<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/NCT03821129</url>
  </required_header>
  <id_info>
    <org_study_id>GSO 18-01</org_study_id>
    <nct_id>NCT03821129</nct_id>
  </id_info>
  <brief_title>GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study</brief_title>
  <acronym>REDUCE PAS</acronym>
  <official_title>GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>W.L.Gore &amp; Associates</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>W.L.Gore &amp; Associates</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 study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a&#xD;
      post approval setting and evaluate the quality of operator education and training and&#xD;
      transferability of trial experience to a post-market setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A maximum of 636 adult subjects will be enrolled at up to 40 U.S. centers. Subjects will have&#xD;
      follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post&#xD;
      implant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 25, 2019</start_date>
  <completion_date type="Anticipated">December 2029</completion_date>
  <primary_completion_date type="Anticipated">December 2026</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome)</measure>
    <time_frame>24 months</time_frame>
    <description>Proportion of subjects with recurrent ischemic stroke post study device implant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint)</measure>
    <time_frame>30 days</time_frame>
    <description>Device- or procedure- related serious adverse events post study device implant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment</measure>
    <time_frame>12 months</time_frame>
    <description>Complete PFO closure or a trivial or small residual shunt&#xD;
Proportion of subjects with complete PFO closure or a trivial or small residual shunt</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically Significant New Atrial Arrhythmia</measure>
    <time_frame>60 months</time_frame>
    <description>Any new atrial fibrillation or flutter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically Significant New Atrial Arrhythmia by Age</measure>
    <time_frame>60 months</time_frame>
    <description>Any new atrial fibrillation or flutter in patients greater and less than 60 years of age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual Shunt Characterization via assessment of shunt in patients by Echo</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of shunt in patients by Echo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical Success defined as successful delivery and retention of the GSO device based on physician reporting</measure>
    <time_frame>Index procedure</time_frame>
    <description>Successful delivery and retention of the GSO device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural Success defined as successful implantation of the GSO device with no reported in-hospital Serious Adverse Events (SAEs)</measure>
    <time_frame>Enrollment through discharge, approximately 1 day</time_frame>
    <description>Successful implantation of the GSO device with no reported in-hospital SAEs</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">636</enrollment>
  <condition>Stroke</condition>
  <condition>PFO - Patent Foramen Ovale</condition>
  <arm_group>
    <arm_group_label>GORE® CARDIOFORM Septal Occluder</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single Arm Commercially available GORE® CARDIOFORM Septal Occluder</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PFO closure with GORE® CARDIOFORM Septal Occluder</intervention_name>
    <description>PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke</description>
    <arm_group_label>GORE® CARDIOFORM Septal Occluder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined&#xD;
             source (ESUS) verified by a neurologist within the last 365 days prior to enrollment.&#xD;
&#xD;
          -  Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble&#xD;
             study utilizing transesophageal echocardiography (TEE) and/or transcranial Doppler&#xD;
             (TCD), demonstrating spontaneous right-to-left shunting or right-to-left shunting&#xD;
             during Valsalva maneuver.&#xD;
&#xD;
          -  Patient is able to tolerate antiplatelet therapy&#xD;
&#xD;
          -  Note: Additional Inclusion Criteria may apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of or ongoing atrial fibrillation/flutter&#xD;
&#xD;
          -  Other co-morbidities including, but not limited to, mural thrombus, dilated&#xD;
             cardiomyopathy, cardiac prosthetics (valves), severe native valve disease (including&#xD;
             mitral valve stenosis), severe ventricular wall motion abnormalities, aortic&#xD;
             dissection, significant atherosclerosis, vasculitis, pre-existing non-vascular&#xD;
             neurologic disorders, pulmonary arteriovenous malformations, prior intracranial&#xD;
             hemorrhage, severe disability related to prior stroke, autoimmune disorders that would&#xD;
             increase the risk of stroke or thromboembolism, or associated with increased risk of&#xD;
             infection or procedural complications, in the opinion of the investigator, left&#xD;
             ventricular ejection fraction of &lt;40%, coexistent cause or intra-cardiac shunting&#xD;
             (e.g. VSD or ASD)&#xD;
&#xD;
          -  Previous Myocardial Infarction&#xD;
&#xD;
          -  Rankin Scale sore greater than or equal to 3 at the time of procedure&#xD;
&#xD;
          -  Active infection that cannot be treated successfully prior to enrollment&#xD;
&#xD;
          -  Neurological deficits not due to stroke that may affect the patient's neurologic&#xD;
             assessments&#xD;
&#xD;
          -  Evidence of hypercoagulable state, Uncontrolled diabetes mellitus, uncontrolled&#xD;
             systemic hypertension or pulmonary hypertension at the time of screening or procedure&#xD;
&#xD;
          -  Sensitivity or contraindication to all proposed medical treatments or any device&#xD;
             components&#xD;
&#xD;
          -  Pregnant, lactating, or intent on becoming pregnant through 24 months after&#xD;
             enrollment.&#xD;
&#xD;
          -  Indications outside the parameters accepted for placement of GSO, including extensive&#xD;
             congenital cardiac anomalies and defect diameters considered too large for closure&#xD;
             with the device.&#xD;
&#xD;
          -  Atrial septal anatomy that is expected to necessitate placement of more than one GORE®&#xD;
             CARDIOFORM Septal Occluder&#xD;
&#xD;
          -  Need for concomitant procedure(s) that may confound detection of adverse events&#xD;
             related to device placement&#xD;
&#xD;
          -  Note: Additional Exclusion Criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tammy DeLozier</last_name>
    <phone>800-437-8181</phone>
    <email>GSO1801@wlgore.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>St. Mary's Hospital</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85745</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucille Pena</last_name>
    </contact>
    <investigator>
      <last_name>Kapildeo Lotun, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Scripps Health La Jolla</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Catchpole</last_name>
    </contact>
    <investigator>
      <last_name>Matthew Price, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Loma Linda University Health</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Hoff</last_name>
    </contact>
    <investigator>
      <last_name>Jason Hoff, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California - San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Harsh Agrawal</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Santa Barbara Cottage Hospital</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joseph Aragon</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>South Denver Cardiology Associates</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80120</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lee MacDonald</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical Center of the Rockies</name>
      <address>
        <city>Loveland</city>
        <state>Colorado</state>
        <zip>80538</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Justin Strote</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeremy Asnes</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Naples Community Hospital</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathy Byrd</last_name>
    </contact>
    <investigator>
      <last_name>Roberto Cubeddu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Florida</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Snipelisky</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chandanreddy Devireddy</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clifford Kavinsky</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Alexian Brothers Medical Center</name>
      <address>
        <city>Elk Grove Village</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrei Pop, MD</last_name>
    </contact>
    <investigator>
      <last_name>Andrei Pop, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Keith Benzuly</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals &amp; Clinic</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Phillip Horwitz</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Catholic Health Initiatives- Iowa Corp dba Iowa Heart</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Tannenbaum</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ignacio Inglessis-Azuaje</last_name>
    </contact>
    <investigator>
      <last_name>Ignacio Inglessis-Azuaje</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stanley Chetcuti</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Covenant Medical Center, Inc.</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48602</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bashar Al Jayyousi</last_name>
    </contact>
    <investigator>
      <last_name>Firas Alani</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gregory Helmer</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mario Goessl</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Research Foundation SUNY Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vijay Iyer</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center/NYPH</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Sommer</last_name>
    </contact>
    <investigator>
      <last_name>Robert Sommer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Atrium Health</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Schwartz</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Providence Heart &amp; Vascular Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brandon Jones</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bryan Kluck</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Rhodes</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tennova Healthcare</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37934</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Piana</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine-Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guilherme Silva</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Methodist Hospital - Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chun Huie Lin</last_name>
    </contact>
    <investigator>
      <last_name>Chun Huie Lin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Methodist Healthcare Systems of San Antonio d/b/a Methodist Hospital</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jorge Alvarez</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anwar Tandar</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nishtha Sodhi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sentara Cardiovascular Research Institute</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23455</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paul Mahoney</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Multicare Health Tacoma-Multicare Institute for Research &amp; Innovation</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>William Dixon, MD</last_name>
    </contact>
    <investigator>
      <last_name>William Dixon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Health Care, Metro Inc.</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tanvir Bajwa</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin, Inc.</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Cinquegrani</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>June 16, 2023</last_update_submitted>
  <last_update_submitted_qc>June 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Occluder</keyword>
  <keyword>Patent Foramen Ovale</keyword>
  <keyword>PFO</keyword>
  <keyword>Stroke</keyword>
  <keyword>Gore Septal Occluder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Foramen Ovale, Patent</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/NCT03821129
org study id: GSO 18-01
nct id: NCT03821129
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a
      post approval setting and evaluate the quality of operator education and training and
      transferability of trial experience to a post-market setting.
A maximum of 636 adult subjects will be enrolled at up to 40 U.S. centers. Subjects will have
      follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post
      implant.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome)
time frame: 24 months
description: Proportion of subjects with recurrent ischemic stroke post study device implant
measure: Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint)
time frame: 30 days
description: Device- or procedure- related serious adverse events post study device implant
measure: Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment
time frame: 12 months
description: Complete PFO closure or a trivial or small residual shunt
Proportion of subjects with complete PFO closure or a trivial or small residual shunt
measure: Clinically Significant New Atrial Arrhythmia
time frame: 60 months
description: Any new atrial fibrillation or flutter
measure: Clinically Significant New Atrial Arrhythmia by Age
time frame: 60 months
description: Any new atrial fibrillation or flutter in patients greater and less than 60 years of age
measure: Residual Shunt Characterization via assessment of shunt in patients by Echo
time frame: 24 months
description: Assessment of shunt in patients by Echo
measure: Technical Success defined as successful delivery and retention of the GSO device based on physician reporting
time frame: Index procedure
description: Successful delivery and retention of the GSO device
measure: Procedural Success defined as successful implantation of the GSO device with no reported in-hospital Serious Adverse Events (SAEs)
time frame: Enrollment through discharge, approximately 1 day
description: Successful implantation of the GSO device with no reported in-hospital SAEs
arm group label: GORE® CARDIOFORM Septal Occluder
arm group type: Other
description: Single Arm Commercially available GORE® CARDIOFORM Septal Occluder
intervention type: Device
intervention name: PFO closure with GORE® CARDIOFORM Septal Occluder
description: PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke
arm group label: GORE® CARDIOFORM Septal Occluder
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Tammy DeLozier
phone: 800-437-8181
email: GSO1801@wlgore.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Foramen Ovale, Patent
sharing ipd: No