<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/NCT03232450</url>
  </required_header>
  <id_info>
    <org_study_id>14-005348</org_study_id>
    <nct_id>NCT03232450</nct_id>
  </id_info>
  <brief_title>Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation</brief_title>
  <acronym>PFOCUS</acronym>
  <official_title>PFOCUS Pilot Trial- A Prospective Pilot Trial for PFO ClosUre at the Time of endovaScular Cardiac Electronic Device Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants enrolled in this study will have been diagnosed with patent foramen ovale (PFO)&#xD;
      and have been scheduled to have a cardiovascular implantable electronic device (CIED) such as&#xD;
      a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization&#xD;
      therapy (CRT) device implanted. A PFO is a condition when there is a hole in the septum (the&#xD;
      wall separating the right and left sides) of the heart.&#xD;
&#xD;
      The purpose of this study is to determine whether closing the PFO with the GORE® Cardioform&#xD;
      Septal Occluder in people with an endocardial device leads reduces the risk of recurrent&#xD;
      stroke or imaging-confirmed transient ischemic attack (TIA) compared to not closing the PFO.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No funding or enrollment&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Embolic Brain Lesions Detected on MRI &gt;3 mm</measure>
    <time_frame>1 year post implantation</time_frame>
    <description>The mean number of embolic brain lesions will be calculated at approximately 1 year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Die</measure>
    <time_frame>1 year post implantation</time_frame>
    <description>The mean number of deaths will be calculated at approximately 1 year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Experience a Stroke</measure>
    <time_frame>1 year post implantation</time_frame>
    <description>Stroke is defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects who Experience a Transient Ischemic Attack (TIA)</measure>
    <time_frame>1 year post implantation</time_frame>
    <description>Transient ischemic attack (TIA) is defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Executive Function as Measured by Trail Making Test B</measure>
    <time_frame>baseline, 1 year post implantation</time_frame>
    <description>Trail Making Test B consists of 25 circles including both numbers (1-13) and letters (A-L). The subject draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. The subject is timed as they draw the trail. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average score is 75 seconds; &gt; 273 seconds is considered deficient.&#xD;
Trail Making Test B consists of 25 circles including both numbers (1 - 13) and letters (A - L). The subject draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. The subject is timed as they draw the trail. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average score is 75 seconds; &gt; 273 seconds is considered deficient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Language as Measured by Letter and Category Fluency Test</measure>
    <time_frame>baseline, 1 year post implantation</time_frame>
    <description>The examiner gives the subject a category and ask them to name all the different examples that they can think of from that category in one minute. Examples of categories are animals, fruit, birds, breeds of dog, tools, etc. Subjects are also asked to provide examples that start with a given letter. To score, the examiner counts the number of unique responses for a category or letter for one minute; categories can be averaged together. The higher the score the better the language fluency, the lower the score, the worse the language fluency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Psychomotor Speed as Measured by Trail Making A Test</measure>
    <time_frame>baseline, 1 year post implantation</time_frame>
    <description>Trail Making Test A consists of 25 numbered circles distributed over a sheet of paper. The patient should draw lines to connect the numbers in ascending order. The patient is timed as they draw the trail. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average score is 29 seconds; &gt; 78 seconds is considered deficient.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Foramen Ovale, Patent</condition>
  <arm_group>
    <arm_group_label>PFO Closure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>Subjects will receive 81 mg enteric coated aspirin</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>PFO Closure</arm_group_label>
    <other_name>Acetylsalicylic acid (ASA)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cardiovascular Implantable Device (CIED)</intervention_name>
    <description>All subjects will receive either a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>PFO Closure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Gore Cardioform Septal Occluder</intervention_name>
    <description>The Gore Cardioform Septal Occluder closes the patent foramen ovale (PFO).</description>
    <arm_group_label>PFO Closure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A clinical indication for a transvenous pacemaker or defibrillator implantation,&#xD;
&#xD;
          -  Must have a documented PFO determined from Transthoracic Echocardiogram (TTE)&#xD;
             echocardiographic agitated saline contrast study that is determined to be feasible for&#xD;
             transcatheter closure.&#xD;
&#xD;
          -  The GORE® CARDIOFORM Septal Occluder should only be used in subjects whose vasculature&#xD;
             is adequate to accommodate a 10 Fr delivery sheath (or 12 Fr delivery sheath when a&#xD;
             guidewire is used).&#xD;
&#xD;
          -  All subjects must be able to undergo standardized neurocognitive testing, and&#xD;
             dementia/mental status examination screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a survival expectancy of less than one year.&#xD;
&#xD;
          -  Subjects with an atrial septal defect or shunt that clinically requires closure for&#xD;
             hemodynamic or other purposes.&#xD;
&#xD;
          -  Absence of a clinical indication for a transvenous CIED system.&#xD;
&#xD;
          -  Subjects with any clinical indication mandating anticoagulation.&#xD;
&#xD;
          -  Subjects with previously placed CIED devices will be excluded.&#xD;
&#xD;
          -  Unable to take anti-platelet medications such as aspirin or clopidogrel (Plavix).&#xD;
&#xD;
          -  With anatomy where the GORE® CARDIOFORM Septal Occluder size or position would&#xD;
             interfere with other intracardiac or intravascular structures, such as cardiac valves&#xD;
             or pulmonary veins.&#xD;
&#xD;
          -  With active endocarditis, or other infections producing bacteremia, or with known&#xD;
             sepsis within one month of planned implantation, or any other infection that cannot be&#xD;
             treated successfully prior to device placement.&#xD;
&#xD;
          -  With known intracardiac thrombi.&#xD;
&#xD;
          -  Known pregnancy at the time of automated implantable cardioverter-defibrillator (AICD)&#xD;
             implant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel J Asirvatham</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>March 11, 2020</last_update_submitted>
  <last_update_submitted_qc>March 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Samuel J. Asirvatham</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Foramen Ovale, Patent</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
  </intervention_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/NCT03232450
org study id: 14-005348
nct id: NCT03232450
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Participants enrolled in this study will have been diagnosed with patent foramen ovale (PFO)
      and have been scheduled to have a cardiovascular implantable electronic device (CIED) such as
      a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization
      therapy (CRT) device implanted. A PFO is a condition when there is a hole in the septum (the
      wall separating the right and left sides) of the heart.

      The purpose of this study is to determine whether closing the PFO with the GORE® Cardioform
      Septal Occluder in people with an endocardial device leads reduces the risk of recurrent
      stroke or imaging-confirmed transient ischemic attack (TIA) compared to not closing the PFO.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Embolic Brain Lesions Detected on MRI >3 mm
time frame: 1 year post implantation
description: The mean number of embolic brain lesions will be calculated at approximately 1 year.
measure: Number of Subjects Who Die
time frame: 1 year post implantation
description: The mean number of deaths will be calculated at approximately 1 year.
measure: Number of Subjects Who Experience a Stroke
time frame: 1 year post implantation
description: Stroke is defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.
measure: Number of Subjects who Experience a Transient Ischemic Attack (TIA)
time frame: 1 year post implantation
description: Transient ischemic attack (TIA) is defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.
measure: Change in Executive Function as Measured by Trail Making Test B
time frame: baseline, 1 year post implantation
description: Trail Making Test B consists of 25 circles including both numbers (1-13) and letters (A-L). The subject draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. The subject is timed as they draw the trail. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average score is 75 seconds; > 273 seconds is considered deficient.
Trail Making Test B consists of 25 circles including both numbers (1 - 13) and letters (A - L). The subject draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. The subject is timed as they draw the trail. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average score is 75 seconds; > 273 seconds is considered deficient.
measure: Change in Language as Measured by Letter and Category Fluency Test
time frame: baseline, 1 year post implantation
description: The examiner gives the subject a category and ask them to name all the different examples that they can think of from that category in one minute. Examples of categories are animals, fruit, birds, breeds of dog, tools, etc. Subjects are also asked to provide examples that start with a given letter. To score, the examiner counts the number of unique responses for a category or letter for one minute; categories can be averaged together. The higher the score the better the language fluency, the lower the score, the worse the language fluency.
measure: Change in Psychomotor Speed as Measured by Trail Making A Test
time frame: baseline, 1 year post implantation
description: Trail Making Test A consists of 25 numbered circles distributed over a sheet of paper. The patient should draw lines to connect the numbers in ascending order. The patient is timed as they draw the trail. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average score is 29 seconds; > 78 seconds is considered deficient.
arm group label: PFO Closure
arm group type: Active Comparator
description: Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder.
arm group label: Control
arm group type: Other
description: Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED)
intervention type: Drug
intervention name: Aspirin
description: Subjects will receive 81 mg enteric coated aspirin
arm group label: Control
arm group label: PFO Closure
other name: Acetylsalicylic acid (ASA)
intervention type: Device
intervention name: Cardiovascular Implantable Device (CIED)
description: All subjects will receive either a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
arm group label: Control
arm group label: PFO Closure
intervention type: Device
intervention name: Gore Cardioform Septal Occluder
description: The Gore Cardioform Septal Occluder closes the patent foramen ovale (PFO).
arm group label: PFO Closure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Samuel J Asirvatham
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Samuel J. Asirvatham
investigator title: Principal Investigator
mesh term: Foramen Ovale, Patent
mesh term: Aspirin
sharing ipd: No