<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/NCT01707927</url>
  </required_header>
  <id_info>
    <org_study_id>2011/2596/REK</org_study_id>
    <nct_id>NCT01707927</nct_id>
  </id_info>
  <brief_title>Comparison of Two Biological Aortic Valves. Mosaic Ultra and Trifecta.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparing two biological valves in a prospective randomized study. Mosaic Ultra and Trifecta.&#xD;
      The investigators are looking at EOA and the Pressure Gradients over the valve by patients&#xD;
      with the same annulus measured by a hegar dilatator.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2015</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>Pressure gradients</measure>
    <time_frame>240 days</time_frame>
    <description>Investigators want too look at the effient opening area and pressure gradients of the two valves we are implanting on patients with the same size of the annulus.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>Trifecta</arm_group_label>
    <description>Degenerated aortic valve with indication for aortic valve replacement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mosaic Ultra</arm_group_label>
    <description>Need a aortic valve replacement</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients operated elektively for aortic valve disease with the need of a biological valve&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aortic valve disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant&#xD;
&#xD;
          2. Breast feeding&#xD;
&#xD;
          3. Aortic valve bigger than 23 mm&#xD;
&#xD;
          4. Endocarditis&#xD;
&#xD;
          5. EF &lt; 50%&#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>Bjørn Braathen, MD Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>OUS Thoraxkirurgisk avdeling Ullevål</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Theis Tønnessen, MD Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>OUS thoraxkirurgisk avdeling Ullevål</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bjørn Braathen, MD Ph.D</last_name>
    <phone>0047 22118080</phone>
    <phone_ext>19703</phone_ext>
    <email>uxjrbr@ous-hf.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Theis Tønnessen, MD Ph.d</last_name>
    <phone>0047 22118080</phone>
    <phone_ext>15268</phone_ext>
    <email>uxthto@ous-hf.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Oslo university hospital, Thoracic departement</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bjørn Braathen, MD. PhD</last_name>
      <phone>004722118080</phone>
      <email>uxjrbr@uus-hf.no</email>
    </contact>
    <contact_backup>
      <last_name>Theis Tønnessen, MD, PhD</last_name>
      <phone>004722118080</phone>
      <email>uxthto@uus-hf.no</email>
    </contact_backup>
    <investigator>
      <last_name>Bjørn Braathen, MD-PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>October 12, 2014</last_update_submitted>
  <last_update_submitted_qc>October 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Bjørn Braathen</investigator_full_name>
    <investigator_title>MD. Ph.D</investigator_title>
  </responsible_party>
  <keyword>EOA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</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/NCT01707927
org study id: 2011/2596/REK
nct id: NCT01707927
lead sponsor: 
has dmc: No
Comparing two biological valves in a prospective randomized study. Mosaic Ultra and Trifecta.
      The investigators are looking at EOA and the Pressure Gradients over the valve by patients
      with the same annulus measured by a hegar dilatator.
observational model: Cohort
time perspective: Prospective
measure: Pressure gradients
time frame: 240 days
description: Investigators want too look at the effient opening area and pressure gradients of the two valves we are implanting on patients with the same size of the annulus.
arm group label: Trifecta
description: Degenerated aortic valve with indication for aortic valve replacement
arm group label: mosaic Ultra
description: Need a aortic valve replacement
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bjørn Braathen, MD Ph.D
role: Principal Investigator
affiliation: OUS Thoraxkirurgisk avdeling Ullevål
last name: Theis Tønnessen, MD Ph.D
role: Study Director
affiliation: OUS thoraxkirurgisk avdeling Ullevål
last name: Bjørn Braathen, MD Ph.D
phone: 0047 22118080
phone ext: 19703
email: uxjrbr@ous-hf.no
last name: Theis Tønnessen, MD Ph.d
phone: 0047 22118080
phone ext: 15268
email: uxthto@ous-hf.no
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Bjørn Braathen
investigator title: MD. Ph.D
mesh term: Aortic Valve Stenosis