroxysmal,
      persistent, permanent) over a study period of 6 years with an expected sample size of 12,000
      pts. Incidence, clinical relevance and outcome after SAE is recorded and assessed by a
      Critical Event Committee (CEC).

      The CEC-members (experts in cardiology and neurology) defined as SAE any death with or
      without relationship to AF, cardio-embolic events (stroke, peripheral arterial embolism),
      bleeding complications due to antithrombotic therapy, acute heart failure, syncope,
      resuscitation; additionally, the complication of interventional strategies for AF-treatment
      and other AF-independent SAEs.

      Over a 3-year follow-up period, during 6-monthly and unscheduled visits, the SAEs are
      systematically documented, blinded and their relationship to AF will be interpreted in detail
      by the CEC.
observational model: Cohort
time perspective: Prospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Oeff, Professor
role: Principal Investigator
affiliation: SAE-Zentrum Brandenburg/Havel Germany
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Hemorrhage