<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/NCT03033641</url>
  </required_header>
  <id_info>
    <org_study_id>BWI CF-172</org_study_id>
    <nct_id>NCT03033641</nct_id>
  </id_info>
  <brief_title>FIND CAN Trial: &quot;CF-172&quot;</brief_title>
  <acronym>FIND CAN</acronym>
  <official_title>Feasibility of the CARTOFINDER™ 4D LAT Algorithm to Identify Ablation Target in Subjects With Atrial Fibrillation (FIND CAN Trial: &quot;CF-172&quot;)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biosense Webster, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biosense Webster, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this feasibility study is to further explore characteristics of ablation&#xD;
      targets identified by CARTOFINDER 4D LAT Algorithm in subjects with persistent atrial&#xD;
      fibrillation and to assess the acute outcome of CARTOFINDER Guided Ablation in terms of the&#xD;
      termination of atrial fibrillation to either Normal Sinus Rhythm or Atrial Tachycardia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2016</start_date>
  <completion_date type="Actual">August 30, 2017</completion_date>
  <primary_completion_date type="Actual">May 4, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate mapping characteristics</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Explore characteristics of ablation targets identified by the CARTOFINDER 4D LAT Algorithm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate acute safety of freedom from procedure-related primary adverse events</measure>
    <time_frame>Within 7 days</time_frame>
    <description>Evaluate acute safety of freedom from procedure-related primary adverse events occurring within 7 days of ablation procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate atrial fibrillation (AF) termination</measure>
    <time_frame>Perioperative</time_frame>
    <description>Evaluate the AF termination to Normal Sinus Rhythm (NSR) or an Atrial Tachycardia (AT) after CARTOFINDER™ Guided Ablation (CFGA) of identified ablation target and after PVI</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Ablation procedure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ablation procedure</intervention_name>
    <description>All enrolled subjects who have ablation targets identified will undergo CARTOFINDER guided ablation (CFGA) followed by PVI. Subjects will be followed per the protocol schedule. Subjects who have no ablation target identified on the baseline CARTOFINDER map will undergo ablation per the institution's standard of care and be followed for 7 days for safety monitoring, then exit from the study.</description>
    <arm_group_label>Ablation procedure</arm_group_label>
    <other_name>CARTOFINDER™ Workstation, CARTO® 3 EP Navigation System, with CARTOFINDER™ 4D LAT Algorithm installed (CARTOFINDER™ Module)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects must meet the following inclusion criteria:&#xD;
&#xD;
          1. Age &gt; 18 years.&#xD;
&#xD;
          2. Patients who have signed the Patient Informed Consent Form (ICF)&#xD;
&#xD;
          3. Scheduled to undergo a clinically-indicated catheter ablation procedure for treatment&#xD;
             of persistent atrial fibrillation (defined as continuous atrial fibrillation that is&#xD;
             sustained beyond seven consecutive days).&#xD;
&#xD;
             3.1. Drug-refractory atrial fibrillation. (failed 1 or more class I or III&#xD;
             antiarrhythmic drugs) and demonstrating Persistent AF (requiring drugs or electrical&#xD;
             shock to terminate)&#xD;
&#xD;
          4. Able and willing to comply with all pre-, post-, and follow-up testing and&#xD;
             requirements (e.g. patients not confined by a court ruling)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subject who meet any of the following exclusion criteria are not eligible for enrollment.&#xD;
&#xD;
          1. Paroxysmal Atrial Fibrillation&#xD;
&#xD;
          2. Continuous AF &gt; 12 months (1 Year) (Longstanding Persistent AF) 2.1. Subjects&#xD;
             previously diagnosed as Long Standing Persistent (LSP) but have demonstrated the&#xD;
             ability to maintain Normal Sinus Rhythm for &gt;30 days after cardioversion and have not&#xD;
             been in AF greater than 1 year at the time of the procedure remain eligible for&#xD;
             inclusion.&#xD;
&#xD;
          3. Previous ablation procedure for AF (previous ablation for the treatment of Flutter is&#xD;
             acceptable)&#xD;
&#xD;
          4. Patients with a left atrial size &gt;55 mm (echocardiography, parasternal long axis&#xD;
             view).&#xD;
&#xD;
          5. Inability to restore sinus rhythm for 30 seconds or longer in the opinion of the&#xD;
             investigator.&#xD;
&#xD;
          6. Significant congenital anomaly or medical problem that in the opinion of the&#xD;
             investigator would preclude enrollment in this study.&#xD;
&#xD;
          7. Atrial arrhythmia patients with structural atrial disease such as a prior history of&#xD;
             atriotomy from prior atrial surgery, presence of an atrial septal defect, and/or&#xD;
             presence of an atrial septal closure patch.&#xD;
&#xD;
          8. History of or current blood clotting or bleeding abnormalities, contraindication to&#xD;
             systemic anticoagulation (i.e., heparin, warfarin, dabigatran, or a direct thrombin&#xD;
             inhibitor), significant pulmonary disease, unstable angina, uncontrolled heart&#xD;
             failure, acute illness or systemic infection, or any other disease or malfunction that&#xD;
             would preclude treatment in the opinion of the investigator.&#xD;
&#xD;
          9. Enrollment in a study evaluating another device or drug.&#xD;
&#xD;
         10. A complex arrhythmia secondary to electrolyte imbalance, thyroid disease, or&#xD;
             reversible or non-cardiac cause.&#xD;
&#xD;
         11. Patients with a prosthetic mitral valve or any mechanical valve&#xD;
&#xD;
         12. Any cardiac surgery within the past 60 days (2 months) (includes PCI) (bypass within&#xD;
             the past year)&#xD;
&#xD;
         13. Subjects that have ever undergone valvular cardiac surgical procedure (ie,&#xD;
             ventriculotomy, atriotomy, and valve repair or replacement and presence of a&#xD;
             prosthetic valve)&#xD;
&#xD;
         14. Prior ICD or pacemaker implanted&#xD;
&#xD;
         15. Presence of intramural thrombus, tumor or other abnormality that precludes catheter&#xD;
             introduction or manipulation.&#xD;
&#xD;
         16. Presence of a condition that precludes vascular access.&#xD;
&#xD;
         17. Subject has a contra-indication to any of the devices used in the study per the IFU&#xD;
&#xD;
         18. Women of child bearing potential who are pregnant, lactating, or planning to become&#xD;
             pregnant during the course of the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Southlake Regional Health Center</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <zip>L3Y 2P9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>February 6, 2018</last_update_submitted>
  <last_update_submitted_qc>February 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2018</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>
  <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/NCT03033641
org study id: BWI CF-172
nct id: NCT03033641
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this feasibility study is to further explore characteristics of ablation
      targets identified by CARTOFINDER 4D LAT Algorithm in subjects with persistent atrial
      fibrillation and to assess the acute outcome of CARTOFINDER Guided Ablation in terms of the
      termination of atrial fibrillation to either Normal Sinus Rhythm or Atrial Tachycardia.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate mapping characteristics
time frame: Intraoperative
description: Explore characteristics of ablation targets identified by the CARTOFINDER 4D LAT Algorithm
measure: Evaluate acute safety of freedom from procedure-related primary adverse events
time frame: Within 7 days
description: Evaluate acute safety of freedom from procedure-related primary adverse events occurring within 7 days of ablation procedure
measure: Evaluate atrial fibrillation (AF) termination
time frame: Perioperative
description: Evaluate the AF termination to Normal Sinus Rhythm (NSR) or an Atrial Tachycardia (AT) after CARTOFINDER™ Guided Ablation (CFGA) of identified ablation target and after PVI
arm group label: Ablation procedure
arm group type: Experimental
intervention type: Device
intervention name: Ablation procedure
description: All enrolled subjects who have ablation targets identified will undergo CARTOFINDER guided ablation (CFGA) followed by PVI. Subjects will be followed per the protocol schedule. Subjects who have no ablation target identified on the baseline CARTOFINDER map will undergo ablation per the institution's standard of care and be followed for 7 days for safety monitoring, then exit from the study.
arm group label: Ablation procedure
other name: CARTOFINDER™ Workstation, CARTO® 3 EP Navigation System, with CARTOFINDER™ 4D LAT Algorithm installed (CARTOFINDER™ Module)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No