<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/NCT03828825</url>
  </required_header>
  <id_info>
    <org_study_id>IDFFOP</org_study_id>
    <nct_id>NCT03828825</nct_id>
  </id_info>
  <brief_title>Evaluation of the Efficacy and Safety of a Simplified Procedure for the Percutaneous Closure of the Patent Foramen Ovale</brief_title>
  <acronym>IDFFOP</acronym>
  <official_title>Prospective Evaluation of the Efficacy and Safety of a Simplified Procedure for the Percutaneous Closure of the Patent Foramen Ovale</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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>
      Patent Foramen Ovale, is an embryonic remnant, formed by apposition of the septum primum and&#xD;
      septum secondum composing the interatrial septum. This foramen ovale is permeable during&#xD;
      intra-uterine life and allows inter-auricular communication. It tends to close at birth, due&#xD;
      to increased pressure from the left atrium. However, it remains permeable in almost 25% of&#xD;
      the general population. Several studies have shown that this cardiac &quot;anomaly&quot; associated&#xD;
      with the atrial septum aneurysm (ASA), easily diagnosed by ultrasound, is more common in&#xD;
      patients with cryptogenic stroke. The diagnosis of patent foramen ovale is performed by a&#xD;
      cardiac ultrasound with a &quot;bubble&quot; test: a volume of micro-bubbles obtained by emulsion of&#xD;
      saline (9 ml) and air (1 ml) is injected intravenously. The path of these microbubbles is&#xD;
      observed by trans-thoracic ultrasound and can detect a shunt right / left. This test can be&#xD;
      sensitized by Valsalva maneuver and / or cough. The shunt is quantified by the number of&#xD;
      microbubbles flowing through the right / left shunt: positive diagnosis: more than 3 bubbles&#xD;
      passing; minimal shunt &lt;10 bubbles, moderate shunt between 10 and 30 bubbles, massive shunt&#xD;
      if&gt; 30 bubbles.&#xD;
&#xD;
      Patent Foramen Ovale Closure is an interventional cardiac catheterization procedure by venous&#xD;
      femoral approach. Several clinical trials show that Patent Foramen Ovale closure prevents&#xD;
      stroke recurrence in young people and that this procedure is more effective than antiplatelet&#xD;
      therapy. Nevertheless, an increase in the incidence of peri-procedural atrial fibrillation&#xD;
      has been observed. For some researchers, this would be explained by irritation of the atrial&#xD;
      muscle due to the establishment of the device.&#xD;
&#xD;
      To date, only percutaneous closures made in clinical trials have been evaluated. In fact,&#xD;
      there are no specific recommendations. The use in clinical practice of this percutaneous&#xD;
      treatment therefore requires an evaluation of the indications but also the profile of the&#xD;
      patients to optimize these procedures and reduce the complication rate.&#xD;
&#xD;
      The closure technique and the choice of the size of the prosthesis are not standardized. The&#xD;
      closure is done under trans-esophageal echocardiography (invasive method) or trans-thoracic&#xD;
      echocardiography (non-invasive method) depending on the choice of the practitioner. In CLOSE&#xD;
      study, this rate is not specified. The procedure rate under general anesthesia is 54%. This&#xD;
      category of patients can be assumed to use a trans-esophageal echocardiography.&#xD;
&#xD;
      The absence of specific recommendations concerning the technical modalities of this procedure&#xD;
      lead us to study the closure of Patent Foramen Ovale standardized under trans-thoracic&#xD;
      echocardiography and to evaluate its possible reliefs by avoiding the general anesthesia and&#xD;
      the use of trans-esophageal echocardiography. The objective of the study is to bring elements&#xD;
      of standardization of the technique. As part of a &quot;real life&quot; study, we will evaluate the&#xD;
      success rate of procedure under local anesthesia and under trans-thoracic echocardiography&#xD;
      control. This evaluation will be done by trans-thoracic echocardiography at 3 months, the&#xD;
      re-endothelisation time of the medical device being between 1 and 3 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">April 30, 2027</completion_date>
  <primary_completion_date type="Actual">April 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale</measure>
    <time_frame>Month 3</time_frame>
    <description>Rate of disappearance of shunt Right / Left (D / G) by trans-thoracic echocardiography control</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale</measure>
    <time_frame>during the procedure</time_frame>
    <description>Rate of peri-procedural complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale at 1 month</measure>
    <time_frame>Month 1</time_frame>
    <description>Rate of complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale</measure>
    <time_frame>Year 1</time_frame>
    <description>Rate of complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale</measure>
    <time_frame>Year 3</time_frame>
    <description>Rate of complications MACCE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale</measure>
    <time_frame>Year 5</time_frame>
    <description>Rate of complications MACCE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the frequency of cases where a procedural &quot;switch&quot;</measure>
    <time_frame>during procedure</time_frame>
    <description>Patients number for whom procedural &quot;switch&quot; (trans-thoracic echocardiography control discontinuation with trans-esophageal echocardiography) will be required</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">279</enrollment>
  <condition>Patent Foramen Ovale</condition>
  <arm_group>
    <arm_group_label>Patent Foramen Ovale Closure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The percutaneous closure of Patent Foramen Ovale is realized under trans-thoracic echocardiography control. If necessary, the operator will use trans-esophageal echocardiography to implant the prosthesis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patent Foramen Ovale closure</intervention_name>
    <description>The Patent Foramen Ovale closure is realized under trans-thoracic echocardiography control. If necessary, the operator will use trans-esophageal echocardiography to implant the prosthesis. One day after the procedure, a clinical assessment and an electrocardiogram are performed. At 3 months the consultation corresponds to a trans-thoracic echocardiography validation of the closure accompanied by a &quot;bubble test&quot; (Valsalva maneuver) and a clinical assessment. At 12 months, the visit corresponds to a consultation with a clinical assessment and an electrocardiogram. At 36-months and 60-months, the visits will be done following the on-site visits provided for in the usual care or during a telephone call from the attending cardiologist to retrieve the results of the clinical examination, electrocardiogram and MACCE (major cardiac and cerebral vascular events). A consultation dedicated to the study may be proposed to patients according to what is provided in the usual care.</description>
    <arm_group_label>Patent Foramen Ovale Closure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient whose age ≥ 18 years&#xD;
&#xD;
          -  Patient with cryptogenic ischemic stroke&#xD;
&#xD;
          -  Patient with FOP / ASA in trans-esophageal echocardiography&#xD;
&#xD;
          -  Patient with spontaneous and / or induced Shunt R/L&#xD;
&#xD;
          -  ROPE score&gt; 5&#xD;
&#xD;
          -  Patient with medical insurance&#xD;
&#xD;
          -  Francophone patient&#xD;
&#xD;
          -  Patient giving free, informed and express consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with a stroke with known etiology&#xD;
&#xD;
          -  Patient with atrial fibrillation&#xD;
&#xD;
          -  Patient with emboligenic heart disease&#xD;
&#xD;
          -  Patient with carotid stenosis&#xD;
&#xD;
          -  Patient with infectious endocarditis&#xD;
&#xD;
          -  Patient with uncontrolled hypertension&#xD;
&#xD;
          -  Patient for whom the percutaneous closure of the FOP is performed by a medical device&#xD;
             under evaluation&#xD;
&#xD;
          -  Patient under tutorship or curatorship&#xD;
&#xD;
          -  Patient deprived of liberty&#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>Pryscille KAMTCHUENG, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Hôpital Saint-Joseph</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Chirurgical Marie Lannelongue</name>
      <address>
        <city>Le Plessis-Robinson</city>
        <zip>92350</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint-Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Cardiologique du Nord</name>
      <address>
        <city>Saint-Denis</city>
        <zip>93200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 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>Foramen Ovale, Patent</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/NCT03828825
org study id: IDFFOP
nct id: NCT03828825
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patent Foramen Ovale, is an embryonic remnant, formed by apposition of the septum primum and
      septum secondum composing the interatrial septum. This foramen ovale is permeable during
      intra-uterine life and allows inter-auricular communication. It tends to close at birth, due
      to increased pressure from the left atrium. However, it remains permeable in almost 25% of
      the general population. Several studies have shown that this cardiac "anomaly" associated
      with the atrial septum aneurysm (ASA), easily diagnosed by ultrasound, is more common in
      patients with cryptogenic stroke. The diagnosis of patent foramen ovale is performed by a
      cardiac ultrasound with a "bubble" test: a volume of micro-bubbles obtained by emulsion of
      saline (9 ml) and air (1 ml) is injected intravenously. The path of these microbubbles is
      observed by trans-thoracic ultrasound and can detect a shunt right / left. This test can be
      sensitized by Valsalva maneuver and / or cough. The shunt is quantified by the number of
      microbubbles flowing through the right / left shunt: positive diagnosis: more than 3 bubbles
      passing; minimal shunt <10 bubbles, moderate shunt between 10 and 30 bubbles, massive shunt
      if> 30 bubbles.

      Patent Foramen Ovale Closure is an interventional cardiac catheterization procedure by venous
      femoral approach. Several clinical trials show that Patent Foramen Ovale closure prevents
      stroke recurrence in young people and that this procedure is more effective than antiplatelet
      therapy. Nevertheless, an increase in the incidence of peri-procedural atrial fibrillation
      has been observed. For some researchers, this would be explained by irritation of the atrial
      muscle due to the establishment of the device.

      To date, only percutaneous closures made in clinical trials have been evaluated. In fact,
      there are no specific recommendations. The use in clinical practice of this percutaneous
      treatment therefore requires an evaluation of the indications but also the profile of the
      patients to optimize these procedures and reduce the complication rate.

      The closure technique and the choice of the size of the prosthesis are not standardized. The
      closure is done under trans-esophageal echocardiography (invasive method) or trans-thoracic
      echocardiography (non-invasive method) depending on the choice of the practitioner. In CLOSE
      study, this rate is not specified. The procedure rate under general anesthesia is 54%. This
      category of patients can be assumed to use a trans-esophageal echocardiography.

      The absence of specific recommendations concerning the technical modalities of this procedure
      lead us to study the closure of Patent Foramen Ovale standardized under trans-thoracic
      echocardiography and to evaluate its possible reliefs by avoiding the general anesthesia and
      the use of trans-esophageal echocardiography. The objective of the study is to bring elements
      of standardization of the technique. As part of a "real life" study, we will evaluate the
      success rate of procedure under local anesthesia and under trans-thoracic echocardiography
      control. This evaluation will be done by trans-thoracic echocardiography at 3 months, the
      re-endothelisation time of the medical device being between 1 and 3 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale
time frame: Month 3
description: Rate of disappearance of shunt Right / Left (D / G) by trans-thoracic echocardiography control
measure: Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale
time frame: during the procedure
description: Rate of peri-procedural complications
measure: Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale at 1 month
time frame: Month 1
description: Rate of complications
measure: Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale
time frame: Year 1
description: Rate of complications
measure: Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale
time frame: Year 3
description: Rate of complications MACCE
measure: Safety of a simplified procedure for the percutaneous closure of the Patent Foramen Ovale
time frame: Year 5
description: Rate of complications MACCE
measure: Evaluation of the frequency of cases where a procedural "switch"
time frame: during procedure
description: Patients number for whom procedural "switch" (trans-thoracic echocardiography control discontinuation with trans-esophageal echocardiography) will be required
arm group label: Patent Foramen Ovale Closure
arm group type: Experimental
description: The percutaneous closure of Patent Foramen Ovale is realized under trans-thoracic echocardiography control. If necessary, the operator will use trans-esophageal echocardiography to implant the prosthesis.
intervention type: Other
intervention name: Patent Foramen Ovale closure
description: The Patent Foramen Ovale closure is realized under trans-thoracic echocardiography control. If necessary, the operator will use trans-esophageal echocardiography to implant the prosthesis. One day after the procedure, a clinical assessment and an electrocardiogram are performed. At 3 months the consultation corresponds to a trans-thoracic echocardiography validation of the closure accompanied by a "bubble test" (Valsalva maneuver) and a clinical assessment. At 12 months, the visit corresponds to a consultation with a clinical assessment and an electrocardiogram. At 36-months and 60-months, the visits will be done following the on-site visits provided for in the usual care or during a telephone call from the attending cardiologist to retrieve the results of the clinical examination, electrocardiogram and MACCE (major cardiac and cerebral vascular events). A consultation dedicated to the study may be proposed to patients according to what is provided in the usual care.
arm group label: Patent Foramen Ovale Closure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pryscille KAMTCHUENG, MD
role: Principal Investigator
affiliation: Fondation Hôpital Saint-Joseph
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Foramen Ovale, Patent