<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/NCT01706146</url>
  </required_header>
  <id_info>
    <org_study_id>STU00064217</org_study_id>
    <secondary_id>1R34HL113404-01</secondary_id>
    <secondary_id>7R34HL113404-03</secondary_id>
    <nct_id>NCT01706146</nct_id>
  </id_info>
  <brief_title>Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring</brief_title>
  <acronym>REACT COM</acronym>
  <official_title>Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atrial fibrillation (AF) is the most common sustained abnormal rhythm of the heart, affects&#xD;
      an estimated 2.5 to 5 million individuals in the US, and can lead to stroke, heart failure,&#xD;
      and premature death. For those with AF and other stroke risk factors, chronic anticoagulation&#xD;
      is recommended to prevent intracardiac thrombus formation and stroke even if the AF is&#xD;
      infrequent or short-lived. This standard of care is based partly on our inability to rapidly&#xD;
      recognize and respond to AF recurrences which can often be brief and asymptomatic, but&#xD;
      exposes the patient to the risk of anticoagulant-induced hemorrhage even during prolonged&#xD;
      periods of sinus rhythm where the risk of stroke is presumably low.&#xD;
&#xD;
      Recent advances in device technology and drug therapy, however, have the potential to change&#xD;
      the way the investigators manage AF. The use of a small leadless subcutaneous implantable&#xD;
      cardiac monitor with remote data transmission capabilities (Reveal XT, Medtronic Inc.)&#xD;
      provides the ability to remotely and continuously evaluate a patient for AF recurrences, even&#xD;
      episodes that are brief and asymptomatic. In addition, release of unique oral thrombin&#xD;
      inhibitor approved for use in non-valvular AF(Dabigatran [Pradaxa], Rivaroxaban [Xarelto])&#xD;
      allows for rapid onset anticoagulation within minutes to hours of a single oral dose.&#xD;
      Together, these advances allow for continuous AF monitoring with targeted anticoagulation&#xD;
      only around the time of an AF episode, thereby reducing the risk of drug-induced hemorrhage&#xD;
      while still protecting against stroke.&#xD;
&#xD;
      The aim of this pilot study is to assess the feasibility of intermittent anticoagulation with&#xD;
      a rapid-onset oral thrombin inhibitor guided by a continuous AF-sensing implantable cardiac&#xD;
      monitor (Reveal XT) with remote data transmission capabilities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Days on Anticoagulation</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Assess subject anticoagulant utilization and number of days on anticoagulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleeding Incidence</measure>
    <time_frame>up to 12 months</time_frame>
    <description>To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Stroke Rate</measure>
    <time_frame>12 months</time_frame>
    <description>To assess the stroke rate with implantable monitor-guided intermittent anticoagulation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Overall Survival</measure>
    <time_frame>12 months</time_frame>
    <description>To assess the overall survival rate with implantable monitor-guided intermittent anticoagulation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Major Bleeding-free Survival Rate</measure>
    <time_frame>12 months</time_frame>
    <description>To assess the major bleeding-free survival rate with implantable monitor-guided intermittent anticoagulation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Stroke-free Survival Rate</measure>
    <time_frame>12 months</time_frame>
    <description>To assess the stroke-free survival rate with implantable monitor-guided intermittent anticoagulation.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Non-Coumadin Oral Anticoagulant</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Non-coumadin Oral Anticoagulant</intervention_name>
    <description>Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.</description>
    <arm_group_label>Non-Coumadin Oral Anticoagulant</arm_group_label>
    <other_name>Including but not limited to:</other_name>
    <other_name>Dabigatran (Pradaxa)</other_name>
    <other_name>Rivaroxaban (Xarelto)</other_name>
    <other_name>Apixaban (Eliquis)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients must meet all of the following criteria:&#xD;
&#xD;
          1. Age 18 and above.&#xD;
&#xD;
          2. Patients with non-valvular, non-continuous AF and either:&#xD;
&#xD;
             (A) Infrequent AF episodes without a rhythm control strategy who have had no&#xD;
             documented AF lasting &gt; 1 hour for 3 consecutive months (the last 2 of which are on a&#xD;
             previously implanted Reveal XT implantable cardiac monitor), or (B) Previous or&#xD;
             current rhythm control strategy. Rhythm control strategies may include: i. Class I or&#xD;
             Class III antiarrhythmic drugs ii. Pulmonary vein isolation iii. Post-MAZE/minimally&#xD;
             invasive MAZE&#xD;
&#xD;
          3. Current Reveal XT implant prior to study enrollment.&#xD;
&#xD;
          4. Documented clinical history of symptomatic or asymptomatic paroxysmal, long-standing&#xD;
             persistent or persistent AF prior to rhythm control initiation. The duration of AF&#xD;
             must have been &gt; 30 seconds as documented by an external monitor, present 12 lead ECG,&#xD;
             or Reveal XT.&#xD;
&#xD;
          5. CHADS2 score of 1 or 2&#xD;
&#xD;
          6. Candidates for chronic anticoagulation with an FDA-approved non-Coumadin oral&#xD;
             anticoagulant (dabigatran, rivaroxaban, apixaban), based on the discretion of the&#xD;
             treating physician.&#xD;
&#xD;
          7. Demonstrated ability to tolerate dabigatran 150mg/BID (if CrCl &gt;30ml/min), rivaroxaban&#xD;
             15mg QD (if CrCl 15-49 ml/min) and 20mg QD (if CrCl ≥50ml/min), or apixaban 5mg BID or&#xD;
             2.5 mg for subjects with ≥2 of the following: age ≥ 80 years, body weight ≤60kg, serum&#xD;
             creatinine ≥1.5 mg/dl.&#xD;
&#xD;
          8. Able and willing to provide written informed consent and willing to follow&#xD;
             instructions, attend all required study visits, and undergo all planned tests.&#xD;
&#xD;
          9. Subject must be willing and able to discontinue oral anticoagulation for the purposes&#xD;
             of this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients should not have any of the following criteria:&#xD;
&#xD;
          1. Permanent AF&#xD;
&#xD;
          2. Any documented single AF episode lasting ≥ 1 hour per month over two consecutive&#xD;
             months prior to study enrollment.&#xD;
&#xD;
             Mechanical prosthetic valves or severe valve disease.&#xD;
&#xD;
          3. CHADS2 score of 0, or &gt; 2&#xD;
&#xD;
          4. Subject deemed high risk for non-cardioembolic stroke (i.e. significant carotid artery&#xD;
             disease) based on discretion of the investigator.&#xD;
&#xD;
          5. Individual is pregnant, nursing, or planning to become pregnant.&#xD;
&#xD;
          6. Known hypersensitivity to non-Coumadin oral anticoagulants.&#xD;
&#xD;
          7. Documented prior stroke or transient ischemic attack.&#xD;
&#xD;
          8. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated&#xD;
             hyperthyroidism).&#xD;
&#xD;
          9. Conditions associated with an increased risk of bleeding:&#xD;
&#xD;
               -  Major surgery in the previous month&#xD;
&#xD;
               -  Planned surgery or intervention in the next 3 months.&#xD;
&#xD;
               -  History of intracranial, intraocular, spinal, retroperitoneal or atraumatic&#xD;
                  intra-articular bleeding&#xD;
&#xD;
               -  Gastrointestinal hemorrhage within the past year unless the cause has been&#xD;
                  permanently eliminated (e.g. by surgery)&#xD;
&#xD;
               -  Symptomatic or endoscopically documented gastroduodenal ulcer disease in the&#xD;
                  previous 30 days&#xD;
&#xD;
               -  Hemorrhagic disorder or bleeding diathesis&#xD;
&#xD;
               -  Need for anticoagulant treatment for disorders other than AF&#xD;
&#xD;
               -  Required use of non-aspirin antiplatelet agents (i.e., Plavix) at time of&#xD;
                  enrollment&#xD;
&#xD;
               -  Uncontrolled hypertension (SBP &gt;180 mmHg and/or DBP &gt;100 mmHg)&#xD;
&#xD;
         10. Recent malignancy or radiation therapy (≤6 months)&#xD;
&#xD;
         11. Anemia (hemoglobin &lt;10g/dL) or thrombocytopenia (platelet count &lt;100K/UL)&#xD;
&#xD;
         12. Patients who have received an investigational drug in the past 30 days or are&#xD;
             participating in a drug study.&#xD;
&#xD;
         13. Intolerance or hypersensitivity to low dose aspirin therapy&#xD;
&#xD;
         14. Life expectancy less than the expected duration of the trial due to concomitant&#xD;
             disease.&#xD;
&#xD;
         15. 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).&#xD;
&#xD;
         16. Inability to comply with daily data transmission requirements.&#xD;
&#xD;
         17. Known history of isolated atrial flutter/atrial tachycardia without atrial&#xD;
             fibrillation.&#xD;
&#xD;
         18. More than 10 false positive atrial fibrillation events lasting &gt; 30 minutes per month&#xD;
             for two months prior to enrollment on a previously implantable cardiac monitor.&#xD;
&#xD;
         19. Severe renal impairment (CrCl &lt; 15 ml/min)&#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>Alexandru Chicos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Western Ontario</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>January 25, 2016</results_first_submitted>
  <results_first_submitted_qc>January 25, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 22, 2016</results_first_posted>
  <last_update_submitted>February 23, 2016</last_update_submitted>
  <last_update_submitted_qc>February 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Alexandru B Chicos</investigator_full_name>
    <investigator_title>Director, Cardiac Electrophysiology Laboratory Bluhm Cardiovascular Institute, Northwestern Memorial Hospital</investigator_title>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>reveal xt</keyword>
  <keyword>oral anticoagulation</keyword>
  <keyword>dabigatran</keyword>
  <keyword>rivaroxaban</keyword>
  <keyword>apixaban</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rivaroxaban</mesh_term>
    <mesh_term>Apixaban</mesh_term>
    <mesh_term>Dabigatran</mesh_term>
    <mesh_term>Anticoagulants</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Non-Coumadin Oral Anticoagulant</title>
          <description>Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.&#xD;
Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53">1 pt developed permanent AF; 1 pt needed dual antiplatelet therapy; 3 possible TIA; 1 withdraw</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Developed AF and need for antiplatelets</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Non-Coumadin Oral Anticoagulant</title>
          <description>Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.&#xD;
Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="59"/>
          </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="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.8" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Days on Anticoagulation</title>
        <description>Assess subject anticoagulant utilization and number of days on anticoagulation</description>
        <time_frame>up to 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-Coumadin Oral Anticoagulant</title>
            <description>Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.&#xD;
Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days on Anticoagulation</title>
          <description>Assess subject anticoagulant utilization and number of days on anticoagulation</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.9" spread="51.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bleeding Incidence</title>
        <description>To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation.</description>
        <time_frame>up to 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-Coumadin Oral Anticoagulant</title>
            <description>Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.&#xD;
Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.</description>
          </group>
        </group_list>
        <measure>
          <title>Bleeding Incidence</title>
          <description>To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stroke Rate</title>
        <description>To assess the stroke rate with implantable monitor-guided intermittent anticoagulation.</description>
        <time_frame>12 months</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Overall Survival</title>
        <description>To assess the overall survival rate with implantable monitor-guided intermittent anticoagulation.</description>
        <time_frame>12 months</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Major Bleeding-free Survival Rate</title>
        <description>To assess the major bleeding-free survival rate with implantable monitor-guided intermittent anticoagulation.</description>
        <time_frame>12 months</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stroke-free Survival Rate</title>
        <description>To assess the stroke-free survival rate with implantable monitor-guided intermittent anticoagulation.</description>
        <time_frame>12 months</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Non-Coumadin Oral Anticoagulant</title>
          <description>Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.&#xD;
Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>TIA</sub_title>
                <description>There were 3 possible TIA events. Adjudication of the three potential TIA events by an independent review committee rated two as &quot;possible TIA&quot; and one as &quot;definite TIA&quot;.</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="3" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Dual antiplatelet therapy</sub_title>
                <description>One participant required dual antiplatelet therapy.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Development of Permanent Atrial Fibrillation</sub_title>
                <description>One participant developed permanent AF.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Minor bleeding</sub_title>
                <description>There were two major bleeds following trauma, both occurring on aspirin therapy. Three minor bleeds occurred, two of which occurred on aspirin and one gastrointestinal bleed on NOAC.</description>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Major Bleeding</sub_title>
                <description>There were two major bleeds following trauma, both occurring on aspirin therapy. Three minor bleeds occurred, two of which occurred on aspirin and one gastrointestinal bleed on NOAC</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Adin-Cristian Andrei, Ph.D.</name_or_title>
      <organization>Northwestern University</organization>
      <phone>312-694-0509</phone>
      <email>Adin-Cristian.Andrei@nm.org</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/NCT01706146
org study id: STU00064217
secondary id: 1R34HL113404-01
secondary id: 7R34HL113404-03
nct id: NCT01706146
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Atrial fibrillation (AF) is the most common sustained abnormal rhythm of the heart, affects
      an estimated 2.5 to 5 million individuals in the US, and can lead to stroke, heart failure,
      and premature death. For those with AF and other stroke risk factors, chronic anticoagulation
      is recommended to prevent intracardiac thrombus formation and stroke even if the AF is
      infrequent or short-lived. This standard of care is based partly on our inability to rapidly
      recognize and respond to AF recurrences which can often be brief and asymptomatic, but
      exposes the patient to the risk of anticoagulant-induced hemorrhage even during prolonged
      periods of sinus rhythm where the risk of stroke is presumably low.

      Recent advances in device technology and drug therapy, however, have the potential to change
      the way the investigators manage AF. The use of a small leadless subcutaneous implantable
      cardiac monitor with remote data transmission capabilities (Reveal XT, Medtronic Inc.)
      provides the ability to remotely and continuously evaluate a patient for AF recurrences, even
      episodes that are brief and asymptomatic. In addition, release of unique oral thrombin
      inhibitor approved for use in non-valvular AF(Dabigatran [Pradaxa], Rivaroxaban [Xarelto])
      allows for rapid onset anticoagulation within minutes to hours of a single oral dose.
      Together, these advances allow for continuous AF monitoring with targeted anticoagulation
      only around the time of an AF episode, thereby reducing the risk of drug-induced hemorrhage
      while still protecting against stroke.

      The aim of this pilot study is to assess the feasibility of intermittent anticoagulation with
      a rapid-onset oral thrombin inhibitor guided by a continuous AF-sensing implantable cardiac
      monitor (Reveal XT) with remote data transmission capabilities.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Days on Anticoagulation
time frame: up to 12 months
description: Assess subject anticoagulant utilization and number of days on anticoagulation
measure: Bleeding Incidence
time frame: up to 12 months
description: To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation.
measure: Stroke Rate
time frame: 12 months
description: To assess the stroke rate with implantable monitor-guided intermittent anticoagulation.
measure: Overall Survival
time frame: 12 months
description: To assess the overall survival rate with implantable monitor-guided intermittent anticoagulation.
measure: Major Bleeding-free Survival Rate
time frame: 12 months
description: To assess the major bleeding-free survival rate with implantable monitor-guided intermittent anticoagulation.
measure: Stroke-free Survival Rate
time frame: 12 months
description: To assess the stroke-free survival rate with implantable monitor-guided intermittent anticoagulation.
arm group label: Non-Coumadin Oral Anticoagulant
arm group type: Other
description: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
intervention type: Drug
intervention name: Non-coumadin Oral Anticoagulant
description: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
arm group label: Non-Coumadin Oral Anticoagulant
other name: Including but not limited to:
other name: Dabigatran (Pradaxa)
other name: Rivaroxaban (Xarelto)
other name: Apixaban (Eliquis)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandru Chicos, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Alexandru B Chicos
investigator title: Director, Cardiac Electrophysiology Laboratory Bluhm Cardiovascular Institute, Northwestern Memorial Hospital
mesh term: Atrial Fibrillation
mesh term: Rivaroxaban
mesh term: Apixaban
mesh term: Dabigatran
mesh term: Anticoagulants
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 