<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/NCT01673256</url>
  </required_header>
  <id_info>
    <org_study_id>DETECT AF</org_study_id>
    <nct_id>NCT01673256</nct_id>
  </id_info>
  <brief_title>DEtermining Accuracy and TrEnding CharacTerization of AF</brief_title>
  <official_title>DEtermining Accuracy and TrEnding CharacTerization of AF</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to assess the atrial fibrillation (AF) episode detection when&#xD;
      using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.</measure>
    <time_frame>4 days after Holter starts</time_frame>
    <description>Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM.&#xD;
Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>SJM Confirm ICM Observational Group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SJM Confirm ICM</intervention_name>
    <arm_group_label>SJM Confirm ICM Observational Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Care Clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject has been implanted with a SJM Confirm ICM, DM2102.&#xD;
&#xD;
          -  The subject has or is suspected to have paroxysmal AF.&#xD;
&#xD;
          -  The subject is ≥ 18 years of age.&#xD;
&#xD;
          -  The subject is willing and able to provide written Informed Consent (prior to any&#xD;
             investigational related procedure).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has persistent (&gt;7 days and ≤1 year or requiring cardioversion),&#xD;
             longstanding persistent (continuous AF &gt;1 year) or permanent AF (not attempting to&#xD;
             restore sinus rhythm).&#xD;
&#xD;
          -  The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid&#xD;
             disease).&#xD;
&#xD;
          -  The subject has a contraindication to Holter recording.&#xD;
&#xD;
          -  The subject has already received an active implantable medical device other than the&#xD;
             SJM Confirm ICM, DM2102.&#xD;
&#xD;
          -  The subject is unable to comply with the follow up schedule.&#xD;
&#xD;
          -  The subject is participating in another investigational device or drug investigation.&#xD;
&#xD;
          -  The subject is pregnant or is planning to become pregnant during the duration of the&#xD;
             investigation.&#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>Thorsten Lewalter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Isar Heart Center Munich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rhön-Klinikum, Herz- und Gefäß-Klinik</name>
      <address>
        <city>Bad Neustadt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz -und Diabeteszentrum</name>
      <address>
        <city>Bad Oeynhausen</city>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite, Campus Virchow-Klinikum</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Coburg</name>
      <address>
        <city>Coburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Dresden - Heart Center</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Frankfurt Höchst GmbH</name>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Ingolstadt GmbH</name>
      <address>
        <city>Ingolstadt</city>
        <zip>85049</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isar Heart Center</name>
      <address>
        <city>Munich</city>
        <zip>80331</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hegau-Bodensee-Kliniken</name>
      <address>
        <city>Singen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schwarzwald-Baar Klinikum GmbH</name>
      <address>
        <city>Villingen Schwenningen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hagahospital</name>
      <address>
        <city>Den Haag</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Schweitzer Hospital</name>
      <address>
        <city>Dordrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>January 5, 2015</results_first_submitted>
  <results_first_submitted_qc>March 16, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 18, 2015</results_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SJM Confirm ICM Observational Group</title>
          <description>SJM Confirm ICM</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SJM Confirm ICM Observational Group</title>
          <description>SJM Confirm ICM</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="90"/>
          </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="65.7" spread="9.6"/>
                  </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="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </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>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82.4" spread="16.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.</title>
        <description>Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM.&#xD;
Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor.</description>
        <time_frame>4 days after Holter starts</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SJM Confirm ICM Observational Group</title>
            <description>SJM Confirm ICM</description>
          </group>
        </group_list>
        <measure>
          <title>Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.</title>
          <description>Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM.&#xD;
Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor.</description>
          <units>percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Duration Sensitivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.9" lower_limit="71.6" upper_limit="96.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Duration Positive Predictive Value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" lower_limit="91.9" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>SJM Confirm ICM Observational Group</title>
          <description>SJM Confirm ICM</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
              </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="90"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kyle Brunner</name_or_title>
      <organization>St. Jude Medical Inc.</organization>
      <phone>651.756.3482</phone>
      <email>kbrunner02@sjm.com</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/NCT01673256
org study id: DETECT AF
nct id: NCT01673256
lead sponsor: 
has dmc: No
The objective of this study is to assess the atrial fibrillation (AF) episode detection when
      using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).
observational model: Cohort
time perspective: Prospective
measure: Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.
time frame: 4 days after Holter starts
description: Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM.
Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor.
arm group label: SJM Confirm ICM Observational Group
intervention type: Device
intervention name: SJM Confirm ICM
arm group label: SJM Confirm ICM Observational Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thorsten Lewalter, MD
role: Principal Investigator
affiliation: Isar Heart Center Munich
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Netherlands
responsible party type: Sponsor
mesh term: Atrial Fibrillation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 