<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/NCT03239444</url>
  </required_header>
  <id_info>
    <org_study_id>EXT-001-1.5</org_study_id>
    <nct_id>NCT03239444</nct_id>
  </id_info>
  <brief_title>Foresight Intracardiac Echocardiography System (ICE)</brief_title>
  <official_title>Visualization of Human Cardiovascular Anatomy With Foresight Intracardiac Echocardiography (ICE) System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Conavi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Conavi</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy of the Foresight Intracardiac Echocardiography system&#xD;
      ,with improved image quality, in guiding trans-septal punctures during atrial fibrillation&#xD;
      ablation procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will recruit 10 patients at a single center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 24, 2017</start_date>
  <completion_date type="Actual">December 24, 2018</completion_date>
  <primary_completion_date type="Actual">December 24, 2018</primary_completion_date>
  <phase>Phase 1</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>Evaluation of the study device for guiding transseptal puncture in order to gain access to the left atrium of the heart during an ablation procedure in patients suffering with atrial fibrillation.</measure>
    <time_frame>For each patient, the individual physician satisfaction survey will be completed on the day of the procedure.</time_frame>
    <description>The ability of the study device to identify the atrial septum during transseptal puncture will be evaluated by the physician on the day of the procedure and captured in the individual case report form. This will be based on the objective finding of whether the transseptal puncture was performed (Yes or No) under study device guidance. This information will be gathered for each patient in the individual case report form and presented qualitatively and as quantitative measures (percentage success).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Collection of first human images with Conavi's Foresight System.</measure>
    <time_frame>An individual physician satisfaction survey will be completed for each case on the day of the procedure.</time_frame>
    <description>The Conavi's Foresight System will be utilized to capture images of relevant human cardiac anatomical landmarks (e.g. crista terminalis, tricuspid valve, coronary sinus) while the catheter will be manipulated inside the heart during the procedure. The physician satisfaction survey will ask the physician to specifically tabulate structures that could be identified in a binary yes/no format.&#xD;
This kind of information will be gathered for each patient in the individual physician satisfaction surveys and presented qualitatively.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Assigned Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Device: Foresight ICE System The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird console. The Foresight ICE system will be used in guiding the physician during the trans-septal puncture and provide physiological information during the course of the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intracardiac echocardiography imaging</intervention_name>
    <description>Wide visualization of the the heart anatomy and additional devices used during atrial fibrillation ablation procedures.</description>
    <arm_group_label>Assigned Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is at least 18 years old.&#xD;
&#xD;
          -  Patient is undergoing an atrial fibrillation ablation procedure.&#xD;
&#xD;
          -  Patient has a transesophageal echocardiogram (TEE) within the 48 hours prior to&#xD;
             ablation procedure to rule out left atrial thrombus.&#xD;
&#xD;
          -  Patient provides informed, written consent for participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in whom placement of an ICE catheter in the right atrium for adequate atrial&#xD;
             visualization is not technically feasible (as evaluated and determined by the&#xD;
             physician/study investigator performing the procedure).&#xD;
&#xD;
          -  Patients in whom transseptal puncture is relatively contraindicated.&#xD;
&#xD;
          -  Patients in whom left atrial clot or dense spontaneous contrast is identified on TEE,&#xD;
             which would increase thromboembolic risk.&#xD;
&#xD;
          -  Women of child bearing potential, in whom pregnancy cannot be excluded.&#xD;
&#xD;
          -  Patients unable to grant informed, written consent for participation in the 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>Atul Verma, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southlake Regional Health Center, Newmarket, Ontario, Canada, L3Y2P6</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southlake Regional Health Centre</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <zip>L3Y2P6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ICE</keyword>
  <keyword>Ablation</keyword>
  <keyword>Trans-septal</keyword>
  <keyword>Septum</keyword>
  <keyword>Echocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- 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/NCT03239444
org study id: EXT-001-1.5
nct id: NCT03239444
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will evaluate the efficacy of the Foresight Intracardiac Echocardiography system
      ,with improved image quality, in guiding trans-septal punctures during atrial fibrillation
      ablation procedures.
The study will recruit 10 patients at a single center.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Evaluation of the study device for guiding transseptal puncture in order to gain access to the left atrium of the heart during an ablation procedure in patients suffering with atrial fibrillation.
time frame: For each patient, the individual physician satisfaction survey will be completed on the day of the procedure.
description: The ability of the study device to identify the atrial septum during transseptal puncture will be evaluated by the physician on the day of the procedure and captured in the individual case report form. This will be based on the objective finding of whether the transseptal puncture was performed (Yes or No) under study device guidance. This information will be gathered for each patient in the individual case report form and presented qualitatively and as quantitative measures (percentage success).
measure: Collection of first human images with Conavi's Foresight System.
time frame: An individual physician satisfaction survey will be completed for each case on the day of the procedure.
description: The Conavi's Foresight System will be utilized to capture images of relevant human cardiac anatomical landmarks (e.g. crista terminalis, tricuspid valve, coronary sinus) while the catheter will be manipulated inside the heart during the procedure. The physician satisfaction survey will ask the physician to specifically tabulate structures that could be identified in a binary yes/no format.
This kind of information will be gathered for each patient in the individual physician satisfaction surveys and presented qualitatively.
arm group label: Assigned Intervention
arm group type: Other
description: Device: Foresight ICE System The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird console. The Foresight ICE system will be used in guiding the physician during the trans-septal puncture and provide physiological information during the course of the procedure.
intervention type: Device
intervention name: Intracardiac echocardiography imaging
description: Wide visualization of the the heart anatomy and additional devices used during atrial fibrillation ablation procedures.
arm group label: Assigned Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Atul Verma, MD
role: Principal Investigator
affiliation: Southlake Regional Health Center, Newmarket, Ontario, Canada, L3Y2P6
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Atrial Fibrillation