<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/NCT03021356</url>
  </required_header>
  <id_info>
    <org_study_id>COTRIP</org_study_id>
    <nct_id>NCT03021356</nct_id>
  </id_info>
  <brief_title>Comparison of TrIfecta and Perimount Magna Ease</brief_title>
  <official_title>Prospective Randomized Comparison of TrIfecta and Perimount Magna Ease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kerckhoff Klinik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kerckhoff Klinik</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical&#xD;
      and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress&#xD;
      echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on&#xD;
      postoperative outcome will be compared using spiroergometry, quality of life questionnaire&#xD;
      and heart failure biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Transprosthetic pressure gradient at stress exercise echocardiography</measure>
    <time_frame>Echo at follow up stress echo (at 10 months)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Transprosthetic pressure gradient at discharge echo</measure>
    <time_frame>Echo at discharge (usually postoperative day 5 to 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left ventricular mass regression calculated by echocardiography (gram)</measure>
    <time_frame>Echo at discharge and at follow up (usually at postoperative day 5 to 7 and at 10 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life using the EQ-5D-3L questionnaire</measure>
    <time_frame>1 to 5 days before surgery and at follow up (10 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BNP plasma level</measure>
    <time_frame>1 to 5 days before surgery and at follow up (10 months)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Aortic Xenograft Hemodynamics</condition>
  <arm_group>
    <arm_group_label>Trifecta aortic xenograft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Trifecta aortic xenograft is implanted in these patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Magna Ease aortic xenograft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Magna Ease aortic xenograft is implanted in these patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aortic xenograft</intervention_name>
    <description>After randomization, the aortic xenograft is implanted in the standard fashion</description>
    <arm_group_label>Magna Ease aortic xenograft</arm_group_label>
    <arm_group_label>Trifecta aortic xenograft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between 18 and 75 years&#xD;
&#xD;
          -  Elective aortic valve replacement in patients with predominant aortic stenosis&#xD;
&#xD;
               -  including concomitant CABG and/or atrial fibrillation ablation and/or&#xD;
                  supracoronary aortic replacement&#xD;
&#xD;
          -  Informed consent including willingness for stress echocardiography, spiroergometry and&#xD;
             quality of life examination after 6 months.&#xD;
&#xD;
          -  Native German speakers (quality of life questionnaire in German language)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Isolated aortic regurgitation&#xD;
&#xD;
          -  Concomitant aortic regurgitation &gt; 2°&#xD;
&#xD;
          -  Endocarditis&#xD;
&#xD;
          -  LVEF &lt;40%&#xD;
&#xD;
          -  Concomitant other valve surgery&#xD;
&#xD;
          -  s/p valve surgery&#xD;
&#xD;
          -  Contraindication for stress echocardiography&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kerckhoff Klinik</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03021356
org study id: COTRIP
nct id: NCT03021356
lead sponsor: 
collaborator: 
has dmc: No
The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical
      and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress
      echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on
      postoperative outcome will be compared using spiroergometry, quality of life questionnaire
      and heart failure biomarkers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Transprosthetic pressure gradient at stress exercise echocardiography
time frame: Echo at follow up stress echo (at 10 months)
measure: Transprosthetic pressure gradient at discharge echo
time frame: Echo at discharge (usually postoperative day 5 to 7)
measure: Left ventricular mass regression calculated by echocardiography (gram)
time frame: Echo at discharge and at follow up (usually at postoperative day 5 to 7 and at 10 months)
measure: Quality of life using the EQ-5D-3L questionnaire
time frame: 1 to 5 days before surgery and at follow up (10 months)
measure: BNP plasma level
time frame: 1 to 5 days before surgery and at follow up (10 months)
arm group label: Trifecta aortic xenograft
arm group type: Active Comparator
description: The Trifecta aortic xenograft is implanted in these patients.
arm group label: Magna Ease aortic xenograft
arm group type: Active Comparator
description: The Magna Ease aortic xenograft is implanted in these patients.
intervention type: Device
intervention name: Aortic xenograft
description: After randomization, the aortic xenograft is implanted in the standard fashion
arm group label: Magna Ease aortic xenograft
arm group label: Trifecta aortic xenograft
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
sharing ipd: No