<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/NCT03796442</url>
  </required_header>
  <id_info>
    <org_study_id>D-1812-024-991</org_study_id>
    <nct_id>NCT03796442</nct_id>
  </id_info>
  <brief_title>Comparison of Two Pericardial Bioprostheses in AVR</brief_title>
  <official_title>Early and 1-year Hemodynamic Performance and Clinical Outcomes After Aortic Valve Replacement Using Two Pericardial Bioprostheses: A Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of the study is to compare early and 1-year hemodynamic performance and clinical&#xD;
      outcomes after aortic valve replacement using two pericardial bioprosthesis, Avalus and&#xD;
      Carpentier Edwards Perimount Magna Ease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial was designed as a multicenter randomized, controlled trial to recruit 386 patients&#xD;
      who undergo aortic valve replacement with pericardial bioprosthesis. Patients were randomized&#xD;
      by use of a randomization table. Bioprosthesis was chosen between Avalus or Carpentier&#xD;
      Edwards Perimount Magna Ease according to the randomization result. The primary end point is&#xD;
      postoperative 1-year transvalvular mean pressure gradient. The secondary end points are&#xD;
      postoperative 1-year effective orifice area, operative mortality, operative morbidities,&#xD;
      1-year overall survival, 1-year freedom from cardiac death and 1-year freedom from&#xD;
      valve-related events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 13, 2021</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>Transvalvular Mean Pressure Gradient (mPG)</measure>
    <time_frame>at postoperative 1 year</time_frame>
    <description>transvalvular mean pressure gradient measured by trans-thoracic echocardiography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effective Orifice Area (EOA)</measure>
    <time_frame>at postoperative 1 year</time_frame>
    <description>effective orifice area measured by trans-thoracic echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Op Mortality</measure>
    <time_frame>at postoperative 30 days or at the time of discharge</time_frame>
    <description>any death within 30 days after surgery or during the same hospital admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Op Morbidities</measure>
    <time_frame>at postoperative 1 year</time_frame>
    <description>low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All-cause Mortality</measure>
    <time_frame>at postoperative 1 year</time_frame>
    <description>patients who died from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Cardiac Death</measure>
    <time_frame>at postoperative 1 year</time_frame>
    <description>Any death related to cardiac events, including sudden death during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Aortic Valve-related Events</measure>
    <time_frame>at postoperative 1 year</time_frame>
    <description>valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Aortic Valve Disease</condition>
  <arm_group>
    <arm_group_label>AVALUS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients who will undergo aortic valve replacement with Avalus bioprosthesis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CEPME group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AVR with AVALUS</intervention_name>
    <description>aortic valve replacement with AVALUS bioprosthesis</description>
    <arm_group_label>AVALUS group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AVR with CEPME</intervention_name>
    <description>aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis</description>
    <arm_group_label>CEPME group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who are going to undergo aortic valve replacement with bioprosthesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  heart failure with severe LV dysfunction (LV EF &lt;30%)&#xD;
&#xD;
          -  active infective endocarditis&#xD;
&#xD;
          -  with other critical cardiovascular disease (e.g. acute aortic dissection)&#xD;
&#xD;
          -  with other critical comorbities by which the expected life span is less than 1 year&#xD;
&#xD;
          -  inadequate participant by the researcher's discretion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ho Young Hwang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <results_first_submitted>October 31, 2022</results_first_submitted>
  <results_first_submitted_qc>January 20, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 8, 2023</results_first_posted>
  <last_update_submitted>January 20, 2023</last_update_submitted>
  <last_update_submitted_qc>January 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Ho Young Hwang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>aortic valve replacement</keyword>
  <keyword>bioprosthesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be shared because it is not allowed by our institutional IRB.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03796442/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03796442/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AVALUS Group</title>
          <description>patients who will undergo aortic valve replacement with Avalus bioprosthesis&#xD;
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis</description>
        </group>
        <group group_id="P2">
          <title>CEPME Group</title>
          <description>patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis&#xD;
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AVALUS Group</title>
          <description>patients who will undergo aortic valve replacement with Avalus bioprosthesis&#xD;
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis</description>
        </group>
        <group group_id="B2">
          <title>CEPME Group</title>
          <description>patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis&#xD;
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="70"/>
            <count group_id="B2" value="70"/>
            <count group_id="B3" value="140"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.4" spread="5.5"/>
                    <measurement group_id="B2" value="74.3" spread="6.9"/>
                    <measurement group_id="B3" value="72.8" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.8" spread="3.4"/>
                    <measurement group_id="B2" value="24.4" spread="2.8"/>
                    <measurement group_id="B3" value="24.6" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body surface area</title>
          <units>m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.64" spread="0.18"/>
                    <measurement group_id="B2" value="1.65" spread="0.15"/>
                    <measurement group_id="B3" value="1.65" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes mellitus</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypertension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dyslipidemia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Chronic obstructive pulmonary disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stroke</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Chronic kidney disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Peripheral vascular disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Atrial fibrillation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Reoperation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>EuroSCORE II</title>
          <description>The EuroSCORE II (European System for Cardiac Operative Risk Evaluation) is a prognostic scoring system developed in Europe for patients undergoing cardiac surgery. It calculates the risk of in-hospital mortality after major cardiac surgery. The scale ranges from 0 to 100. Higher value of the EuroSCORE II represents that the patient is predicted to have a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.87" spread="1.41"/>
                    <measurement group_id="B2" value="2.11" spread="1.67"/>
                    <measurement group_id="B3" value="1.99" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Transvalvular Mean Pressure Gradient (mPG)</title>
        <description>transvalvular mean pressure gradient measured by trans-thoracic echocardiography</description>
        <time_frame>at postoperative 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AVALUS Group</title>
            <description>patients who will undergo aortic valve replacement with Avalus bioprosthesis&#xD;
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis</description>
          </group>
          <group group_id="O2">
            <title>CEPME Group</title>
            <description>patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis&#xD;
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis</description>
          </group>
        </group_list>
        <measure>
          <title>Transvalvular Mean Pressure Gradient (mPG)</title>
          <description>transvalvular mean pressure gradient measured by trans-thoracic echocardiography</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1" spread="4.3"/>
                    <measurement group_id="O2" value="13.9" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that the AvalusTM was inferior to the CEPME based on the AVMPG at 1-year echocardiographic follow-up, with a non-inferiority margin of 3mmHg. The result for the primary endpoint was presented with 97.5% one-sided confidence interval for mean difference between groups. The non-inferiority test was performed using a t-test which compared mean difference between groups with the non-inferiority margin under the one-sided significance level of 0.025.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The study was designed to have 80% power to detect 1-year AVMPG of 12.6±4.3mmHg for the study prosthesis and 11.9±4.3mmHg for the control prosthesis, with a 1-sided type I error of 2.5% and a noninferiority margin of 3mmHg. The noninferiority margin was determined by the values of 15mmHg for AVMPG of clinically significant aortic stenosis and 12mmHg for AVMPG of the control prosthesis.</non_inferiority_desc>
            <p_value>0.0004</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effective Orifice Area (EOA)</title>
        <description>effective orifice area measured by trans-thoracic echocardiography</description>
        <time_frame>at postoperative 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AVALUS Group</title>
            <description>patients who will undergo aortic valve replacement with Avalus bioprosthesis&#xD;
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis</description>
          </group>
          <group group_id="O2">
            <title>CEPME Group</title>
            <description>patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis&#xD;
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis</description>
          </group>
        </group_list>
        <measure>
          <title>Effective Orifice Area (EOA)</title>
          <description>effective orifice area measured by trans-thoracic echocardiography</description>
          <units>cm2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.48" spread="0.39"/>
                    <measurement group_id="O2" value="1.53" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Op Mortality</title>
        <description>any death within 30 days after surgery or during the same hospital admission</description>
        <time_frame>at postoperative 30 days or at the time of discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AVALUS Group</title>
            <description>patients who will undergo aortic valve replacement with Avalus bioprosthesis&#xD;
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis</description>
          </group>
          <group group_id="O2">
            <title>CEPME Group</title>
            <description>patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis&#xD;
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Op Mortality</title>
          <description>any death within 30 days after surgery or during the same hospital admission</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Op Morbidities</title>
        <description>low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection</description>
        <time_frame>at postoperative 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AVALUS Group</title>
            <description>patients who will undergo aortic valve replacement with Avalus bioprosthesis&#xD;
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis</description>
          </group>
          <group group_id="O2">
            <title>CEPME Group</title>
            <description>patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis&#xD;
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Op Morbidities</title>
          <description>low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Postoperative atrial fibrillation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Respiratory complication</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Acute kidney injury</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Stroke</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Low cardiac output</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Complete atrioventricular block</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bleeding reoperation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mediastinitis</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Infective endocarditis</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No complication</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All-cause Mortality</title>
        <description>patients who died from any cause</description>
        <time_frame>at postoperative 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AVALUS Group</title>
            <description>patients who will undergo aortic valve replacement with Avalus bioprosthesis&#xD;
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis</description>
          </group>
          <group group_id="O2">
            <title>CEPME Group</title>
            <description>patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis&#xD;
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All-cause Mortality</title>
          <description>patients who died from any cause</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Cardiac Death</title>
        <description>Any death related to cardiac events, including sudden death during follow-up</description>
        <time_frame>at postoperative 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AVALUS Group</title>
            <description>patients who will undergo aortic valve replacement with Avalus bioprosthesis&#xD;
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis</description>
          </group>
          <group group_id="O2">
            <title>CEPME Group</title>
            <description>patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis&#xD;
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Cardiac Death</title>
          <description>Any death related to cardiac events, including sudden death during follow-up</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Aortic Valve-related Events</title>
        <description>valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation</description>
        <time_frame>at postoperative 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AVALUS Group</title>
            <description>patients who will undergo aortic valve replacement with Avalus bioprosthesis&#xD;
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis</description>
          </group>
          <group group_id="O2">
            <title>CEPME Group</title>
            <description>patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis&#xD;
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Aortic Valve-related Events</title>
          <description>valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>AVALUS Group</title>
          <description>patients who will undergo aortic valve replacement with Avalus bioprosthesis&#xD;
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis</description>
        </group>
        <group group_id="E2">
          <title>CEPME Group</title>
          <description>patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis&#xD;
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>cardiac deaths</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>nonstructural valve dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>thromboembolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>bleeding event</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>prosthetic valve endocarditis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>permanent pacemaker implantation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prof. Ho Young Hwang</name_or_title>
      <organization>Seoul National University Hospital</organization>
      <phone>00-82-2-2072-3020</phone>
      <email>scalpel@snu.ac.kr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03796442
org study id: D-1812-024-991
nct id: NCT03796442
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of the study is to compare early and 1-year hemodynamic performance and clinical
      outcomes after aortic valve replacement using two pericardial bioprosthesis, Avalus and
      Carpentier Edwards Perimount Magna Ease.
This trial was designed as a multicenter randomized, controlled trial to recruit 386 patients
      who undergo aortic valve replacement with pericardial bioprosthesis. Patients were randomized
      by use of a randomization table. Bioprosthesis was chosen between Avalus or Carpentier
      Edwards Perimount Magna Ease according to the randomization result. The primary end point is
      postoperative 1-year transvalvular mean pressure gradient. The secondary end points are
      postoperative 1-year effective orifice area, operative mortality, operative morbidities,
      1-year overall survival, 1-year freedom from cardiac death and 1-year freedom from
      valve-related events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Transvalvular Mean Pressure Gradient (mPG)
time frame: at postoperative 1 year
description: transvalvular mean pressure gradient measured by trans-thoracic echocardiography
measure: Effective Orifice Area (EOA)
time frame: at postoperative 1 year
description: effective orifice area measured by trans-thoracic echocardiography
measure: Number of Participants With Op Mortality
time frame: at postoperative 30 days or at the time of discharge
description: any death within 30 days after surgery or during the same hospital admission
measure: Number of Participants With Op Morbidities
time frame: at postoperative 1 year
description: low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection
measure: Number of Participants With All-cause Mortality
time frame: at postoperative 1 year
description: patients who died from any cause
measure: Number of Participants With Cardiac Death
time frame: at postoperative 1 year
description: Any death related to cardiac events, including sudden death during follow-up
measure: Number of Participants With Aortic Valve-related Events
time frame: at postoperative 1 year
description: valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation
arm group label: AVALUS group
arm group type: Experimental
description: patients who will undergo aortic valve replacement with Avalus bioprosthesis
arm group label: CEPME group
arm group type: Active Comparator
description: patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
intervention type: Device
intervention name: AVR with AVALUS
description: aortic valve replacement with AVALUS bioprosthesis
arm group label: AVALUS group
intervention type: Device
intervention name: AVR with CEPME
description: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
arm group label: CEPME group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Ho Young Hwang, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Ho Young Hwang
investigator title: Professor
mesh term: Aortic Valve Disease
sharing ipd: No
ipd description: IPD will not be shared because it is not allowed by our institutional IRB.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 