<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/NCT01727297</url>
  </required_header>
  <id_info>
    <org_study_id>REVEAL AF</org_study_id>
    <nct_id>NCT01727297</nct_id>
  </id_info>
  <brief_title>REVEAL AF: Incidence of AF in High Risk Patients</brief_title>
  <official_title>REVEAL AF: Incidence of AF in High Risk Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Cardiac Rhythm and Heart Failure</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Cardiac Rhythm and Heart Failure</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to determine, through continuous monitoring with the Reveal implantable cardiac&#xD;
      monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be at high&#xD;
      risk for having AF and to understand how physicians manage these patients after AF has been&#xD;
      detected. This study will also seek to identify what patient characteristics are most&#xD;
      predictive of developing AF.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2012</start_date>
  <completion_date type="Actual">January 30, 2017</completion_date>
  <primary_completion_date type="Actual">January 13, 2017</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes</measure>
    <time_frame>Implant to 18 months post device insertion</time_frame>
    <description>Incidence of adjudicated AF lasting six or more minutes at 18 months. Each arrhythmic episode detected by the patient's Reveal device will be reviewed to determine if it is 1) an actual atrial fibrillation episode, and (2) is at least 6 minutes in duration. The first such episode per patient occurring within 18 months will be utilized to determine the 18 month incidence rate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Predictors of the Incidence of AF</measure>
    <time_frame>Time from implant to date of last stored available device data (maximum of 30 months)</time_frame>
    <description>AF will be defined as in the primary outcome. Baseline characteristics including demographics, medical history, and biomarkers at enrollment will be tested for their association with a patient's risk of developing AF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actions Taken in Response to Awareness of AF</measure>
    <time_frame>Time from first identified episode of AF to study exit (maximum of 30 months)</time_frame>
    <description>Clinical actions taken in response to clinician awareness of a patient's AF onset or progression will be summarized</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">446</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>REVEAL Implantable Cardiac Monitor</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>REVEAL Implantable Cardiac Monitor</intervention_name>
    <arm_group_label>REVEAL Implantable Cardiac Monitor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient meets the approved indications to receive the Reveal ICM&#xD;
&#xD;
          -  Patient is suspected, based on symptomatology and/or demographics, of having atrial&#xD;
             fibrillation or at high risk of having AF, as determined by the clinical investigator&#xD;
&#xD;
          -  Patient has a Congestive heart failure, Hypertension, Age ≥75 years, Diabetes&#xD;
             mellitus, prior Stroke or transient ischemic attack (TIA) or thromboembolism (doubled)&#xD;
             (CHADS2) score ≥ 3 OR has a CHADS2 score = 2 with at least one of the following&#xD;
             documented: renal impairment (GFR 30-60 ml/min), sleep apnea, coronary artery disease,&#xD;
             or chronic obstructive pulmonary disease. Note: stroke/TIA criterion as part of the&#xD;
             CHADS2 score for this trial is limited to either an ischemic stroke or TIA, which&#xD;
             occurred more than one year prior to enrollment.&#xD;
&#xD;
          -  Patient is 18 years of age or older&#xD;
&#xD;
          -  Patient has a life expectancy of 18 months or more&#xD;
&#xD;
          -  Patient, or legally authorized representative, is willing to sign and date the consent&#xD;
             form&#xD;
&#xD;
          -  Patient is willing and able to be remotely monitored (i.e., eligible for enrollment&#xD;
             into the Medtronic CareLink Network)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has a documented history of AF or atrial flutter&#xD;
&#xD;
          -  Patient had an ischemic stroke or TIA within past year prior to enrollment&#xD;
&#xD;
          -  Patient has a history of a hemorrhagic stroke&#xD;
&#xD;
          -  Patient is currently implanted with an implantable pulse generator (IPG), implantable&#xD;
             cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P),&#xD;
             or cardiac resynchronization therapy defibrillator (CRT-D) device&#xD;
&#xD;
          -  New York Heart Association (NYHA) Class IV Heart Failure patient&#xD;
&#xD;
          -  Patient had heart surgery within previous 90 days prior to enrollment&#xD;
&#xD;
          -  Patient had a myocardial infarction (MI) within the previous 90 days prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Patient is taking chronic immuno-suppressant therapy&#xD;
&#xD;
          -  Patient is taking an anti-arrhythmic drug&#xD;
&#xD;
          -  Patient is contraindicated for long term anticoagulation medication&#xD;
&#xD;
          -  Patient is taking a long-term anticoagulation medication&#xD;
&#xD;
          -  Any concomitant condition which, in the opinion of the investigator, would not allow&#xD;
             safe participation in the study (e.g., drug addiction, alcohol abuse, emotional /&#xD;
             psychological diagnosis)&#xD;
&#xD;
          -  Patient is enrolled in another study that could confound the results of this study,&#xD;
             without documented pre-approval from Medtronic study manager&#xD;
&#xD;
          -  Patient has a creatinine clearance &lt;30 ml/min or is on dialysis&#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>James A Reiffel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phoenix Heart, PLLC</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306-1870</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Consultants Heart Center</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720-3235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Heart Rhythm Consultants</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healdsburg Cardiology</name>
      <address>
        <city>Windsor</city>
        <state>California</state>
        <zip>95492</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanticoke Cardiology</name>
      <address>
        <city>Seaford</city>
        <state>Delaware</state>
        <zip>19973</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradenton Cardiology</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34205-8805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cardiac &amp; Vascular Institute</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605-4218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac Clinic</name>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <zip>34741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Georgia Heart Foundation</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501-3427</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier HealthCare</name>
      <address>
        <city>Bloomington</city>
        <state>Indiana</state>
        <zip>47403-3239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Consultants PC (Munster IN)</name>
      <address>
        <city>Munster</city>
        <state>Indiana</state>
        <zip>46321-4054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University Kansas Medical Center Research Institute Inc</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160-8500</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Consultants of Kansas</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delmarva Heart Research Foundation Inc</name>
      <address>
        <city>Salisbury</city>
        <state>Maryland</state>
        <zip>21804-6951</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Heart Institute Foundation</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407-1195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis VA Health Care System</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417-2309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Heart Clinic</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216-4634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis University Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110-2539</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cox Medical Center South</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807-5251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glacier View Research Institute Cardiology</name>
      <address>
        <city>Kalispell</city>
        <state>Montana</state>
        <zip>59901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Health Cardiology (Bergen)</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68124-2319</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Englewood Hospital &amp; Medical Center</name>
      <address>
        <city>Englewood</city>
        <state>New Jersey</state>
        <zip>07631-1808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Valley Hospital</name>
      <address>
        <city>Ridgewood</city>
        <state>New Jersey</state>
        <zip>07450-2726</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lourdes Cardiology Services</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029-6574</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York-Presbyterian Hospital/Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032-3725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caromont Regional Medical Center</name>
      <address>
        <city>Gastonia</city>
        <state>North Carolina</state>
        <zip>28054-2140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Elizabeth Youngstown Hospital</name>
      <address>
        <city>Youngstown</city>
        <state>Ohio</state>
        <zip>44504-1006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Heart Hospital Research Foundation</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salem Cardiovascular Associates</name>
      <address>
        <city>Salem</city>
        <state>Oregon</state>
        <zip>97302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Heart Care Group PC (Allentown PA)</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103-6202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau Institute for Medical Research</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096-3450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South County Cardiology</name>
      <address>
        <city>Wakefield</city>
        <state>Rhode Island</state>
        <zip>02879-4253</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Selcuk A. Tombul, D.O., F.A.C.C.</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Stern Cardiovascular Foundation</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138-1727</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sutherland Cardiology Clinic</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138-1760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turkey Creek Medical Center</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37934</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Heart &amp; Vascular Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75226-1301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Research Institute (Plano TX)</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093-3691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woodlands North Houston Heart and Vein Center</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77384-4167</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProHealth Care</name>
      <address>
        <city>Waukesha</city>
        <state>Wisconsin</state>
        <zip>53188</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH - Universitätsklinikum Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allgemein öffentliches Krankenhaus der Elisabethinen Linz</name>
      <address>
        <city>Linz</city>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Coburg GmbH</name>
      <address>
        <city>Coburg</city>
        <zip>96450</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Göttingen Georg-August-Universität</name>
      <address>
        <city>Gottingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Sankt Georg</name>
      <address>
        <city>Hamburg</city>
        <zip>20099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Lünen St.-Marien-Hospital GmbH - Akademisches Lehrkrankenhaus der Westfälischen Wilhelms-Un</name>
      <address>
        <city>Lünen</city>
        <zip>44534</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Gerardo</name>
      <address>
        <city>Monza</city>
        <zip>20090</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale classificato ed equiparato Sacro Cuore - Don Calabria</name>
      <address>
        <city>Negrar</city>
        <zip>37024</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale civile di Ciriè</name>
      <address>
        <city>Torino</city>
        <zip>10073</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catharina Ziekenhuis</name>
      <address>
        <city>Eindhoven</city>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3430 EM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Centre Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Tarragona Joan XXIII</name>
      <address>
        <city>Tarragona</city>
        <zip>43007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <results_first_submitted>December 13, 2017</results_first_submitted>
  <results_first_submitted_qc>February 28, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 29, 2018</results_first_posted>
  <last_update_submitted>March 29, 2018</last_update_submitted>
  <last_update_submitted_qc>March 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2018</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Patients in the 'No Reveal Implantable Cardiac Monitor Implant Attempt' arm were exited from the study prior to an implant attempt. Therefore, no outcome data are available. Baseline data are not presented due to variable data collection before the time of exit. Adverse event data were collected for this cohort, and are reported below.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Reveal Implantable Cardiac Monitor Implant Attempted</title>
          <description>Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted)</description>
        </group>
        <group group_id="P2">
          <title>No Reveal Implantable Cardiac Monitor Implant Attempt</title>
          <description>Enrolled subjects who exited the study prior to undergoing a procedure to implant a Reveal Implantable Cardiac Monitor</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="395"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="293"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other (e.g. AF detection pre-implant)</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Reveal Implantable Cardiac Monitor Implant Attempted</title>
          <description>Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="395"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="307"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="71.6" spread="9.8"/>
                  </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="188"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="207"/>
                  </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>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="302"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes</title>
        <description>Incidence of adjudicated AF lasting six or more minutes at 18 months. Each arrhythmic episode detected by the patient's Reveal device will be reviewed to determine if it is 1) an actual atrial fibrillation episode, and (2) is at least 6 minutes in duration. The first such episode per patient occurring within 18 months will be utilized to determine the 18 month incidence rate.</description>
        <time_frame>Implant to 18 months post device insertion</time_frame>
        <population>This analysis only included patients who received an implantable cardiac monitor, met all inclusion/exclusion criteria, and had device data available. Of the 395 participants who underwent an implant attempt, 1 attempt was unsuccessful, 7 subjects did not meet all inclusion/exclusion criteria, and 2 subjects had no post-implant device data.</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Objective Analysis Cohort</title>
            <description>Subjects successfully implanted with a Reveal Implantable Cardiac Monitor (ICM), who also (1) have post-implant device data to evaluate, (2) were not on anti-arrhythmic medication at enrollment, (3) did not have AF prior to Reveal ICM implant, and (4) satisfy the Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, prior Stroke or transient ischemic attack (TIA) or thromboembolism (doubled) (CHADS2) inclusion criteria for the study (CHADS2 score of 3 or higher, or a CHADS2 score of 2 along with chronic obstructive pulmonary disease, sleep apnea, renal impairment, or coronary artery disease)</description>
          </group>
        </group_list>
        <measure>
          <title>18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes</title>
          <description>Incidence of adjudicated AF lasting six or more minutes at 18 months. Each arrhythmic episode detected by the patient's Reveal device will be reviewed to determine if it is 1) an actual atrial fibrillation episode, and (2) is at least 6 minutes in duration. The first such episode per patient occurring within 18 months will be utilized to determine the 18 month incidence rate.</description>
          <population>This analysis only included patients who received an implantable cardiac monitor, met all inclusion/exclusion criteria, and had device data available. Of the 395 participants who underwent an implant attempt, 1 attempt was unsuccessful, 7 subjects did not meet all inclusion/exclusion criteria, and 2 subjects had no post-implant device data.</population>
          <units>percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="385"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Predictors of the Incidence of AF</title>
        <description>AF will be defined as in the primary outcome. Baseline characteristics including demographics, medical history, and biomarkers at enrollment will be tested for their association with a patient's risk of developing AF.</description>
        <time_frame>Time from implant to date of last stored available device data (maximum of 30 months)</time_frame>
        <population>This analysis only included patients who received an implantable cardiac monitor, were not on antiarrhythmic medications at baseline, and had device data available. Of the 395 participants who underwent an implant attempt, 1 attempt was unsuccessful, 1 subject was on antiarrhythmic medication, and 2 subjects had no post-implant device data.</population>
        <group_list>
          <group group_id="O1">
            <title>AF Predictors Analysis Cohort: AF Episodes</title>
            <description>Subjects successfully implanted with a Reveal Implantable Cardiac Monitor (ICM), and who (1) have post-implant ICM device data to evaluate, (2) were not on anti-arrhythmic medication at enrollment, (3) did not have AF prior to Reveal implant, and (4) experienced an AF episode lasting at least 6 minutes during follow-up.</description>
          </group>
          <group group_id="O2">
            <title>AF Predictors Analysis Cohort: No AF Episodes</title>
            <description>Subjects successfully implanted with a Reveal Implantable Cardiac Monitor (ICM), and who (1) have post-implant ICM device data to evaluate, (2) were not on anti-arrhythmic medication at enrollment, (3) did not have AF prior to Reveal implant, and (4) did not experience an AF episode lasting at least 6 minutes during follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Predictors of the Incidence of AF</title>
          <description>AF will be defined as in the primary outcome. Baseline characteristics including demographics, medical history, and biomarkers at enrollment will be tested for their association with a patient's risk of developing AF.</description>
          <population>This analysis only included patients who received an implantable cardiac monitor, were not on antiarrhythmic medications at baseline, and had device data available. Of the 395 participants who underwent an implant attempt, 1 attempt was unsuccessful, 1 subject was on antiarrhythmic medication, and 2 subjects had no post-implant device data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="261"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Gender (Male)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                    <measurement group_id="O2" value="244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal impairment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chronic obstructive pulmonary disorder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prior stroke &gt; 1 year ago</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coronary artery disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep apnea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family history of AF</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vascular disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that age did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. Age was treated as a continuous variable in years.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.05</ci_lower_limit>
            <ci_upper_limit>1.11</ci_upper_limit>
            <estimate_desc>The hazard ratio represented the effect of a one year increase in age on a patient's risk of developing AF. Descriptive statistics (mean±standard deviation) for age were 75.7±7.9 years among patients with AF, and 69.4±10.0 among patients without AF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that body mass index (BMI) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.02</p_value>
            <p_value_desc>All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. BMI was treated as a continuous variable.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.01</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
            <estimate_desc>The hazard ratio represented the effect of a one unit increase in BMI on a patient's risk of developing AF. Descriptive statistics (mean ± standard deviation) for BMI were 31.0 ± 6.6 among patients with AF, and 31.2 ± 6.4 among patients without AF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that gender did not influence a patient's risk of experiencing AF (it's coefficient for being male in a Cox proportional hazards model was 0).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.56</p_value>
            <p_value_desc>All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>1.61</ci_upper_limit>
            <estimate_desc>The hazard ratio represented the effect of being male on a patient's risk of developing AF.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that diabetes did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.66</p_value>
            <p_value_desc>All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>1.59</ci_upper_limit>
            <estimate_desc>The hazard ratio represented the effect of having diabetes on a patient's risk of developing AF.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that heart failure did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.73</p_value>
            <p_value_desc>All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.69</ci_upper_limit>
            <estimate_desc>The hazard ratio represented the effect of having heart failure on a patient's risk of developing AF.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that hypertension did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.58</p_value>
            <p_value_desc>All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>2.60</ci_upper_limit>
            <estimate_desc>The hazard ratio represented the effect of having hypertension on a patient's risk of developing AF.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that renal impairment did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.65</p_value>
            <p_value_desc>All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>1.32</ci_upper_limit>
            <estimate_desc>The hazard ratio represented the effect of having renal impairment on a patient's risk of developing AF.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that Chronic obstructive pulmonary disease (COPD) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.22</p_value>
            <p_value_desc>All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>1.20</ci_upper_limit>
            <estimate_desc>The hazard ratio represented the effect of having COPD on a patient's risk of developing AF.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that prior stroke more than one year pre-device implant did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.53</p_value>
            <p_value_desc>All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.54</ci_lower_limit>
            <ci_upper_limit>1.38</ci_upper_limit>
            <estimate_desc>The hazard ratio represented the effect of having a prior stroke (more than one year pre-device implant) on a patient's risk of developing AF.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that coronary artery disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.21</p_value>
            <p_value_desc>All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
            <estimate_desc>The hazard ratio represented the effect of having coronary artery disease on a patient's risk of developing AF.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that sleep apnea did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.19</p_value>
            <p_value_desc>All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
            <estimate_desc>The hazard ratio represented the effect of having sleep apnea on a patient's risk of developing AF.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that family history of AF did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.16</p_value>
            <p_value_desc>All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>5.14</ci_upper_limit>
            <estimate_desc>The hazard ratio represented the effect of having a family history of AF on a patient's risk of developing AF.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that vascular disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.63</p_value>
            <p_value_desc>All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.56</ci_lower_limit>
            <ci_upper_limit>1.43</ci_upper_limit>
            <estimate_desc>The hazard ratio represented the effect of having vascular disease on a patient's risk of developing AF.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Actions Taken in Response to Awareness of AF</title>
        <description>Clinical actions taken in response to clinician awareness of a patient's AF onset or progression will be summarized</description>
        <time_frame>Time from first identified episode of AF to study exit (maximum of 30 months)</time_frame>
        <population>Each visit represents the number of subjects who had a 1st, 2nd, 3rd visit, etc. in which AF was identified by the physician. Subjects in the &quot;Sixth Visit with AF Detected&quot; column had 6 visits in which AF was detected by the physician, and the column reflects the actions taken at that sixth visit.</population>
        <group_list>
          <group group_id="O1">
            <title>First Visit With AF Detected</title>
            <description>Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:&#xD;
Did not have diagnosed AF prior to implant,&#xD;
met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),&#xD;
was not taking an anti-arrhythmic drug at enrollment, and&#xD;
Had a follow-up visit in which new AF episodes were diagnosed</description>
          </group>
          <group group_id="O2">
            <title>Second Visit With AF Detected</title>
            <description>Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:&#xD;
Did not have diagnosed AF prior to implant,&#xD;
met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),&#xD;
was not taking an anti-arrhythmic drug at enrollment, and&#xD;
Had a 2nd follow-up visit in which new AF episodes were diagnosed</description>
          </group>
          <group group_id="O3">
            <title>Third Visit With AF Detected</title>
            <description>Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:&#xD;
Did not have diagnosed AF prior to implant,&#xD;
met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),&#xD;
was not taking an anti-arrhythmic drug at enrollment, and&#xD;
Had a 3rd follow-up visit in which new AF episodes were diagnosed</description>
          </group>
          <group group_id="O4">
            <title>Fourth Visit With AF Detected</title>
            <description>Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:&#xD;
Did not have diagnosed AF prior to implant,&#xD;
met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),&#xD;
was not taking an anti-arrhythmic drug at enrollment, and&#xD;
Had a 4th follow-up visit in which new AF episodes were diagnosed</description>
          </group>
          <group group_id="O5">
            <title>Fifth Visit With AF Detected</title>
            <description>Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:&#xD;
Did not have diagnosed AF prior to implant,&#xD;
met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),&#xD;
was not taking an anti-arrhythmic drug at enrollment, and&#xD;
Had a 5th follow-up visit in which new AF episodes were diagnosed</description>
          </group>
          <group group_id="O6">
            <title>Sixth Visit With AF Detected</title>
            <description>Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:&#xD;
Did not have diagnosed AF prior to implant,&#xD;
met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease),&#xD;
was not taking an anti-arrhythmic drug at enrollment, and&#xD;
Had a 6th follow-up visit in which new AF episodes were diagnosed</description>
          </group>
        </group_list>
        <measure>
          <title>Actions Taken in Response to Awareness of AF</title>
          <description>Clinical actions taken in response to clinician awareness of a patient's AF onset or progression will be summarized</description>
          <population>Each visit represents the number of subjects who had a 1st, 2nd, 3rd visit, etc. in which AF was identified by the physician. Subjects in the &quot;Sixth Visit with AF Detected&quot; column had 6 visits in which AF was detected by the physician, and the column reflects the actions taken at that sixth visit.</population>
          <units>Actions at Visits</units>
          <param>Count of Units</param>
          <units_analyzed>Actions at Visits</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="115"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="6"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Actions at Visits</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="2"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Oral Anticoagulation Initiated</title>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rhythm Control Medication Initiated</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rate Control Medication Initiated</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cardioversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ablation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Referral to Another Physician</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events occurring from the time of enrollment (consent) until exit will be included. All subjects were to be followed a minimum of 18 months and a maximum of 30 months post-Reveal device implantation.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Reveal Implantable Cardiac Monitor Implant Attempted</title>
          <description>Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted)</description>
        </group>
        <group group_id="E2">
          <title>No Reveal Implantable Cardiac Monitor Implant Attempt</title>
          <description>Enrolled subjects who exited the study prior to undergoing a procedure to implant a Reveal Implantable Cardiac Monitor</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MeDRA Preferred Term</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="395"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="153" subjects_at_risk="395"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Sinus arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Oesophageal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Rectal polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="15" subjects_affected="11" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Implant site pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Medical device site erosion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Lead dislodgement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Oversensing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Implant site infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Incisional hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Postoperative fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute promyelocytic leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Brain neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Bronchial carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Chronic lymphocytic leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Basal ganglia stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Central nervous system inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Hepatic encephalopathy</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Hypertensive encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Partial seizures</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Sensory disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Completed suicide</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Acute prerenal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="395"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MeDRA Preferred Term</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="395"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="36" subjects_affected="34" subjects_at_risk="395"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </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>Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and participating institutions will provide any publication of study data generated by the Investigator and/or participating institution to Medtronic for review prior to submission to determine if confidential information (&quot;CI&quot;) is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medtronic Cardiac Rhythm and Heart Failure clinical trial manager</name_or_title>
      <organization>Medtronic, Inc.</organization>
      <phone>763-505-6000</phone>
      <email>medtronicCRMtrials@medtronic.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/NCT01727297
org study id: REVEAL AF
nct id: NCT01727297
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study is to determine, through continuous monitoring with the Reveal implantable cardiac
      monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be at high
      risk for having AF and to understand how physicians manage these patients after AF has been
      detected. This study will also seek to identify what patient characteristics are most
      predictive of developing AF.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: 18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes
time frame: Implant to 18 months post device insertion
description: Incidence of adjudicated AF lasting six or more minutes at 18 months. Each arrhythmic episode detected by the patient's Reveal device will be reviewed to determine if it is 1) an actual atrial fibrillation episode, and (2) is at least 6 minutes in duration. The first such episode per patient occurring within 18 months will be utilized to determine the 18 month incidence rate.
measure: Predictors of the Incidence of AF
time frame: Time from implant to date of last stored available device data (maximum of 30 months)
description: AF will be defined as in the primary outcome. Baseline characteristics including demographics, medical history, and biomarkers at enrollment will be tested for their association with a patient's risk of developing AF.
measure: Actions Taken in Response to Awareness of AF
time frame: Time from first identified episode of AF to study exit (maximum of 30 months)
description: Clinical actions taken in response to clinician awareness of a patient's AF onset or progression will be summarized
arm group label: REVEAL Implantable Cardiac Monitor
arm group type: Other
intervention type: Device
intervention name: REVEAL Implantable Cardiac Monitor
arm group label: REVEAL Implantable Cardiac Monitor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James A Reiffel, MD
role: Principal Investigator
affiliation: Columbia University
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country: Austria
country: Germany
country: Italy
country: Netherlands
country: Slovenia
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No
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