<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/NCT03001765</url>
  </required_header>
  <id_info>
    <org_study_id>IMPACT</org_study_id>
    <nct_id>NCT03001765</nct_id>
  </id_info>
  <brief_title>Impact of an Intensive Monitoring Strategy in Symptomatic Patients With Suspected Arrhythmia</brief_title>
  <acronym>IMPACT</acronym>
  <official_title>Impact of an Intensive Monitoring Strategy in Symptomatic Patients With Suspected Arrhythmia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St Elizabeth Healthcare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St Elizabeth Healthcare</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis:&#xD;
&#xD;
      Patients that were previously discharged from the emergency department with a subsequent&#xD;
      non-diagnostic 30 day external patch monitor for suspected arrhythmia will benefit from early&#xD;
      Reveal LINQ™ Insertable Cardiac Monitoring System placement.&#xD;
&#xD;
      Primary Study Objectives:&#xD;
&#xD;
      To evaluate the outcome of an intensive monitoring strategy (patients with a negative 30 day&#xD;
      SEEQ™ Mobile Cardiac Telemetry (MCT) System result are purposed over for a Reveal LINQ™&#xD;
      Insertable Cardiac Monitoring System) in patients with suspected but no previously documented&#xD;
      arrhythmias that result in a clinically actionable event.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients will be enrolled after presentation to the Emergency Department of St.&#xD;
      Elizabeth Healthcare with symptoms suggestive of cardiac arrhythmia and prior to leaving the&#xD;
      emergency department. Patients will be exited from the study and considered complete at the&#xD;
      identification of a cardiac arrhythmia as defined in the protocol (endpoint), or 12 months&#xD;
      from enrollment date, whichever occurs first.&#xD;
&#xD;
      Protocol defined endpoints&#xD;
&#xD;
        1. Planned insertion of a permanent pacemaker, implantable cardiac defibrillator or chronic&#xD;
           resynchronization device.&#xD;
&#xD;
        2. Planned cardiac ablation procedure.&#xD;
&#xD;
        3. Initiation of medical therapy for the purpose of treating dysrhythmia.&#xD;
&#xD;
        4. Diagnosis of arrhythmia not requiring medical or invasive arrhythmia management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects in which a cardiac arrhythmia is detected from the study intervention of an intensive monitoring strategy.</measure>
    <time_frame>12 months or less</time_frame>
    <description>The number of subjects in which any cardiac arrhythmia that results in a clinically actionable event will be recorded. Descriptive statistics will be used to describe baseline study subject characteristics and the clinically actionable findings.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The total number of all significant arrhythmias detected in the study population.</measure>
    <time_frame>12 months or less</time_frame>
    <description>To determine the total number of all significant arrhythmias detected in the study population with the SEEQ™ Mobile Cardiac Telemetry (MCT) System and/or the implantable Reveal LINQ™ Insertable Cardiac Monitoring System. Subjects completing each phase of the intervention will be expressed as a percentage, as well as the percent of subjects with negative findings at the end of study participation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The average time, in days, to diagnosis of significant arrhythmia using the intervention of intensive monitoring.</measure>
    <time_frame>12 months or less</time_frame>
    <description>Compute the average time, in days, to diagnosis of significant arrhythmia using the intensive strategy of monitoring subjects with the SEEQ™ Mobile Cardiac Telemetry (MCT) System and the Reveal LINQ™ Insertable cardiac monitor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identify and categorize arrhythmia subtypes using the intensive monitoring strategy.</measure>
    <time_frame>12 months or less</time_frame>
    <description>Of those subjects with clinical findings, identify the action required, and categorize outcome as desirable, undesirable, or inconclusive.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate if the intensive monitoring strategy causes a reduction in the number and overall expense of ancillary diagnostic testing used to aid in the detection of suspected cardiac arrhythmias.</measure>
    <time_frame>12 months or less</time_frame>
    <description>In subjects with recurrent symptom, compare the intensive strategy to the number of prior tests that have been performed. In subject who have previously presented with symptoms and undergone prior diagnostic evaluation, estimate the total expense of all prior evaluation and diagnostic testing performed.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Suspected Arrhythmia</condition>
  <arm_group>
    <arm_group_label>Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intensive monitoring strategy of discharging from the Emergency Department with an external 30 day cardiac monitoring system. A negative 30 day external monitor report will be followed by an implantable cardiac monitor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System&quot;.</intervention_name>
    <description>Intensive monitoring strategy of discharge from Emergency Department with 30 day SEEQ external monitor, followed by implantable cardiac Reveal LINQ monitor if negative 30 day result.</description>
    <arm_group_label>Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years of age&#xD;
&#xD;
          -  Patient present to the ED with symptoms suggestive of cardiac arrhythmia&#xD;
&#xD;
          -  English is the patient's primary language&#xD;
&#xD;
          -  Willing and able to provide consent for participation in the study&#xD;
&#xD;
          -  Patient is willing and able to comply with the protocol including the required&#xD;
             follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  Age &lt; 18 years of age&#xD;
&#xD;
          -  Unable to provide consent&#xD;
&#xD;
          -  Current implanted loop recorder, or loop recorder explanted within the past 12 months.&#xD;
&#xD;
          -  Current implant of cardiac implantable electronic device, such as permanent pacemaker&#xD;
             (PPM), implantable cardioverter defibrillator (ICD), or cardiac resynchronization&#xD;
             therapy (CRT) device.&#xD;
&#xD;
          -  Life expectancy &lt; 12 months&#xD;
&#xD;
          -  History of prior cardiac ablation or electrophysiology study for suspected arrhythmia&#xD;
&#xD;
          -  Investigator decision related to serious comorbidities or identification of reversible&#xD;
             cause&#xD;
&#xD;
          -  Unable to comply with follow-up procedures&#xD;
&#xD;
          -  Previous documented diagnosis of cardiac arrhythmia by holter monitor, event monitor,&#xD;
             ECG.&#xD;
&#xD;
          -  Currently taking antiarrhythmic medication for a previously documented cardiac&#xD;
             arrhythmia&#xD;
&#xD;
          -  History of or suspected diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS)&#xD;
&#xD;
          -  Patient has unusual thoracic anatomy that precludes proper SEEQ patch placement&#xD;
&#xD;
          -  Patient is enrolled in another study that could confound the results of this study&#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>Thomas P Carrigan, MD, FHRS</last_name>
    <role>Principal Investigator</role>
    <affiliation>St Elizabeth Healthcare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Elizabeth Healthcare</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>October 7, 2019</last_update_submitted>
  <last_update_submitted_qc>October 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be shared.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03001765
org study id: IMPACT
nct id: NCT03001765
lead sponsor: 
has dmc: Yes
Hypothesis:

      Patients that were previously discharged from the emergency department with a subsequent
      non-diagnostic 30 day external patch monitor for suspected arrhythmia will benefit from early
      Reveal LINQ™ Insertable Cardiac Monitoring System placement.

      Primary Study Objectives:

      To evaluate the outcome of an intensive monitoring strategy (patients with a negative 30 day
      SEEQ™ Mobile Cardiac Telemetry (MCT) System result are purposed over for a Reveal LINQ™
      Insertable Cardiac Monitoring System) in patients with suspected but no previously documented
      arrhythmias that result in a clinically actionable event.
Eligible patients will be enrolled after presentation to the Emergency Department of St.
      Elizabeth Healthcare with symptoms suggestive of cardiac arrhythmia and prior to leaving the
      emergency department. Patients will be exited from the study and considered complete at the
      identification of a cardiac arrhythmia as defined in the protocol (endpoint), or 12 months
      from enrollment date, whichever occurs first.

      Protocol defined endpoints

        1. Planned insertion of a permanent pacemaker, implantable cardiac defibrillator or chronic
           resynchronization device.

        2. Planned cardiac ablation procedure.

        3. Initiation of medical therapy for the purpose of treating dysrhythmia.

        4. Diagnosis of arrhythmia not requiring medical or invasive arrhythmia management.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of subjects in which a cardiac arrhythmia is detected from the study intervention of an intensive monitoring strategy.
time frame: 12 months or less
description: The number of subjects in which any cardiac arrhythmia that results in a clinically actionable event will be recorded. Descriptive statistics will be used to describe baseline study subject characteristics and the clinically actionable findings.
measure: The total number of all significant arrhythmias detected in the study population.
time frame: 12 months or less
description: To determine the total number of all significant arrhythmias detected in the study population with the SEEQ™ Mobile Cardiac Telemetry (MCT) System and/or the implantable Reveal LINQ™ Insertable Cardiac Monitoring System. Subjects completing each phase of the intervention will be expressed as a percentage, as well as the percent of subjects with negative findings at the end of study participation.
measure: The average time, in days, to diagnosis of significant arrhythmia using the intervention of intensive monitoring.
time frame: 12 months or less
description: Compute the average time, in days, to diagnosis of significant arrhythmia using the intensive strategy of monitoring subjects with the SEEQ™ Mobile Cardiac Telemetry (MCT) System and the Reveal LINQ™ Insertable cardiac monitor.
measure: Identify and categorize arrhythmia subtypes using the intensive monitoring strategy.
time frame: 12 months or less
description: Of those subjects with clinical findings, identify the action required, and categorize outcome as desirable, undesirable, or inconclusive.
measure: Evaluate if the intensive monitoring strategy causes a reduction in the number and overall expense of ancillary diagnostic testing used to aid in the detection of suspected cardiac arrhythmias.
time frame: 12 months or less
description: In subjects with recurrent symptom, compare the intensive strategy to the number of prior tests that have been performed. In subject who have previously presented with symptoms and undergone prior diagnostic evaluation, estimate the total expense of all prior evaluation and diagnostic testing performed.
arm group label: Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac
arm group type: Other
description: Intensive monitoring strategy of discharging from the Emergency Department with an external 30 day cardiac monitoring system. A negative 30 day external monitor report will be followed by an implantable cardiac monitor.
intervention type: Other
intervention name: Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System".
description: Intensive monitoring strategy of discharge from Emergency Department with 30 day SEEQ external monitor, followed by implantable cardiac Reveal LINQ monitor if negative 30 day result.
arm group label: Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas P Carrigan, MD, FHRS
role: Principal Investigator
affiliation: St Elizabeth Healthcare
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac
sharing ipd: No
ipd description: Individual participant data will not be shared.