<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/NCT02186704</url>
  </required_header>
  <id_info>
    <org_study_id>1401014661</org_study_id>
    <nct_id>NCT02186704</nct_id>
  </id_info>
  <brief_title>Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial)</brief_title>
  <acronym>SENSE</acronym>
  <official_title>Sensing Atrial High Rate Episodes With DX System in Implantable Cardioverter Defibrillators Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biotronik, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of the &quot;Sensing Atrial High Rate Episodes with DX System in Implantable&#xD;
      Cardioverter Defibrillators Trial&quot; (SENSE Trial) is to assess the efficacy of a implantable&#xD;
      cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles in detecting&#xD;
      atrial high rate episodes.&#xD;
&#xD;
      The study hypothesis is that an ICD system with a lead with dedicated atrial sensing dipoles&#xD;
      will have a diagnostic yield comparable to that of a standard dual chamber ICD system and&#xD;
      superior to that of a standard single chamber ICD system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SENSE Trial is designed to study the efficacy of the DX System in detection of atrial&#xD;
      high rate episodes (AHREs) in subjects with no prior history of atrial fibrillation. The DX&#xD;
      System, or &quot;DX,&quot; consists of a Biotronik DX ICD, and the Biotronik Linox Smart S DX lead&#xD;
      which is an FDA approved ICD system that incorporates use of an implantable&#xD;
      cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles.&#xD;
&#xD;
      The SENSE Trial will be conducted at 8-12 U.S. sites. The lead coordinating site will be at&#xD;
      Weill Cornell Medical College. Subjects will be followed for 1 year to assess for the primary&#xD;
      endpoints of the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Atrial High Rate Episode</measure>
    <time_frame>1 year</time_frame>
    <description>Atrial high rate episode &gt; 30 seconds in duration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Atrial Sensing (DX System)</measure>
    <time_frame>1 year</time_frame>
    <description>P wave amplitudes measured by DX lead system</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Atrial High Rate Episode &gt; 6 Minutes (DX System)</measure>
    <time_frame>1 year</time_frame>
    <description>Detection of AHRE &gt; 6 minutes duration by DX lead system</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">450</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>ICD with DX system</arm_group_label>
    <description>Implantable cardioverter-defibrillator recipients with DX system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dual chamber ICD</arm_group_label>
    <description>Dual chamber implantable-cardioverter-defibrillator recipients (retrospective cohort from IMPACT study)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single chamber ICD</arm_group_label>
    <description>Single chamber implantable cardioverter-defibrillator recipients (retrospective cohort from Cornell registry)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ICD with DX system</intervention_name>
    <description>Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole.</description>
    <arm_group_label>ICD with DX system</arm_group_label>
    <other_name>Biotronik Ilesto 7 VR-T ICD</other_name>
    <other_name>Biotronik Lumax Smart S DX ICD lead</other_name>
    <other_name>Future FDA-approved Biotronik DX-capable ICD and leads</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with standard indications for implantable cardioverter-defibrillator implantation&#xD;
        and no prior history of atrial fibrillation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fulfills standard indications for ICD implantation&#xD;
&#xD;
          -  Subject or legally authorized representative can provide written authorization per&#xD;
             institutional requirements&#xD;
&#xD;
          -  Subject is intended to be implanted with a complete Biotronik DX system (consisting of&#xD;
             a Biotronik Ilesto 7 VR-T DX ICD or any future FDA approved Lumax VR-T DX ICD, and the&#xD;
             Biotronik Linox Smart S DX lead), or has been implanted with a complete Biotronik DX&#xD;
             system no more than 30 days prior to the date of consent&#xD;
&#xD;
          -  Able to comply with Home Monitoring&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has prior diagnosis of atrial fibrillation or atrial flutter&#xD;
&#xD;
          -  Subject has need for atrial pacing&#xD;
&#xD;
          -  Subject unwilling or unable to give informed consent or participate in follow-up&#xD;
&#xD;
          -  Subject is unable to comply with Home Monitoring&#xD;
&#xD;
          -  Subject is pregnant&#xD;
&#xD;
          -  Subject has less than one year estimated life expectancy&#xD;
&#xD;
          -  Subject was implanted with a cardiac device capable of detecting AHREs prior to&#xD;
             implantation of the Biotronik DX system&#xD;
&#xD;
          -  Subject was implanted with Biotronik DX system and had an AHRE detection before&#xD;
             enrollment&#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>George Thomas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westchester Medical Center</name>
      <address>
        <city>Valhalla</city>
        <state>New York</state>
        <zip>10532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State Wexner University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Promedica Heart and Vascular Institute</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Einstein Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>August 27, 2018</last_update_submitted>
  <last_update_submitted_qc>August 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Implantable Defibrillators</keyword>
  <keyword>Implanted Electrodes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02186704
org study id: 1401014661
nct id: NCT02186704
lead sponsor: 
collaborator: 
has dmc: Yes
The primary aim of the "Sensing Atrial High Rate Episodes with DX System in Implantable
      Cardioverter Defibrillators Trial" (SENSE Trial) is to assess the efficacy of a implantable
      cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles in detecting
      atrial high rate episodes.

      The study hypothesis is that an ICD system with a lead with dedicated atrial sensing dipoles
      will have a diagnostic yield comparable to that of a standard dual chamber ICD system and
      superior to that of a standard single chamber ICD system.
The SENSE Trial is designed to study the efficacy of the DX System in detection of atrial
      high rate episodes (AHREs) in subjects with no prior history of atrial fibrillation. The DX
      System, or "DX," consists of a Biotronik DX ICD, and the Biotronik Linox Smart S DX lead
      which is an FDA approved ICD system that incorporates use of an implantable
      cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles.

      The SENSE Trial will be conducted at 8-12 U.S. sites. The lead coordinating site will be at
      Weill Cornell Medical College. Subjects will be followed for 1 year to assess for the primary
      endpoints of the trial.
observational model: Case-Control
time perspective: Prospective
measure: Atrial High Rate Episode
time frame: 1 year
description: Atrial high rate episode > 30 seconds in duration
measure: Atrial Sensing (DX System)
time frame: 1 year
description: P wave amplitudes measured by DX lead system
measure: Atrial High Rate Episode > 6 Minutes (DX System)
time frame: 1 year
description: Detection of AHRE > 6 minutes duration by DX lead system
arm group label: ICD with DX system
description: Implantable cardioverter-defibrillator recipients with DX system
arm group label: Dual chamber ICD
description: Dual chamber implantable-cardioverter-defibrillator recipients (retrospective cohort from IMPACT study)
arm group label: Single chamber ICD
description: Single chamber implantable cardioverter-defibrillator recipients (retrospective cohort from Cornell registry)
intervention type: Device
intervention name: ICD with DX system
description: Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole.
arm group label: ICD with DX system
other name: Biotronik Ilesto 7 VR-T ICD
other name: Biotronik Lumax Smart S DX ICD lead
other name: Future FDA-approved Biotronik DX-capable ICD and leads
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: George Thomas, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No