<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/NCT02188147</url>
  </required_header>
  <id_info>
    <org_study_id>90D0119</org_study_id>
    <nct_id>NCT02188147</nct_id>
  </id_info>
  <brief_title>Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study</brief_title>
  <acronym>ASAP</acronym>
  <official_title>Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zoll Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zoll Medical Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to conduct an observational investigation of a novel care path&#xD;
      used to manage emergency department (ED) presenting syncope patients on an outpatient basis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES To conduct a prospective observational study assessing a unique outpatient care&#xD;
      model in which syncope patients are provided with, and trained to use, a wearable&#xD;
      defibrillator prior to discharge from the emergency department (ED). Observational data will&#xD;
      be collected to assess the logistics of equipping patients with the device and providing&#xD;
      training in the ED, and the ability of patients to receive follow-up care on an outpatient&#xD;
      basis. In addition, data will be collected to confirm that the device meets expected safety.&#xD;
      The experience gained from this stage of the study will be used to guide future studies of&#xD;
      device's functionality enhancements and definitive device safety and efficacy.&#xD;
&#xD;
      STUDY POPULATION Participants will be patients presenting to the ED following a syncope event&#xD;
      which has been defined as cardiac, or potentially cardiac, i.e. undiagnosed in nature.&#xD;
&#xD;
      INTERVENTION A wearable defibrillator optimized for short-term ambulatory use with adhesive&#xD;
      electrodes will be prescribed for up to 14 days of use following emergency department&#xD;
      discharge or until the physician responsible for the subject's care defines an alternative&#xD;
      treatment plan.&#xD;
&#xD;
      STUDY DESIGN This is a single-arm feasibility study.&#xD;
&#xD;
      STUDY SIZE The study will enroll a minimum of 50 and a maximum of 80 subjects. A maximum of&#xD;
      20 centers will be used for enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">April 15, 2020</completion_date>
  <primary_completion_date type="Actual">April 2020</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Device Unable to Monitor Due to ECG Noise</measure>
    <time_frame>enrollment to 30 days</time_frame>
    <description>% time the device detected noise on both leads at the same time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Device Monitoring Using Only One ECG Lead</measure>
    <time_frame>enrollment to 30 days</time_frame>
    <description>% time that the device is monitoring using only one lead due to noise detected on the other lead</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Followup Care Visits</measure>
    <time_frame>enrollment to 30 days</time_frame>
    <description>Followup care for syncope - outpatient medical care visits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ER or Hospitalization</measure>
    <time_frame>enrollment to 30 days</time_frame>
    <description>Followup care for syncope - returned to ER or admitted to hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Use</measure>
    <time_frame>enrollment to 30 days</time_frame>
    <description>Average time the SWD 1000 was used by participants</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Syncope</condition>
  <arm_group>
    <arm_group_label>SWD 1000</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Short Term Wearable Defibrillator</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Short Term Wearable Defibrillator</intervention_name>
    <description>Short-term Wearable Defibrillator (SWD 1000)</description>
    <arm_group_label>SWD 1000</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age≥18&#xD;
&#xD;
          2. Experienced a syncopal event within the past 48 hours&#xD;
&#xD;
          3. Either one of the following profiles(A or B) apply:&#xD;
&#xD;
        A. ED workup indicates that the patient may have experienced syncope that is cardiac in&#xD;
        nature (any one or more of the following apply:&#xD;
&#xD;
          -  History or diagnosis of structural heart disease&#xD;
&#xD;
          -  History of cardiovascular disease&#xD;
&#xD;
          -  Age ≥ 40&#xD;
&#xD;
          -  Palpitations experienced pre-syncope&#xD;
&#xD;
          -  Major ECG abnormalities:&#xD;
&#xD;
               -  QRS-duration greater than 140 ms&#xD;
&#xD;
               -  PR-interval greater than 200 ms&#xD;
&#xD;
               -  Non-specific repolarization abnormality&#xD;
&#xD;
          -  Syncope experienced without any warning&#xD;
&#xD;
          -  Syncope experienced while supine&#xD;
&#xD;
          -  Syncope during exercise B. ED workup does not indicate a clear cause of the syncopal&#xD;
             event&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clear diagnosis of non-cardiac syncope (e.g. orthostatic hypotensive syncope,&#xD;
             vasovagal syncope, carotid sinus syncope, situational fainting)&#xD;
&#xD;
          2. An active implantable cardioverter-defibrillator (ICD)&#xD;
&#xD;
          3. An active unipolar pacemaker&#xD;
&#xD;
          4. Significant risk or suffering a cardiovascular event such as:&#xD;
&#xD;
               -  Symptoms of New York Heart Association (NYHA) class III or IV heart failure&#xD;
&#xD;
               -  ED diagnosis of acute coronary syndrome&#xD;
&#xD;
               -  Having required resuscitation in response to the index syncopal event&#xD;
&#xD;
               -  Advanced directive prohibiting resuscitation (DNR)&#xD;
&#xD;
        6. Physical or mental conditions preventing subjects from interacting with or wearing the&#xD;
        device as determined by the investigating physician.&#xD;
&#xD;
        7. Bandages or other clinical condition preventing SWD 1000 use 8. Injuries or other&#xD;
        conditions beyond simple syncope that require hospitalization 9. Travel out of town during&#xD;
        the study participation period that prevents the field service representative from visiting&#xD;
        the subject daily 10. Unable or unwilling to provide written informed consent&#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>Steve Szymkiewicz, MD</last_name>
    <role>Study Director</role>
    <affiliation>Zoll Medical Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <results_first_submitted>January 24, 2023</results_first_submitted>
  <results_first_submitted_qc>January 24, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2023</results_first_posted>
  <last_update_submitted>January 24, 2023</last_update_submitted>
  <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Syncope</keyword>
  <keyword>Sudden Cardiac Arrest</keyword>
  <keyword>Sudden Cardiac Death</keyword>
  <keyword>Cardiac Arrest</keyword>
  <keyword>Emergency Service</keyword>
  <keyword>Emergency Department</keyword>
  <keyword>Ambulatory Electrocardiography</keyword>
  <keyword>Holter</keyword>
  <keyword>Holter Electrocardiography</keyword>
  <keyword>Holter Monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syncope</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT02188147/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SWD 1000</title>
          <description>Patients who presented to the emergency room after syncope, and their syncopal event was believed to have a cardiac or undiagnosed cause. In this group participants agreed to wear the Short Term Wearable Defibrillator 1000 (SWD 1000) after discharge for up to 14 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SWD 1000</title>
          <description>Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.4" spread="17.8"/>
                  </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="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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="39"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.5" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="185.2" spread="51.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood pressure</title>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Systolic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="127" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Heart rate</title>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Respiration rate</title>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.4" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior syncope</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Past history of myocardial infarction</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Past history of heart failure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Past history of diabetes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Past history of atrial fibrillation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Past history of renal failure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Active pacemaker</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family history of sudden death</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Device Unable to Monitor Due to ECG Noise</title>
        <description>% time the device detected noise on both leads at the same time.</description>
        <time_frame>enrollment to 30 days</time_frame>
        <population>Subjects who used the SWD1000 for at least 24 hours</population>
        <group_list>
          <group group_id="O1">
            <title>SWD 1000</title>
            <description>Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)</description>
          </group>
        </group_list>
        <measure>
          <title>Device Unable to Monitor Due to ECG Noise</title>
          <description>% time the device detected noise on both leads at the same time.</description>
          <population>Subjects who used the SWD1000 for at least 24 hours</population>
          <units>percentage of time worn</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="0.59" upper_limit="2.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Device Monitoring Using Only One ECG Lead</title>
        <description>% time that the device is monitoring using only one lead due to noise detected on the other lead</description>
        <time_frame>enrollment to 30 days</time_frame>
        <population>SWD 1000 participants who used the device at least 24 hours.</population>
        <group_list>
          <group group_id="O1">
            <title>SWD 1000</title>
            <description>Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)</description>
          </group>
        </group_list>
        <measure>
          <title>Device Monitoring Using Only One ECG Lead</title>
          <description>% time that the device is monitoring using only one lead due to noise detected on the other lead</description>
          <population>SWD 1000 participants who used the device at least 24 hours.</population>
          <units>percentage of time worn</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="2.44" upper_limit="4.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Followup Care Visits</title>
        <description>Followup care for syncope - outpatient medical care visits</description>
        <time_frame>enrollment to 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SWD 1000</title>
            <description>Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)</description>
          </group>
        </group_list>
        <measure>
          <title>Followup Care Visits</title>
          <description>Followup care for syncope - outpatient medical care visits</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>ER or Hospitalization</title>
        <description>Followup care for syncope - returned to ER or admitted to hospital</description>
        <time_frame>enrollment to 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SWD 1000</title>
            <description>Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)</description>
          </group>
        </group_list>
        <measure>
          <title>ER or Hospitalization</title>
          <description>Followup care for syncope - returned to ER or admitted to hospital</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Use</title>
        <description>Average time the SWD 1000 was used by participants</description>
        <time_frame>enrollment to 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SWD 1000</title>
            <description>Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Use</title>
          <description>Average time the SWD 1000 was used by participants</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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Noise Alarms</title>
        <description>SWD 1000 alarms given to alert user of detected noise on one or more ECG leads</description>
        <time_frame>enrollment to 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SWD 1000</title>
            <description>Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)</description>
          </group>
        </group_list>
        <measure>
          <title>Noise Alarms</title>
          <description>SWD 1000 alarms given to alert user of detected noise on one or more ECG leads</description>
          <units>count of alarms per subject</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Arrhythmia Alarms</title>
        <description>Device alarms given because an arrhythmia was detected (may or may not be real arrhythmia)</description>
        <time_frame>enrollment to 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SWD 1000</title>
            <description>Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)</description>
          </group>
        </group_list>
        <measure>
          <title>Arrhythmia Alarms</title>
          <description>Device alarms given because an arrhythmia was detected (may or may not be real arrhythmia)</description>
          <units>number of alarms per subjects</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9" spread="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SWD 1000</title>
          <description>Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="13" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Inappropriate shock</sub_title>
                <description>A defibrillation shock was delivered when the patient was not experiencing a treatable arrhythmia</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin rash or irritation</sub_title>
                <description>Skin rash or irritation (no medical intervention required)</description>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="39"/>
              </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>Vice President Medical Affairs</name_or_title>
      <organization>ZOLL</organization>
      <phone>412-968-3333 ext 4400</phone>
      <email>stevens@zoll.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/NCT02188147
org study id: 90D0119
nct id: NCT02188147
lead sponsor: 
has dmc: No
The purpose of this study is to conduct an observational investigation of a novel care path
      used to manage emergency department (ED) presenting syncope patients on an outpatient basis.
OBJECTIVES To conduct a prospective observational study assessing a unique outpatient care
      model in which syncope patients are provided with, and trained to use, a wearable
      defibrillator prior to discharge from the emergency department (ED). Observational data will
      be collected to assess the logistics of equipping patients with the device and providing
      training in the ED, and the ability of patients to receive follow-up care on an outpatient
      basis. In addition, data will be collected to confirm that the device meets expected safety.
      The experience gained from this stage of the study will be used to guide future studies of
      device's functionality enhancements and definitive device safety and efficacy.

      STUDY POPULATION Participants will be patients presenting to the ED following a syncope event
      which has been defined as cardiac, or potentially cardiac, i.e. undiagnosed in nature.

      INTERVENTION A wearable defibrillator optimized for short-term ambulatory use with adhesive
      electrodes will be prescribed for up to 14 days of use following emergency department
      discharge or until the physician responsible for the subject's care defines an alternative
      treatment plan.

      STUDY DESIGN This is a single-arm feasibility study.

      STUDY SIZE The study will enroll a minimum of 50 and a maximum of 80 subjects. A maximum of
      20 centers will be used for enrollment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Device Unable to Monitor Due to ECG Noise
time frame: enrollment to 30 days
description: % time the device detected noise on both leads at the same time.
measure: Device Monitoring Using Only One ECG Lead
time frame: enrollment to 30 days
description: % time that the device is monitoring using only one lead due to noise detected on the other lead
measure: Followup Care Visits
time frame: enrollment to 30 days
description: Followup care for syncope - outpatient medical care visits
measure: ER or Hospitalization
time frame: enrollment to 30 days
description: Followup care for syncope - returned to ER or admitted to hospital
measure: Duration of Use
time frame: enrollment to 30 days
description: Average time the SWD 1000 was used by participants
arm group label: SWD 1000
arm group type: Experimental
description: Short Term Wearable Defibrillator
intervention type: Device
intervention name: Short Term Wearable Defibrillator
description: Short-term Wearable Defibrillator (SWD 1000)
arm group label: SWD 1000
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steve Szymkiewicz, MD
role: Study Director
affiliation: Zoll Medical Corporation
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Syncope
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 