<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/NCT04486924</url>
  </required_header>
  <id_info>
    <org_study_id>DOC-150565</org_study_id>
    <nct_id>NCT04486924</nct_id>
  </id_info>
  <brief_title>Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation</brief_title>
  <acronym>GPS-CA</acronym>
  <official_title>Evaluation of the Acute Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kardium Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kardium 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety and acute performance of the Globe® Mapping and Ablation&#xD;
      System with the GPS™ Module intended to conduct electroanatomic mapping and ablation&#xD;
      treatment of subjects with atrial fibrillation (AF).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 5, 2021</start_date>
  <completion_date type="Actual">August 30, 2022</completion_date>
  <primary_completion_date type="Actual">August 30, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute isolation of all clinically relevant pulmonary veins confirmed by entrance block</measure>
    <time_frame>start to end of the procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Procedure time</measure>
    <time_frame>start to end of the procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Catheter dwell time</measure>
    <time_frame>start to end of the procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fluoroscopy time</measure>
    <time_frame>start to end of the procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fluoroscopy dose area product</measure>
    <time_frame>start to end of the procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Primary Adverse Events (PAE) occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure</measure>
    <time_frame>start to seven days after the end of the procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of all serious adverse events occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure</measure>
    <time_frame>start to seven days after the end of the procedure</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Globe Mapping and Ablation System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Globe Mapping and Ablation System</intervention_name>
    <description>Prospective, non-randomized, open-label clinical study.</description>
    <arm_group_label>Globe Mapping and Ablation System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥18 years old and ≤75 years old&#xD;
&#xD;
          2. Symptomatic AF with at least one AF episode electrocardiographically documented within&#xD;
             one (1) year prior to enrolment. Documentation may include diagnosis in the patient&#xD;
             medical files, electrocardiogram (ECG), Trans-telephonic monitoring (TTM), Holter&#xD;
             monitor or telemetry strip.&#xD;
&#xD;
          3. Selected for catheter ablation for the treatment of atrial fibrillation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of previous left atrial ablation or surgical treatment for AF/AFL/AT&#xD;
&#xD;
          2. Contraindication for either catheter ablation or epicardial surgery (including, but&#xD;
             not limited to: previous thoracic radiation, previous perimyocarditis, previous&#xD;
             cardiac tamponade, pleural adhesions, and prior thoracotomy)&#xD;
&#xD;
          3. Presence of LA thrombus by TEE, CT scan, MRI, or angiography&#xD;
&#xD;
          4. Known conditions or anatomical abnormality that may interfere with the device delivery&#xD;
             or positioning (e.g. myxoma, tumour, calcification, venous access path narrowing, or&#xD;
             tortuosity)&#xD;
&#xD;
          5. Planned concomitant cardiac surgery procedures besides AF treatment (valve, coronary,&#xD;
             others)&#xD;
&#xD;
          6. Uncontrolled heart failure or NYHA Class III or IV heart failure&#xD;
&#xD;
          7. Valve repair or replacement or presence of a prosthetic valve&#xD;
&#xD;
          8. Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical&#xD;
             procedure within the past 6 months&#xD;
&#xD;
          9. MI or PCI procedure within 3 months before screening&#xD;
&#xD;
         10. Left Ventricular Ejection Fraction (LVEF) &lt; 40%&#xD;
&#xD;
         11. Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD)&#xD;
&#xD;
         12. Severe pulmonary hypertension or prior pulmonary stenting&#xD;
&#xD;
         13. History of cerebrovascular disease, including stroke or transient ischemic attack&#xD;
             (TIA) within 6 months prior to enrollment&#xD;
&#xD;
         14. Contraindication to anticoagulation (e.g., heparin)&#xD;
&#xD;
         15. History of blood clotting or bleeding disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Southlake Regional Health Centre</last_name>
    <role>Principal Investigator</role>
    <affiliation>596 Davis Dr, Newmarket ON L3Y 2P9, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southlake Regional Health Centre</name>
      <address>
        <city>Newmarket</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</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>
  <!-- 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/NCT04486924
org study id: DOC-150565
nct id: NCT04486924
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will evaluate the safety and acute performance of the Globe® Mapping and Ablation
      System with the GPS™ Module intended to conduct electroanatomic mapping and ablation
      treatment of subjects with atrial fibrillation (AF).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Acute isolation of all clinically relevant pulmonary veins confirmed by entrance block
time frame: start to end of the procedure
measure: Procedure time
time frame: start to end of the procedure
measure: Catheter dwell time
time frame: start to end of the procedure
measure: Fluoroscopy time
time frame: start to end of the procedure
measure: Fluoroscopy dose area product
time frame: start to end of the procedure
measure: Incidence of Primary Adverse Events (PAE) occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure
time frame: start to seven days after the end of the procedure
measure: Incidence of all serious adverse events occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure
time frame: start to seven days after the end of the procedure
arm group label: Globe Mapping and Ablation System
arm group type: Experimental
intervention type: Device
intervention name: Globe Mapping and Ablation System
description: Prospective, non-randomized, open-label clinical study.
arm group label: Globe Mapping and Ablation System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Southlake Regional Health Centre
role: Principal Investigator
affiliation: 596 Davis Dr, Newmarket ON L3Y 2P9, Canada
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Atrial Fibrillation