<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/NCT04438395</url>
  </required_header>
  <id_info>
    <org_study_id>CLN-00016</org_study_id>
    <nct_id>NCT04438395</nct_id>
  </id_info>
  <brief_title>Dielectric Tissue Imaging in Cavotricuspid Isthmus Ablation</brief_title>
  <acronym>ERUCA</acronym>
  <official_title>Dielectric Tissue Imaging in Cavotricuspid Isthmus Ablation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EPD Solutions, A Philips Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EPD Solutions, A Philips Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, single center, non-randomized, open-label, single arm study in which&#xD;
      we will gather data and physician input for the assessment and further development of the&#xD;
      KODEX - EPD functions for assessing tissue pressure, tissue thickness, lesion transmurality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single center, non-randomized, open-label, single arm study in which&#xD;
      we will gather data and physician input for the assessment and further development of the&#xD;
      KODEX - EPD functions for assessing tissue pressure, tissue thickness, lesion transmurality.&#xD;
      The study will include up to 30 subjects. We will enroll patients with atrial flutter and&#xD;
      patients with atrial fibrillation who are scheduled to undergo RF ablation of the&#xD;
      cavotricuspid isthmus (CTI). Both male and female subjects who meet all eligibility criteria&#xD;
      and give written informed consent will be enrolled in the study. We will be assessing the&#xD;
      feasibility of the KODEX-EPD tissue pressure (TP), tissue thickness and lesion transmurality&#xD;
      applications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The feasibility of KODEX-EPD tissue pressure (TP) application</measure>
    <time_frame>During procedure</time_frame>
    <description>• will be evaluated based on comparison with qualitative assessment of catheter contact by the physician during the procedure. We will ask the physician to estimate the level of pressure applied by categorizing the pressure as: no touch, touch (light), touch (firm), or high touch.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The feasibility of KODEX-EPD tissue thickness application</measure>
    <time_frame>During procedure</time_frame>
    <description>thickness values will be evaluated by checking whether they are in the range of what can be expected based on feedback from the physician upon review after the treatment (measured in mm)&#xD;
reproducibility of thickness assessment with KODEX-EPD will be calculated from repeat assessments of the same line (measured in mm)&#xD;
relative thickness values will be compared against relative thickness values measured with ICE (measured in mm)&#xD;
relative thickness values will be compared against relative thickness values derived from pre-procedural CT (measured in mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The feasibility of KODEX-EPD lesion transmurality application</measure>
    <time_frame>During procedure</time_frame>
    <description>• will be evaluated by checking whether assessments are reasonable from what can be expected based on feedback from the physician upon review after the treatment. The physician's response will be recorded as yes or no for transmurality.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Atrial Fibrillation and Flutter</condition>
  <arm_group>
    <arm_group_label>Enrolled AFL and AF Patients</arm_group_label>
    <description>All subjects that are enrolled are group one, as there is only one group of subjects in this study</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cardiac ablation via catheter</intervention_name>
    <description>Cardiac ablation with a catheter to treat atrial flutter and/or atrial fibrillation</description>
    <arm_group_label>Enrolled AFL and AF Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Atrial Flutter and patients with Atrial Fibrillation scheduled to undergo RF&#xD;
        ablation of the cavotricuspid isthmus (CTI). Both male and female subjects who meet all&#xD;
        eligibility criteria and give written informed consent will be enrolled in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject must be aged &gt;18 years.&#xD;
&#xD;
          2. Subject must have signed a written Informed Consent form to participate in the study,&#xD;
             prior to any study related procedures.&#xD;
&#xD;
          3. Subject must be willing to comply with the protocol requirements.&#xD;
&#xD;
          4. A female subject is eligible if not of child bearing potential or has a negative&#xD;
             pregnancy test within the previous 7 days.&#xD;
&#xD;
          5. Subject is deemed amenable to therapeutic ablation for atrial flutter or atrial&#xD;
             fibrillation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any planned surgical or endovascular intervention within 30 days before or after the&#xD;
             index procedure.&#xD;
&#xD;
          2. Subject is enrolled in another drug or device study protocol that has not reached its&#xD;
             primary endpoint.&#xD;
&#xD;
          3. Patient had experienced previous stroke (TIA or CVA).&#xD;
&#xD;
          4. Thrombi detected in the heart.&#xD;
&#xD;
          5. Known marked valvular insufficiency (moderate-severe and severe)&#xD;
&#xD;
          6. Life expectancy less than 12 months.&#xD;
&#xD;
          7. Known severe renal insufficiency (stages G4 and G5, characterized by severe reduction&#xD;
             in GFR [15-29 ml/min/1.73 m2] and GFR [&lt;15 ml/min/1.73 m2], respectively).&#xD;
&#xD;
          8. Subjects that according to the clinical judgment of the caring physician do not fit&#xD;
             for the study.&#xD;
&#xD;
          9. Previous right atrial ablation procedure or cardiac ablation procedure performed&#xD;
             within 90 days prior to 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>Larry Chinitz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anneleen Viville</last_name>
    <phone>+32479983495</phone>
    <email>Anneleen.Viville@philips.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>April Jacob</last_name>
      <phone>212-263-7704</phone>
      <email>April.Jacob@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Chinitz</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 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>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>May 9, 2023</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/NCT04438395
org study id: CLN-00016
nct id: NCT04438395
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a prospective, single center, non-randomized, open-label, single arm study in which
      we will gather data and physician input for the assessment and further development of the
      KODEX - EPD functions for assessing tissue pressure, tissue thickness, lesion transmurality.
This is a prospective, single center, non-randomized, open-label, single arm study in which
      we will gather data and physician input for the assessment and further development of the
      KODEX - EPD functions for assessing tissue pressure, tissue thickness, lesion transmurality.
      The study will include up to 30 subjects. We will enroll patients with atrial flutter and
      patients with atrial fibrillation who are scheduled to undergo RF ablation of the
      cavotricuspid isthmus (CTI). Both male and female subjects who meet all eligibility criteria
      and give written informed consent will be enrolled in the study. We will be assessing the
      feasibility of the KODEX-EPD tissue pressure (TP), tissue thickness and lesion transmurality
      applications.
observational model: Case-Only
time perspective: Other
measure: The feasibility of KODEX-EPD tissue pressure (TP) application
time frame: During procedure
description: • will be evaluated based on comparison with qualitative assessment of catheter contact by the physician during the procedure. We will ask the physician to estimate the level of pressure applied by categorizing the pressure as: no touch, touch (light), touch (firm), or high touch.
measure: The feasibility of KODEX-EPD tissue thickness application
time frame: During procedure
description: thickness values will be evaluated by checking whether they are in the range of what can be expected based on feedback from the physician upon review after the treatment (measured in mm)
reproducibility of thickness assessment with KODEX-EPD will be calculated from repeat assessments of the same line (measured in mm)
relative thickness values will be compared against relative thickness values measured with ICE (measured in mm)
relative thickness values will be compared against relative thickness values derived from pre-procedural CT (measured in mm)
measure: The feasibility of KODEX-EPD lesion transmurality application
time frame: During procedure
description: • will be evaluated by checking whether assessments are reasonable from what can be expected based on feedback from the physician upon review after the treatment. The physician's response will be recorded as yes or no for transmurality.
arm group label: Enrolled AFL and AF Patients
description: All subjects that are enrolled are group one, as there is only one group of subjects in this study
intervention type: Device
intervention name: Cardiac ablation via catheter
description: Cardiac ablation with a catheter to treat atrial flutter and/or atrial fibrillation
arm group label: Enrolled AFL and AF Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Larry Chinitz, MD
role: Principal Investigator
affiliation: NYU Langone Health
last name: Anneleen Viville
phone: +32479983495
email: Anneleen.Viville@philips.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
submitted: May 9, 2023