<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/NCT02199080</url>
  </required_header>
  <id_info>
    <org_study_id>2014/P02/001</org_study_id>
    <secondary_id>2013-A01700-45</secondary_id>
    <nct_id>NCT02199080</nct_id>
  </id_info>
  <brief_title>D-dimer Assay for the Exclusion of Intra-atrial Thrombus Risk Before Ablation of Atrial Fibrillation</brief_title>
  <official_title>Etude du Dosage Des d-dimères sériques Pour le Diagnostic d'Exclusion Des Thrombi Intra-atriaux Avant Ablation Endocavitaire de Fibrillation Atriale</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Hospitalier de la Rochelle Ré Aunis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Groupe Hospitalier de la Rochelle Ré Aunis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of&#xD;
      intraatrial thrombus before performing an ablation of atrial fibrillation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 28, 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound</measure>
    <time_frame>up to 48 hours before ablation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>CHADS2 Score</measure>
    <time_frame>48 hours before ablation</time_frame>
    <description>CHADS2 score (congestive heart failure=1, hypertension=1, diabetes mellitus=1, history of stroke or transient ischemic attack=1, and age under 75=1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk Factors</measure>
    <time_frame>48 hours before ablation</time_frame>
    <description>variables related to the presence of atrial thrombus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial Thrombus Exclusion (ATE) Score</measure>
    <time_frame>48 hours before ablation</time_frame>
    <description>The following thromboembolic risk factors mark 1 point if present in patient:&#xD;
hypertension = 1 point&#xD;
cardiac insufficiency = 1 point&#xD;
history of stoke = 1 point&#xD;
d-dimer level &gt;270ng/mL = 1 point The sum corresponds to the ATE score</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2506</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Atrial fibrillation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>D-dimer assay before ablation of atrial fibrillation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>D-dimer assay before ablation of atrial fibrillation</intervention_name>
    <description>Blood sample collection for D-dimers measurement</description>
    <arm_group_label>Atrial fibrillation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 18 years.&#xD;
&#xD;
          -  Patients hospitalized for ablation of atrial fibrillation or symptomatic left flutter&#xD;
&#xD;
          -  Patient informed of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years.&#xD;
&#xD;
          -  Patients under guardianship&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Contraindication to transesophageal echocardiography&#xD;
&#xD;
          -  transesophageal echocardiography made in another center as the center of ablation&#xD;
&#xD;
          -  Refusal of the patient to participate in the study&#xD;
&#xD;
          -  Patient participating in another interventional study in which an intervention related&#xD;
             to biomedical research is performed before the transesophageal echocardiography&#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>Antoine MILHEM, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Groupe Hospitalier de la Rochelle Ré Aunis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de cardiologie, CH de la Région d'Annecy</name>
      <address>
        <city>Annecy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier d' Auxerre</name>
      <address>
        <city>Auxerre</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CH Avignon</name>
      <address>
        <city>Avignon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique La Fourcade</name>
      <address>
        <city>Bayonne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHU Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHU Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHU Caen</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHU Clermont Ferrand</name>
      <address>
        <city>Clermont Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, AP Hôpital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHU Dijon</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier de la Rochelle Ré Aunis</name>
      <address>
        <city>La Rochelle</city>
        <zip>17019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CH Le Mans</name>
      <address>
        <city>Le Mans</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHU Limoges</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, HCL Groupement Est</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, APM Hôpital de La Timone</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHI Aix Pertuis CHPA-CHIAP</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, Hôpital Saint Joseph</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, Institut Jacques Cartier</name>
      <address>
        <city>Massy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHR Metz Thionville</name>
      <address>
        <city>Metz</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHI Le Raincy Montfermeil</name>
      <address>
        <city>Montfermeil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHU Nancy</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, Nouvelles Cliniques Nantaises</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHU Nîmes</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, HP Les Franciscaines</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, AP Hôpital la Pitié Salpêtrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, Groupe Hospitalier Bichat Claude Bernard</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CH Pau</name>
      <address>
        <city>Pau</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHU Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHU Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHU Rouen</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, Centre Cardiologique du Nord</name>
      <address>
        <city>Saint Denis</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHU Saint Etienne</name>
      <address>
        <city>Saint Etienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, CHU Toulouse Hôtel Dieu St Jacques</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, Clinique Saint Gatien</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, Clinique Saint Joseph</name>
      <address>
        <city>Trélaze</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de cardiologie, Polyclinique Vauban</name>
      <address>
        <city>Valenciennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <results_first_submitted>February 28, 2018</results_first_submitted>
  <results_first_submitted_qc>October 8, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 15, 2019</results_first_posted>
  <last_update_submitted>October 8, 2018</last_update_submitted>
  <last_update_submitted_qc>October 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrin fragment D</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Atrial Fibrillation</title>
          <description>D-dimer assay before ablation of atrial fibrillation&#xD;
D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2506"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2494"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Atrial Fibrillation</title>
          <description>D-dimer assay before ablation of atrial fibrillation&#xD;
D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2494"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.7" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="676"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1818"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2494"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Paroxysmal fibrillation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1335"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Persistent fibrillation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="996"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Left atrial tachycardia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>left ventricular ejection fraction</title>
          <units>percentage of ejection fraction</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.4" spread="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medical history</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Previous left atrial ablation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="593"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="916"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes mellitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="304"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Venous thromboembolism</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inflammatory disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neoplasia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infectious disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recent surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Anticoagulation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No anticoagulant therapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="235"/>
                  </measurement_list>
                </category>
                <category>
                  <title>DABIGATRAN</title>
                  <measurement_list>
                    <measurement group_id="B1" value="269"/>
                  </measurement_list>
                </category>
                <category>
                  <title>RIVAROXABAN</title>
                  <measurement_list>
                    <measurement group_id="B1" value="596"/>
                  </measurement_list>
                </category>
                <category>
                  <title>APIXABAN</title>
                  <measurement_list>
                    <measurement group_id="B1" value="321"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Effective Vitamin K antagonists</title>
                  <measurement_list>
                    <measurement group_id="B1" value="814"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non effective Vitamin K antagonists</title>
                  <measurement_list>
                    <measurement group_id="B1" value="245"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound</title>
        <time_frame>up to 48 hours before ablation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Atrial Fibrillation</title>
            <description>D-dimer assay before ablation of atrial fibrillation&#xD;
D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2494"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CHADS2 Score</title>
        <description>CHADS2 score (congestive heart failure=1, hypertension=1, diabetes mellitus=1, history of stroke or transient ischemic attack=1, and age under 75=1)</description>
        <time_frame>48 hours before ablation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Atrial Thrombus</title>
            <description>Patients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography</description>
          </group>
          <group group_id="O2">
            <title>No Atrial Thrombus</title>
            <description>Patients with no atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography</description>
          </group>
        </group_list>
        <measure>
          <title>CHADS2 Score</title>
          <description>CHADS2 score (congestive heart failure=1, hypertension=1, diabetes mellitus=1, history of stroke or transient ischemic attack=1, and age under 75=1)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="2446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>CHADS2 score = 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1277"/>
                  </measurement_list>
                </category>
                <category>
                  <title>CHADS2 score = 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="744"/>
                  </measurement_list>
                </category>
                <category>
                  <title>CHADS2 score = 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="299"/>
                  </measurement_list>
                </category>
                <category>
                  <title>CHADS2 score ≥ 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Risk Factors</title>
        <description>variables related to the presence of atrial thrombus</description>
        <time_frame>48 hours before ablation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Atrial Thrombus</title>
            <description>Patients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography</description>
          </group>
          <group group_id="O2">
            <title>No Atrial Thrombus</title>
            <description>Patients with no atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography</description>
          </group>
        </group_list>
        <measure>
          <title>Risk Factors</title>
          <description>variables related to the presence of atrial thrombus</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="2446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Age (≥ 75yrs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female gender</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistent fibrillation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="968"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="886"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes mellitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="285"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>History of stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Previous left atrial ablation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="584"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anticoagulation prior to ablation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="2212"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Atrial Thrombus Exclusion (ATE) Score</title>
        <description>The following thromboembolic risk factors mark 1 point if present in patient:&#xD;
hypertension = 1 point&#xD;
cardiac insufficiency = 1 point&#xD;
history of stoke = 1 point&#xD;
d-dimer level &gt;270ng/mL = 1 point The sum corresponds to the ATE score</description>
        <time_frame>48 hours before ablation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Atrial Thrombus</title>
            <description>Patients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography</description>
          </group>
          <group group_id="O2">
            <title>No Atrial Thrombus</title>
            <description>Patients with no atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography</description>
          </group>
        </group_list>
        <measure>
          <title>Atrial Thrombus Exclusion (ATE) Score</title>
          <description>The following thromboembolic risk factors mark 1 point if present in patient:&#xD;
hypertension = 1 point&#xD;
cardiac insufficiency = 1 point&#xD;
history of stoke = 1 point&#xD;
d-dimer level &gt;270ng/mL = 1 point The sum corresponds to the ATE score</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="2446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>ATE score = 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="911"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ATE score = 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="965"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ATE score = 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="467"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ATE score = 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ATE score = 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious and non-serious adverse events (biological and clinical) that occured between the signature of the consent and the end of patient participation were reported. The duration of patient participation was 48 hours.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Atrial Fibrillation</title>
          <description>D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2506"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2506"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2506"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Antoine Milhem</name_or_title>
      <organization>Groupe Hospitalier de la Rochelle Ré Aunis</organization>
      <phone>+33546455050</phone>
      <email>antoine.milhem@ch-larochelle.fr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02199080
org study id: 2014/P02/001
secondary id: 2013-A01700-45
nct id: NCT02199080
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of
      intraatrial thrombus before performing an ablation of atrial fibrillation
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound
time frame: up to 48 hours before ablation
measure: CHADS2 Score
time frame: 48 hours before ablation
description: CHADS2 score (congestive heart failure=1, hypertension=1, diabetes mellitus=1, history of stroke or transient ischemic attack=1, and age under 75=1)
measure: Risk Factors
time frame: 48 hours before ablation
description: variables related to the presence of atrial thrombus
measure: Atrial Thrombus Exclusion (ATE) Score
time frame: 48 hours before ablation
description: The following thromboembolic risk factors mark 1 point if present in patient:
hypertension = 1 point
cardiac insufficiency = 1 point
history of stoke = 1 point
d-dimer level >270ng/mL = 1 point The sum corresponds to the ATE score
arm group label: Atrial fibrillation
arm group type: Other
description: D-dimer assay before ablation of atrial fibrillation
intervention type: Other
intervention name: D-dimer assay before ablation of atrial fibrillation
description: Blood sample collection for D-dimers measurement
arm group label: Atrial fibrillation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antoine MILHEM, MD
role: Principal Investigator
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
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country: France
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Fibrin fragment D
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 