<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/NCT03802110</url>
  </required_header>
  <id_info>
    <org_study_id>C2081</org_study_id>
    <nct_id>NCT03802110</nct_id>
  </id_info>
  <brief_title>Acute Feasibility Investigation of a New S-ICD Electrode</brief_title>
  <acronym>ASE</acronym>
  <official_title>Acute Feasibility Investigation of a New S-ICD Electrode Arrangement for Reduction of Defibrillation Energies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an early-stage feasibility study. This study seeks to characterize the performance of&#xD;
      the new electrode shock configuration with the S-ICD&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">April 1, 2022</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure defibrillation threshold defibrillation threshold (DFT) of the new shock electrode configuration in Joules</measure>
    <time_frame>Acute- During the implant procedure</time_frame>
    <description>The primary objective of this acute feasibility study is to measure the defibrillation threshold (DFT) of the new shock electrode configuration with an S-ICD system.The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Conversion succes of the new electrode configuration</measure>
    <time_frame>Acute- During the implant procedure</time_frame>
    <description>The secondary objective is to assess the conversion success of the new electrode configuration to convert VF. The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Ventricular Fibrillation</condition>
  <arm_group>
    <arm_group_label>Single Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Defibrillation threshold (DFT) testing Arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.</intervention_name>
    <description>The S-ICD System is a Subcutaneous (under the skin) Implantable Cardioverter Defibrillator for people who are at risk of Sudden Cardiac Arrest. A new electrode configuration will be tested for Defibrillation testing ( DFT). The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol</description>
    <arm_group_label>Single Arm</arm_group_label>
    <other_name>The S-ICD System is a Subcutaneous (under the skin) Implantable Cardioverter Defibrillator for people who are at risk of Sudden Cardiac Arrest</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Subject is scheduled to receive a de novo S-ICD system implant per labeled indication.&#xD;
&#xD;
          2. Passing S-ICD screening ECG performed per applicable user's manual.&#xD;
&#xD;
          3. Subject is willing and capable of providing informed consent specific to local and&#xD;
             national laws.&#xD;
&#xD;
          4. Subject is age 18 or above, or of legal age to give informed consentspecific to local&#xD;
             and national law.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Subject has an unusual chest anatomy (eg. pectus excavatum and pectus carinatum) that&#xD;
             might impede the ability to temporarily insert a second S-ICD electrode.&#xD;
&#xD;
          2. Subject has a left ventricular ejection fraction ≤ 20% within 3 months prior to&#xD;
             enrollment.&#xD;
&#xD;
          3. Subject has NYHA Class IV or unstable Class III heart failure.&#xD;
&#xD;
          4. Subject that, in the opinion of the investigator, cannot tolerate the DFT testing&#xD;
             required by this protocol.&#xD;
&#xD;
          5. Subject is morbidly obese, defined as BMI ≥ 35.&#xD;
&#xD;
          6. Subject has an active infection or has been treated for infection within the past 30&#xD;
             days.&#xD;
&#xD;
          7. Subject that, in the opinion of the investigator, has an increased risk of infection.&#xD;
&#xD;
          8. Subject is currently requiring/receiving dialysis.&#xD;
&#xD;
          9. Subject has insulin-dependent diabetes.&#xD;
&#xD;
         10. Subject had/has any prior or planned other surgical procedure within ±30 days of&#xD;
             enrollment.&#xD;
&#xD;
         11. Subject that, in the opinion of the investigator, has an increased risk for&#xD;
             thromboembolic event.&#xD;
&#xD;
         12. Subject that, in the opinion of the investigator, has an increased risk of excessive&#xD;
             bleeding.&#xD;
&#xD;
         13. Subject is currently on an active heart transplant list.&#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>Reinoud Knops</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Academisch Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC - University Medical Center Rotterdam</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isala Klinieken</name>
      <address>
        <city>Zwolle</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</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>Ventricular Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 7, 2022</submitted>
  </pending_results>
  <!-- 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/NCT03802110
org study id: C2081
nct id: NCT03802110
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This is an early-stage feasibility study. This study seeks to characterize the performance of
      the new electrode shock configuration with the S-ICD
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Measure defibrillation threshold defibrillation threshold (DFT) of the new shock electrode configuration in Joules
time frame: Acute- During the implant procedure
description: The primary objective of this acute feasibility study is to measure the defibrillation threshold (DFT) of the new shock electrode configuration with an S-ICD system.The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol
measure: Conversion succes of the new electrode configuration
time frame: Acute- During the implant procedure
description: The secondary objective is to assess the conversion success of the new electrode configuration to convert VF. The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol
arm group label: Single Arm
arm group type: Experimental
description: Defibrillation threshold (DFT) testing Arm
intervention type: Device
intervention name: commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.
description: The S-ICD System is a Subcutaneous (under the skin) Implantable Cardioverter Defibrillator for people who are at risk of Sudden Cardiac Arrest. A new electrode configuration will be tested for Defibrillation testing ( DFT). The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol
arm group label: Single Arm
other name: The S-ICD System is a Subcutaneous (under the skin) Implantable Cardioverter Defibrillator for people who are at risk of Sudden Cardiac Arrest
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Reinoud Knops
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
facility: 
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Ventricular Fibrillation
sharing ipd: No
submitted: December 7, 2022