<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/NCT02220270</url>
  </required_header>
  <id_info>
    <org_study_id>COM-01 V1.0 17 June 2014</org_study_id>
    <nct_id>NCT02220270</nct_id>
  </id_info>
  <brief_title>Hyperion™ International Registry Trial</brief_title>
  <acronym>COM-01</acronym>
  <official_title>A Prospective, Multi-center Study to Evaluate the Safety and Performance of the Hyperion™ ASD and PDA Closure Systems.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Cardiovascular Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Comed B.V.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>European Cardiovascular Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety, performance and efficacy of the&#xD;
      Hyperion™ Occluder Systems during treatment of ASD and PDA patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2015</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Success of implantation</measure>
    <time_frame>30 days</time_frame>
    <description>Success of implantation without death, stroke, any device embolization, puncture site bleeding requiring surgical repair or blood transfusion and without any other device or procedure related MAE at 30 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Device success</measure>
    <time_frame>6 months</time_frame>
    <description>Device success defined as ASD or PDA closure at 6 months post procedure by a Transthoracic echocardiography (TTE) or a Transesophageal echocardiography (TEE).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Events</measure>
    <time_frame>30 days, 6 and 12 months</time_frame>
    <description>Major Adverse Events at 6 and 12 months defined as composite rate of all death, stroke, any device embolization, puncture site bleeding requiring surgical repair or blood transfusion at discharge and any other device or procedure related MAE.&#xD;
Components of Major Adverse Events at discharge, 30 days, 6, and 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure success</measure>
    <time_frame>6 months</time_frame>
    <description>Procedure success defined as successful deployment of the Hyperion™ Closure System in the patient's ASD and PDA, closure (residual shunt &lt; 3mm) at 6 months.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Atrial Septal Defects</condition>
  <condition>Patent Ductus Arteriosus</condition>
  <arm_group>
    <arm_group_label>patient with PDA or ASD</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ASD and PDA closure</intervention_name>
    <arm_group_label>patient with PDA or ASD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient who comes to hospital for ASD or PDA closure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has ASD or PDA documented by a Transoesophagial echocardiography (TEE) or a&#xD;
             Transthoracic echocardiography (TTE) and indication for closure that is amenable to&#xD;
             treatment with the Hyperion™ ASD or PDA occluder&#xD;
&#xD;
          -  For PDA: Patient age ≥ 1 year old&#xD;
&#xD;
          -  For ASD: Patient weighting ≥15 kg of any age&#xD;
&#xD;
          -  Patient is willing and able to comply with specified follow-up evaluations&#xD;
&#xD;
          -  Patient or legally authorized representative has been informed of the nature of the&#xD;
             study, agrees to its provisions and has been provided written Notice of Informed&#xD;
             Consent, approved by the appropriate Ethics Committee (EC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year&#xD;
             following index procedure. Female subjects of child-bearing potential must have a&#xD;
             negative pregnancy test done within 7 days prior to the index procedure per site&#xD;
             standard test&#xD;
&#xD;
          -  Patient has other medical illness (e.g., cancer, known malignancy, congestive heart&#xD;
             failure, organ transplant recipient or candidate) or known history of substance abuse&#xD;
             (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol,&#xD;
             confound the data interpretation or is associated with a limited life expectancy&#xD;
             (i.e., less than 1 year)&#xD;
&#xD;
          -  Patient has a known hypersensitivity or contraindication to aspirin, heparin, and/or&#xD;
             contrast sensitivity that cannot be adequately pre-medicated&#xD;
&#xD;
          -  Currently participating in another clinical study&#xD;
&#xD;
          -  Active endocarditis, active bacterial infection, or other infection producing&#xD;
             bacteremia or sepsis&#xD;
&#xD;
          -  Congenital or structural heart disease other than ASD or PDA&#xD;
&#xD;
          -  Thrombus at the intended site of implant or documented venous thrombosis in venous&#xD;
             access&#xD;
&#xD;
          -  Severe pulmonary hypertension&#xD;
&#xD;
          -  Vascular anatomy unable to accommodate the appropriate-sized sheath for device&#xD;
             introduction&#xD;
&#xD;
          -  ASD or PDA anatomy non suitable for the Hyperion™ closure device&#xD;
&#xD;
          -  Confinement to bed (increased risk for clot formation)&#xD;
&#xD;
          -  Prior cardiac implantation of cardiac devices for ASD or PDA closure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jean-François Piechaud, MD</last_name>
    <phone>0 60 13 46 20</phone>
    <phone_ext>33</phone_ext>
    <email>jfpiechaud@angio-icps.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Frantz-Fanon</name>
      <address>
        <city>Blida</city>
        <country>Algeria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed Chettibi, MD</last_name>
      <email>med.chettibi@yahoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Radjah Clinic</name>
      <address>
        <city>Setif</city>
        <country>Algeria</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jean-François Peichaud</last_name>
    </contact>
    <investigator>
      <last_name>Jean-François Piechaud</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Médico-chirurgical infantile Bou Ismail</name>
      <address>
        <city>Tipaza</city>
        <country>Algeria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed Touati, MD</last_name>
      <email>mohamedtouati@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Anzhen Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hong Gu, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Children's Medical Center</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Fen Li, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital cardiologique Haut-Leveque (CHU Bordeaux)</name>
      <address>
        <city>Bordeaux</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jean-Benoit Thambo</last_name>
      <email>jean-benoit.thambo@chu-bordeaux.fr</email>
    </contact>
    <investigator>
      <last_name>Jean-Benoit Thambo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Privé Jacques Cartier</name>
      <address>
        <city>Massy</city>
        <zip>91300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-François Piechaud, MD</last_name>
      <email>Piechjfpiechaud@angio-icps.com</email>
    </contact>
    <investigator>
      <last_name>Jean-François Piechaud, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hopital Necker Enfants Malades</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Younes Boudjemline, MD</last_name>
      <email>yboudjemline@yahoo.fr</email>
    </contact>
    <investigator>
      <last_name>Younes Boudjemline, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>American Memorial Hospital</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pierre Mauran</last_name>
      <email>pmauran@chu-reims.fr</email>
    </contact>
    <investigator>
      <last_name>Pierre Mauran, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CardioVascular Center Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60389</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Horst SIEVERT</last_name>
      <email>horstsievertmd@aol.com</email>
    </contact>
    <investigator>
      <last_name>Horst Sievert, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Algeria</country>
    <country>China</country>
    <country>France</country>
    <country>Germany</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 17, 2015</last_update_submitted>
  <last_update_submitted_qc>August 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2015</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>Ductus Arteriosus, Patent</mesh_term>
    <mesh_term>Heart Septal Defects, Atrial</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/NCT02220270
org study id: COM-01 V1.0 17 June 2014
nct id: NCT02220270
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the safety, performance and efficacy of the
      Hyperion™ Occluder Systems during treatment of ASD and PDA patients.
observational model: Cohort
time perspective: Prospective
measure: Success of implantation
time frame: 30 days
description: Success of implantation without death, stroke, any device embolization, puncture site bleeding requiring surgical repair or blood transfusion and without any other device or procedure related MAE at 30 days
measure: Device success
time frame: 6 months
description: Device success defined as ASD or PDA closure at 6 months post procedure by a Transthoracic echocardiography (TTE) or a Transesophageal echocardiography (TEE).
measure: Major Adverse Events
time frame: 30 days, 6 and 12 months
description: Major Adverse Events at 6 and 12 months defined as composite rate of all death, stroke, any device embolization, puncture site bleeding requiring surgical repair or blood transfusion at discharge and any other device or procedure related MAE.
Components of Major Adverse Events at discharge, 30 days, 6, and 12 months.
measure: Procedure success
time frame: 6 months
description: Procedure success defined as successful deployment of the Hyperion™ Closure System in the patient's ASD and PDA, closure (residual shunt < 3mm) at 6 months.
arm group label: patient with PDA or ASD
intervention type: Device
intervention name: ASD and PDA closure
arm group label: patient with PDA or ASD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 90 Years
healthy volunteers: No
last name: Jean-François Piechaud, MD
phone: 0 60 13 46 20
phone ext: 33
email: jfpiechaud@angio-icps.com
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Algeria
country: China
country: France
country: Germany
country: United Kingdom
responsible party type: Sponsor
mesh term: Ductus Arteriosus, Patent
mesh term: Heart Septal Defects, Atrial