<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/NCT04433520</url>
  </required_header>
  <id_info>
    <org_study_id>ABT-CIP_10319</org_study_id>
    <nct_id>NCT04433520</nct_id>
  </id_info>
  <brief_title>Trevisio Post-Approval Study</brief_title>
  <acronym>Trevisio PAS</acronym>
  <official_title>Amplatzer™ Trevisio™ Delivery System Post-Approval Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™&#xD;
      Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of&#xD;
      the Amplatzer™ Occluder Devices&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Trevisio PAS study will evaluate the safety and effectiveness of the Amplatzer Trevisio&#xD;
      Delivery System for facilitating percutaneous, transcatheter implantation of the following&#xD;
      Amplatzer Occluder devices: Amplatzer PFO Occluder, Amplatzer Septal Occluder (ASO),&#xD;
      Amplatzer Multi-Fenestrated Septal Occluder &quot;Cribriform&quot; (ASD-MF), Amplatzer Muscular VSD&#xD;
      Occluder (MuscVSD), and Amplatzer Post-Infarct Muscular VSD Occluder (PIVSD). Trevisio PAS&#xD;
      has two separate cohorts. The ASD/PFO cohort will comprise subjects indicated for atrial&#xD;
      septal defect (ASD) closure with either the ASO or ASD-MF devices as well as subjects&#xD;
      indicated for patent foramen ovale (PFO) closure with the Amplatzer PFO Occluder. The VSD&#xD;
      cohort will comprise subjects indicated for ventricular septal defect (VSD) closure with&#xD;
      either the MuscVSD or PIVSD occluders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Anticipated">October 15, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Technical Success -successful deployment and release of at least one device</measure>
    <time_frame>5years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Device- or procedure-related serious adverse events through discharge or 7 days, whichever occurs first</measure>
    <time_frame>5years</time_frame>
    <description>Includes:&#xD;
Cardiac perforation&#xD;
Sustained atrial fibrillation requiring intervention&#xD;
Device thrombus&#xD;
Device erosion&#xD;
Device embolization&#xD;
Vascular complication requiring surgical intervention&#xD;
Device- or procedure related serious adverse event leading to death</description>
  </primary_outcome>
  <other_outcome>
    <measure>Descriptive Endpoints</measure>
    <time_frame>5years</time_frame>
    <description>The number of times the device is recaptured&#xD;
The number of times the device is repositioned&#xD;
Total fluoroscopy time&#xD;
Ease of use - investigators will be asked survey questions about their first experience with the Amplatzer Trevisio Delivery System.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">254</enrollment>
  <condition>PFO - Patent Foramen Ovale</condition>
  <condition>ASD - Atrial Septum Defect</condition>
  <condition>VSD - Muscular Ventricular Septal Defect</condition>
  <condition>PIVSD - Post Infarct Muscular Ventricular Septal Defect</condition>
  <arm_group>
    <arm_group_label>ASD/PFO cohort</arm_group_label>
    <description>Subjects indicated for atrial septal defect (ASD) closure with either the ASO or ASD-MF devices as well as subjects indicated for patent foramen ovale (PFO) closure with the Amplatzer PFO Occluder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VSD cohort</arm_group_label>
    <description>Subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, Amplatzer ASO or Amplatzer Cribriform Occluder</intervention_name>
    <description>Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer PFO Occluder, Amplatzer ASO or Amplatzer Cribriform Occluder.</description>
    <arm_group_label>ASD/PFO cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder</intervention_name>
    <description>Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder.</description>
    <arm_group_label>VSD cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This clinical study will enroll male and female adults and children with a PFO (adults&#xD;
        only), ASD or VSD who are indicated for transcatheter closure. Patients must meet all&#xD;
        general eligibility criteria and provide written informed consent prior to sites conducting&#xD;
        any study-specific procedures not considered standard of care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Patient is indicated for implantation with the Amplatzer Septal Occluder for occlusion&#xD;
             of a secundum atrial septal defect (Note: This does not include the indication for&#xD;
             closure of a fenestration following a fenestrated Fontan procedure) OR subject is&#xD;
             indicated for implantation with the Amplatzer PFO Occluder OR subject is indicated for&#xD;
             implantation with the Amplatzer Muscular VSD Occluder OR subject is indicated for&#xD;
             implantation with the Amplatzer Post-Infarct Muscular VSD Occluder&#xD;
&#xD;
          2. Patient is of legal age and has provided his/her own written, informed consent&#xD;
&#xD;
        OR&#xD;
&#xD;
        Patient is a minor and has provided verbal and/or written informed consent or assent per&#xD;
        local EC requirements, and his/her legally authorized representative, or representatives,&#xD;
        have provided written informed consent on behalf of the minor according to local EC&#xD;
        requirements&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Presence of anatomic or comorbid conditions, or other medical, social, or&#xD;
             psychological conditions that, in the Principal Investigator's opinion, could limit&#xD;
             the subject's ability to participate in the clinical study or to comply with follow-up&#xD;
             requirements.&#xD;
&#xD;
          2. Exclusion Criteria for Patients Undergoing ASD Closure with the Amplatzer ASO or&#xD;
             Amplatzer ASD-MF Occluder&#xD;
&#xD;
               -  Patients known to have extensive congenital cardiac anomaly that can only be&#xD;
                  adequately repaired by cardiac surgery&#xD;
&#xD;
               -  Patients known to have sepsis within 1 month prior to implantation, or any&#xD;
                  systemic infection that cannot be successfully treated prior to device placement&#xD;
&#xD;
               -  Patients known to have demonstrated intracardiac thrombus on echocardiography&#xD;
                  (especially left atrial or left atrial appendage thrombi)&#xD;
&#xD;
               -  Patients whose size or condition (e.g., too small for transesophageal&#xD;
                  echocardiography [TEE] probe, catheter size, vasculature size, active infection)&#xD;
                  would cause the patient to be a poor candidate for cardiac catheterization&#xD;
&#xD;
               -  Patients with defect margins less than 5 mm to the coronary sinus, inferior vena&#xD;
                  cava rim, an atrioventricular valve, or the right upper lobe pulmonary vein&#xD;
&#xD;
          3. Exclusion Criteria for Patients Undergoing PFO Closure&#xD;
&#xD;
               -  Presence of thrombus at the intended site of implant, or documented evidence of&#xD;
                  venous thrombus in the vessels through which access to the defect is gained.&#xD;
                  Thrombus must be ruled out prior to introducing the delivery system.&#xD;
&#xD;
               -  Active endocarditis or other infections producing bacteremia&#xD;
&#xD;
               -  Patients whose vasculature, through which access to the defect is gained, is&#xD;
                  inadequate to accommodate the appropriate sheath size&#xD;
&#xD;
               -  Anatomy in which the Amplatzer™ PFO device size required would interfere with&#xD;
                  other intra-cardiac or intravascular structures, such as valves or pulmonary&#xD;
                  veins&#xD;
&#xD;
               -  Patients with known hypercoagulable states&#xD;
&#xD;
               -  Patients with intra-cardiac mass or vegetation, thrombus, or tumor&#xD;
&#xD;
          4. Exclusion Criteria for Patients Undergoing VSD Closure with the Amplatzer Muscular VSD&#xD;
             Occluder or Amplatzer Post-Infarct Muscular VSD Occluder&#xD;
&#xD;
               -  Body weight &lt;8 kg&#xD;
&#xD;
               -  Tetralogy of Fallot&#xD;
&#xD;
               -  Intracardiac thrombi on echocardiography&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barathi Sethuraman</last_name>
    <role>Study Director</role>
    <affiliation>DVP Global Clinical Affairs Structural Heart</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laetitia Beullens</last_name>
    <phone>+32 277 46 937</phone>
    <email>laetitia.beullens@abbott.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Karine Miquel</last_name>
    <phone>0032 479 600 107</phone>
    <email>karine.miquel@abbott.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Trousseau</name>
      <address>
        <city>Chambray-lès-Tours</city>
        <zip>37170</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christophe Saint Etienne</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Gabriel Montpied</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire Dauphin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Médico Chirurgical Marie Lannelongue</name>
      <address>
        <city>Le Plessis-Robinson</city>
        <zip>92350</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sebastien Hascoet</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHRU Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francois Godart</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Cardiovasculaire et Pneumologique Louis Pradel</name>
      <address>
        <city>Lyon</city>
        <zip>69394</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital d'adulte de la Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caroline Ovaert</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Hopital G. &amp; R. Laënnec</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alban Elouen Baruteau</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Haut Leveque</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zakaria Jalal</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum NRW</name>
      <address>
        <city>Bad Oeynhausen</city>
        <state>Georgstraße 11</state>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephan Schubert</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Deutsches Herzzentrum München des Freistaates Bayern</name>
      <address>
        <city>München</city>
        <state>Lazarettstraße 36</state>
        <zip>80636</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Deutsches Herzzentrum Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephan Schubert, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein Campus Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthias Lutz</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondazione Toscana Gabriele Monasterio Via Aurelia Sud</name>
      <address>
        <city>Massa</city>
        <state>Tuscany</state>
        <zip>54100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giuseppe Santoro</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Monaldi</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gianpiero Gaio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Policlinico San Donato</name>
      <address>
        <city>San Donato Milanese</city>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Amsterdam Academic Medical Centre (AMC)</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca ul.</name>
      <address>
        <city>Katowice</city>
        <state>Silesia</state>
        <zip>40-635</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Grzegorz Smolka</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Uniwersytekie Centrum Kliniczne</name>
      <address>
        <city>Gdańsk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Cardinal Stefan Wyszynski Institute of Cardiology</name>
      <address>
        <city>Warsaw</city>
        <zip>04-628</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marcin Demkow, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manuel Pan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de la Paz - Pediatrico</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Federico Gutierrez Larraya</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de la Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raul Moreno</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stadtspital Triemli</name>
      <address>
        <city>Zürich</city>
        <zip>8063</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>September 15, 2022</last_update_submitted>
  <last_update_submitted_qc>September 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ABT-CIP_10319</keyword>
  <keyword>Amplatzer Trevisio Intravascular Delivery System</keyword>
  <keyword>Amplatzer Occluder devices</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Septal Defects</mesh_term>
    <mesh_term>Foramen Ovale, Patent</mesh_term>
    <mesh_term>Heart Septal Defects, Ventricular</mesh_term>
    <mesh_term>Heart Septal Defects, Atrial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 1, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04433520
org study id: ABT-CIP_10319
nct id: NCT04433520
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™
      Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of
      the Amplatzer™ Occluder Devices
The Trevisio PAS study will evaluate the safety and effectiveness of the Amplatzer Trevisio
      Delivery System for facilitating percutaneous, transcatheter implantation of the following
      Amplatzer Occluder devices: Amplatzer PFO Occluder, Amplatzer Septal Occluder (ASO),
      Amplatzer Multi-Fenestrated Septal Occluder "Cribriform" (ASD-MF), Amplatzer Muscular VSD
      Occluder (MuscVSD), and Amplatzer Post-Infarct Muscular VSD Occluder (PIVSD). Trevisio PAS
      has two separate cohorts. The ASD/PFO cohort will comprise subjects indicated for atrial
      septal defect (ASD) closure with either the ASO or ASD-MF devices as well as subjects
      indicated for patent foramen ovale (PFO) closure with the Amplatzer PFO Occluder. The VSD
      cohort will comprise subjects indicated for ventricular septal defect (VSD) closure with
      either the MuscVSD or PIVSD occluders.
observational model: Other
time perspective: Prospective
measure: Technical Success -successful deployment and release of at least one device
time frame: 5years
measure: Device- or procedure-related serious adverse events through discharge or 7 days, whichever occurs first
time frame: 5years
description: Includes:
Cardiac perforation
Sustained atrial fibrillation requiring intervention
Device thrombus
Device erosion
Device embolization
Vascular complication requiring surgical intervention
Device- or procedure related serious adverse event leading to death
measure: Descriptive Endpoints
time frame: 5years
description: The number of times the device is recaptured
The number of times the device is repositioned
Total fluoroscopy time
Ease of use - investigators will be asked survey questions about their first experience with the Amplatzer Trevisio Delivery System.
arm group label: ASD/PFO cohort
description: Subjects indicated for atrial septal defect (ASD) closure with either the ASO or ASD-MF devices as well as subjects indicated for patent foramen ovale (PFO) closure with the Amplatzer PFO Occluder.
arm group label: VSD cohort
description: Subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders.
intervention type: Device
intervention name: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, Amplatzer ASO or Amplatzer Cribriform Occluder
description: Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer PFO Occluder, Amplatzer ASO or Amplatzer Cribriform Occluder.
arm group label: ASD/PFO cohort
intervention type: Device
intervention name: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
description: Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder.
arm group label: VSD cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Barathi Sethuraman
role: Study Director
affiliation: DVP Global Clinical Affairs Structural Heart
last name: Laetitia Beullens
phone: +32 277 46 937
email: laetitia.beullens@abbott.com
last name: Karine Miquel
phone: 0032 479 600 107
email: karine.miquel@abbott.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
country: France
country: Germany
country: Italy
country: Netherlands
country: Poland
country: Spain
country: Switzerland
responsible party type: Sponsor
mesh term: Heart Septal Defects
mesh term: Foramen Ovale, Patent
mesh term: Heart Septal Defects, Ventricular
mesh term: Heart Septal Defects, Atrial
sharing ipd: No
submitted: June 1, 2023