<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/NCT01732835</url>
  </required_header>
  <id_info>
    <org_study_id>TP-01-022</org_study_id>
    <nct_id>NCT01732835</nct_id>
  </id_info>
  <brief_title>The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance</brief_title>
  <official_title>The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biostable Science &amp; Engineering</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biostable Science &amp; Engineering</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This investigation is a prospective, non-randomized, multi-center trial to evaluate the&#xD;
      extended safety and performance of the HAART model 300 annuloplasty ring when used to&#xD;
      surgically repair the aortic valve using a 3-D intra-annular mounting frame.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aortic Regurgitation, (also known as Aortic Insufficiency; AI), is the failure of the aortic&#xD;
      valve to close completely during diastole which causes blood to flow from the aorta back into&#xD;
      the left ventricle. Aortic Regurgitation (AR) is a frequent cause of both disability and&#xD;
      death due to congestive heart failure, primarily in individuals forty or older, but can also&#xD;
      occur in younger populations.&#xD;
&#xD;
      Traditionally management of aortic regurgitation has been by aortic valve replacement,&#xD;
      however, as has been observed in patients who have had mitral valve repair, the option of&#xD;
      maintaining ones native aortic valve versus a replacement, either bioprosthetic or&#xD;
      mechanical, can have added multiple benefits. The advantage of repair is the avoidance of&#xD;
      prosthetic valve-related complications with bioprosthetic valves over 10-15 years or the need&#xD;
      for anticoagulation with mechanical valves and the related problems of this therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implant Procedure Success</measure>
    <time_frame>discharge or 14 days postprocedure, whichever comes first</time_frame>
    <description>Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actuarial Freedom From Clinical Cardiovascular Events</measure>
    <time_frame>6 months</time_frame>
    <description>Freedom from specified clinical cardiovascular events at 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aortic Insufficiency (AI) at 2 Years</measure>
    <time_frame>2 years</time_frame>
    <description>Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New York Heart Association (NYHA) Functional Capacity Classification at 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New York Heart Association (NYHA) Functional Capacity Classification at 2 Years</measure>
    <time_frame>2 years</time_frame>
    <description>Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Gradient - Change From Baseline</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Transthoracic echocardiography parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Gradient - Change From Baseline</measure>
    <time_frame>Baseline and 2 years</time_frame>
    <description>Transthoracic echocardiography parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Gradient - Change From Baseline</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Transthoracic echocardiography parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Gradient - Change From Baseline</measure>
    <time_frame>Baseline and 2 years</time_frame>
    <description>Transthoracic echocardiography parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LV Mass - Change From Baseline</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Left ventricular mass. Transthoracic echocardiography parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LV Mass - Change From Baseline</measure>
    <time_frame>Baseline and 2 years</time_frame>
    <description>Left ventricular mass. Transthoracic echocardiography parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LVID Diastole - Change From Baseline</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Left ventricular internal dimension. Transthoracic echocardiography parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LVID Diastole - Change From Baseline</measure>
    <time_frame>Baseline and 2 years</time_frame>
    <description>Left ventricular internal dimension. Transthoracic echocardiography parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LVID Systole - Change From Baseline</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Left ventricular internal dimension. Transthoracic echocardiography parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LVID Systole - Change From Baseline</measure>
    <time_frame>Baseline and 2 years</time_frame>
    <description>Left ventricular internal dimension. Transthoracic echocardiography parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LV Diastolic Volume - Change From Baseline</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Left ventricular diastolic volume. Transthoracic echocardiography parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LV Diastolic Volume - Change From Baseline</measure>
    <time_frame>Baseline and 2 years</time_frame>
    <description>Left ventricular diastolic volume. Transthoracic echocardiography parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LV Systolic Volume - Change From Baseline</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Left ventricular systolic volume. Transthoracic echocardiography parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LV Systolic Volume - Change From Baseline</measure>
    <time_frame>Baseline and 2 years</time_frame>
    <description>Left ventricular systolic volume. Transthoracic echocardiography parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LVEF - Change From Baseline</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Left ventricular ejection fraction. Transthoracic echocardiography parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LVEF - Change From Baseline</measure>
    <time_frame>Baseline and 2 years</time_frame>
    <description>Left ventricular ejection fraction. Transthoracic echocardiography parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Output - Change From Baseline</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Stroke volume x heart rate. Transthoracic echocardiography parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Output - Change From Baseline</measure>
    <time_frame>Baseline and 2 years</time_frame>
    <description>Stroke volume x heart rate. Transthoracic echocardiography parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Index - Change From Baseline</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Hemodynamic parameter computed as cardiac output divided by body surface area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Index - Change From Baseline</measure>
    <time_frame>Baseline and 2 years</time_frame>
    <description>Hemodynamic parameter computed as cardiac output divided by body surface area</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Aortic Insufficiency</condition>
  <arm_group>
    <arm_group_label>HAART 300 Annuloplasty Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HAART 300 Annuloplasty Device</intervention_name>
    <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
    <arm_group_label>HAART 300 Annuloplasty Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is 18 years of age or older&#xD;
&#xD;
          -  Subject has tri-leaflet aortic valve morphology&#xD;
&#xD;
          -  Subject has documented aortic valve disease which may or may not include:&#xD;
&#xD;
               1. aortic valve insufficiency&#xD;
&#xD;
               2. aortic root pathology&#xD;
&#xD;
               3. pathology of the ascending aorta&#xD;
&#xD;
               4. patients with associated stable one or two vessel coronary disease requiring&#xD;
                  concomitant coronary bypass&#xD;
&#xD;
          -  Subject is willing to comply with specified follow-up evaluations, including&#xD;
             transesophageal echocardiography (TEE) if there are inadequate images by transthoracic&#xD;
             echocardiography (TTE) to assess the aortic valve&#xD;
&#xD;
          -  Subject has reviewed and signed the written informed consent form&#xD;
&#xD;
          -  Subject agrees to return for all follow-up evaluations for the duration of the study&#xD;
             (i.e.,. geographically stable)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has pre-existing valve prosthesis in the aortic position&#xD;
&#xD;
          -  The subject's aortic valve morphology is not tri-leaflet&#xD;
&#xD;
          -  The subject has active endocarditis&#xD;
&#xD;
          -  Heavily calcified valves&#xD;
&#xD;
          -  The subject has mixed stenosis and regurgitation of the aortic valve with predominant&#xD;
             stenosis&#xD;
&#xD;
          -  Leukopenia&#xD;
&#xD;
          -  Acute anemia (Hb &lt; 9mg%)&#xD;
&#xD;
          -  Platelet count &lt;100,000 cell/mm3&#xD;
&#xD;
          -  Need for emergency surgery for any reason&#xD;
&#xD;
          -  History of bleeding diathesis or coagulopathy or the subject refuses blood&#xD;
             transfusions&#xD;
&#xD;
          -  Active infection requiring antibiotic therapy (if temporary illness, subjects may&#xD;
             enroll 4 weeks after discontinuation of antibiotics)&#xD;
&#xD;
          -  Subjects in whom transesophageal echocardiography (TEE) is contraindicated&#xD;
&#xD;
          -  Low Ejection Fraction (EF) EF &lt; 35%&#xD;
&#xD;
          -  Life expectancy &lt; 1 year&#xD;
&#xD;
          -  The subject is or will be participating in a concomitant research study of an&#xD;
             investigational product or has participated in such a study within the 30 days prior&#xD;
             to screening&#xD;
&#xD;
          -  The subject is a minor, an illicit drug user, alcohol abuser, prisoner,&#xD;
             institutionalized, or is unable to give informed consent&#xD;
&#xD;
          -  The subject is pregnant or lactating&#xD;
&#xD;
          -  Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack&#xD;
             (TIA)&#xD;
&#xD;
          -  Myocardial Infarction (MI) within one month of trial inclusion&#xD;
&#xD;
          -  The subject has a known intolerance to titanium or polyester&#xD;
&#xD;
          -  The subject has documented unstable or &gt; 2 vessel coronary disease&#xD;
&#xD;
          -  The subject requires additional valve replacement or valve repair&#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>Dominico Mazzitelli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Munchen Heart Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Clinical and Experimental Medicine</name>
      <address>
        <city>Prague</city>
        <zip>140 21</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>German Heart Center</name>
      <address>
        <city>Berlin</city>
        <zip>80636</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Herz und Gefässchirurgie</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik und Poliklinik für Herz- und Gefäßchirurgie</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hannover Medical School (MHH)</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinik Köln</name>
      <address>
        <city>Köln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Munchen Heart Center</name>
      <address>
        <city>Munchen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Nürnberg Süd</name>
      <address>
        <city>Nürnberg</city>
        <zip>90471</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czech Republic</country>
    <country>Germany</country>
  </location_countries>
  <removed_countries>
    <country>Belgium</country>
  </removed_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <results_first_submitted>October 6, 2016</results_first_submitted>
  <results_first_submitted_qc>December 7, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 31, 2017</results_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aortic Insufficiency (AI) Aortic Regurgitation (AR)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>HAART 300 Annuloplasty Device</title>
          <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>6-month Primary Endpoint</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not receive device</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>2-year Extended Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants with implanted device</population>
      <group_list>
        <group group_id="B1">
          <title>HAART 300 Annuloplasty Device</title>
          <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="49"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.0" spread="13.6"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </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>Czech Republic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Aortic Insufficiency</title>
          <description>Grade assigned to degree of aortic regurgitation determined by core laboratory analysis of echocardiogram: 0=None/trace, 1+=Mild, 2+=Moderate, 3+=Moderate-to-Severe, 4+=Severe</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not evaluable</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>New York Heart Association (NYHA) Functional Capacity</title>
          <description>Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked imitation; Class IV - inability to carry out any physical activity without discomfort</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>I</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>II</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>III</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Peak gradient</title>
          <description>Echocardiographic parameter determined by core laboratory.</description>
          <population>Participants with an echocardiogram evaluable for this measure.</population>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.1" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean gradient</title>
          <description>Echocardiographic parameter determined by core laboratory.</description>
          <population>Participants with an echocardiogram evaluable for this measure.</population>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.5" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Left ventricular (LV) mass</title>
          <description>Left ventricular mass. Echocardiographic parameter determined by core laboratory.</description>
          <population>Participants with an echocardiogram evaluable for this measure.</population>
          <units>g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="244.1" spread="85.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Left ventricular internal dimension (LVID) diastole</title>
          <description>Left ventricular internal dimension. Echocardiographic parameter determined by core laboratory.</description>
          <population>Participants with an echocardiogram evaluable for this measure.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.50" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>LVID systole</title>
          <description>Left ventricular internal dimension. Echocardiographic parameter determined by core laboratory.</description>
          <population>Participants with an echocardiogram evaluable for this measure.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.02" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>LV diastolic volume</title>
          <description>Left ventricular diastolic volume. Echocardiographic parameter determined by core laboratory.</description>
          <population>Participants with an echocardiogram evaluable for this measure.</population>
          <units>ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="155.3" spread="63.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>LV systolic volume</title>
          <description>Left ventricular systolic volume. Echocardiographic parameter determined by core laboratory.</description>
          <population>Participants with an echocardiogram evaluable for this measure.</population>
          <units>ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.5" spread="37.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Left ventricular ejection fraction (LVEF)</title>
          <description>Left ventricular ejection fraction. Echocardiographic parameter determined by core laboratory.</description>
          <population>Participants with an echocardiogram evaluable for this measure.</population>
          <units>%</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.2" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cardiac output</title>
          <description>Echocardiographic parameter determined by core laboratory.</description>
          <population>Participants with an echocardiogram evaluable for this measure.</population>
          <units>l/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.20" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cardiac index</title>
          <description>Cardiac index is the cardiac output divided by body surface area.</description>
          <population>Participants with an echocardiogram evaluable for this measure.</population>
          <units>l/min/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.16" spread="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure</title>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="92.8" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months</title>
        <description>Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)</description>
        <time_frame>6 months</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months</title>
          <description>Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)</description>
          <population>Participants with an echocardiogram evaluable for this measure.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implant Procedure Success</title>
        <description>Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.</description>
        <time_frame>discharge or 14 days postprocedure, whichever comes first</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>Implant Procedure Success</title>
          <description>Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.</description>
          <units>percentage of implant procedures</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.9" lower_limit="86.0" upper_limit="99.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Actuarial Freedom From Clinical Cardiovascular Events</title>
        <description>Freedom from specified clinical cardiovascular events at 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>Actuarial Freedom From Clinical Cardiovascular Events</title>
          <description>Freedom from specified clinical cardiovascular events at 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.6" lower_limit="80.9" upper_limit="98.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure</title>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.6" lower_limit="83.9" upper_limit="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aortic Insufficiency (AI) at 2 Years</title>
        <description>Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)</description>
        <time_frame>2 years</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>Aortic Insufficiency (AI) at 2 Years</title>
          <description>Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)</description>
          <population>Participants with an echocardiogram evaluable for this measure.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>New York Heart Association (NYHA) Functional Capacity Classification at 6 Months</title>
        <description>Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort</description>
        <time_frame>6 months</time_frame>
        <population>Participants with an evaluation of this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>New York Heart Association (NYHA) Functional Capacity Classification at 6 Months</title>
          <description>Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort</description>
          <population>Participants with an evaluation of this measure.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>New York Heart Association (NYHA) Functional Capacity Classification at 2 Years</title>
        <description>Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort</description>
        <time_frame>2 years</time_frame>
        <population>Participants with an evaluation of this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>New York Heart Association (NYHA) Functional Capacity Classification at 2 Years</title>
          <description>Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort</description>
          <population>Participants with an evaluation of this measure.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Gradient - Change From Baseline</title>
        <description>Transthoracic echocardiography parameter</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Gradient - Change From Baseline</title>
          <description>Transthoracic echocardiography parameter</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Gradient - Change From Baseline</title>
        <description>Transthoracic echocardiography parameter</description>
        <time_frame>Baseline and 2 years</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Gradient - Change From Baseline</title>
          <description>Transthoracic echocardiography parameter</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Gradient - Change From Baseline</title>
        <description>Transthoracic echocardiography parameter</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Gradient - Change From Baseline</title>
          <description>Transthoracic echocardiography parameter</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Gradient - Change From Baseline</title>
        <description>Transthoracic echocardiography parameter</description>
        <time_frame>Baseline and 2 years</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Gradient - Change From Baseline</title>
          <description>Transthoracic echocardiography parameter</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LV Mass - Change From Baseline</title>
        <description>Left ventricular mass. Transthoracic echocardiography parameter.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>LV Mass - Change From Baseline</title>
          <description>Left ventricular mass. Transthoracic echocardiography parameter.</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
          <units>g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.5" spread="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LV Mass - Change From Baseline</title>
        <description>Left ventricular mass. Transthoracic echocardiography parameter.</description>
        <time_frame>Baseline and 2 years</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>LV Mass - Change From Baseline</title>
          <description>Left ventricular mass. Transthoracic echocardiography parameter.</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
          <units>g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.4" spread="60.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LVID Diastole - Change From Baseline</title>
        <description>Left ventricular internal dimension. Transthoracic echocardiography parameter.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>LVID Diastole - Change From Baseline</title>
          <description>Left ventricular internal dimension. Transthoracic echocardiography parameter.</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.48" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LVID Diastole - Change From Baseline</title>
        <description>Left ventricular internal dimension. Transthoracic echocardiography parameter.</description>
        <time_frame>Baseline and 2 years</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>LVID Diastole - Change From Baseline</title>
          <description>Left ventricular internal dimension. Transthoracic echocardiography parameter.</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.22" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LVID Systole - Change From Baseline</title>
        <description>Left ventricular internal dimension. Transthoracic echocardiography parameter.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>LVID Systole - Change From Baseline</title>
          <description>Left ventricular internal dimension. Transthoracic echocardiography parameter.</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.48" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LVID Systole - Change From Baseline</title>
        <description>Left ventricular internal dimension. Transthoracic echocardiography parameter.</description>
        <time_frame>Baseline and 2 years</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>LVID Systole - Change From Baseline</title>
          <description>Left ventricular internal dimension. Transthoracic echocardiography parameter.</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.22" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LV Diastolic Volume - Change From Baseline</title>
        <description>Left ventricular diastolic volume. Transthoracic echocardiography parameter.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>LV Diastolic Volume - Change From Baseline</title>
          <description>Left ventricular diastolic volume. Transthoracic echocardiography parameter.</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
          <units>ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.8" spread="49.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LV Diastolic Volume - Change From Baseline</title>
        <description>Left ventricular diastolic volume. Transthoracic echocardiography parameter.</description>
        <time_frame>Baseline and 2 years</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>LV Diastolic Volume - Change From Baseline</title>
          <description>Left ventricular diastolic volume. Transthoracic echocardiography parameter.</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
          <units>ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.9" spread="53.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LV Systolic Volume - Change From Baseline</title>
        <description>Left ventricular systolic volume. Transthoracic echocardiography parameter.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>LV Systolic Volume - Change From Baseline</title>
          <description>Left ventricular systolic volume. Transthoracic echocardiography parameter.</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
          <units>ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.5" spread="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LV Systolic Volume - Change From Baseline</title>
        <description>Left ventricular systolic volume. Transthoracic echocardiography parameter.</description>
        <time_frame>Baseline and 2 years</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>LV Systolic Volume - Change From Baseline</title>
          <description>Left ventricular systolic volume. Transthoracic echocardiography parameter.</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
          <units>ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.1" spread="29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LVEF - Change From Baseline</title>
        <description>Left ventricular ejection fraction. Transthoracic echocardiography parameter.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>LVEF - Change From Baseline</title>
          <description>Left ventricular ejection fraction. Transthoracic echocardiography parameter.</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
          <units>percentage of blood volume</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.49" spread="7.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LVEF - Change From Baseline</title>
        <description>Left ventricular ejection fraction. Transthoracic echocardiography parameter.</description>
        <time_frame>Baseline and 2 years</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>LVEF - Change From Baseline</title>
          <description>Left ventricular ejection fraction. Transthoracic echocardiography parameter.</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
          <units>percentage of blood volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.37" spread="7.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cardiac Output - Change From Baseline</title>
        <description>Stroke volume x heart rate. Transthoracic echocardiography parameter.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Output - Change From Baseline</title>
          <description>Stroke volume x heart rate. Transthoracic echocardiography parameter.</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
          <units>l/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.15" spread="1.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cardiac Output - Change From Baseline</title>
        <description>Stroke volume x heart rate. Transthoracic echocardiography parameter.</description>
        <time_frame>Baseline and 2 years</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Output - Change From Baseline</title>
          <description>Stroke volume x heart rate. Transthoracic echocardiography parameter.</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
          <units>l/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" spread="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cardiac Index - Change From Baseline</title>
        <description>Hemodynamic parameter computed as cardiac output divided by body surface area</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Index - Change From Baseline</title>
          <description>Hemodynamic parameter computed as cardiac output divided by body surface area</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.</population>
          <units>l/min/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.60" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cardiac Index - Change From Baseline</title>
        <description>Hemodynamic parameter computed as cardiac output divided by body surface area</description>
        <time_frame>Baseline and 2 years</time_frame>
        <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
        <group_list>
          <group group_id="O1">
            <title>HAART 300 Annuloplasty Device</title>
            <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Index - Change From Baseline</title>
          <description>Hemodynamic parameter computed as cardiac output divided by body surface area</description>
          <population>Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.</population>
          <units>l/min/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.26" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through 2 years for the 49 participants receiving the implant</time_frame>
      <group_list>
        <group group_id="E1">
          <title>HAART 300 Annuloplasty Device</title>
          <description>Implantation of HAART 300 Annuloplasty Device for aortic valve repair&#xD;
HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>aortic insufficiency</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>arrhythmia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>cardiac decompensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>pericardial effusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>GI bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>reflux esophagitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>endocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>worsening of wound healing disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>loosening of wire cerclages</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>presternal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>lumbago</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>bronchopulmonary infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>pleural effusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>pleuropneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>pneumothorax</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>pulmonary spasticity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>anemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>aortic insufficiency</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>arrhythmia</sub_title>
                <counts group_id="E1" events="23" subjects_affected="20" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>edema</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>pericardial effusion</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>syncope</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>abnormal LDH value</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>hyperthyreosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>increased C-reactive protein</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>bleeding event</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>sternal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>thoracic pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>atelectasis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>pleural effusion</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>pneumothorax</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>respiratory infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </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>Publication by the investigator was not allowed until completion of the trial. All proposed publications must be cleared by unanimous vote of a publication committee consisting of the sponsor and representatives of the study investigators. Publication materials must be submitted for review at least 60 day in advance of publication. The Sponsor may embargo publication for 60 additional days to allow for patent filing or may prevent publication if filling of such application would be premature.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>John Wheeler</name_or_title>
      <organization>Biostable Science and Engineering, Inc.</organization>
      <phone>512-386-1996</phone>
      <email>John.wheeler@biostable-s-e.com</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/NCT01732835
org study id: TP-01-022
nct id: NCT01732835
lead sponsor: 
has dmc: Yes
This investigation is a prospective, non-randomized, multi-center trial to evaluate the
      extended safety and performance of the HAART model 300 annuloplasty ring when used to
      surgically repair the aortic valve using a 3-D intra-annular mounting frame.
Aortic Regurgitation, (also known as Aortic Insufficiency; AI), is the failure of the aortic
      valve to close completely during diastole which causes blood to flow from the aorta back into
      the left ventricle. Aortic Regurgitation (AR) is a frequent cause of both disability and
      death due to congestive heart failure, primarily in individuals forty or older, but can also
      occur in younger populations.

      Traditionally management of aortic regurgitation has been by aortic valve replacement,
      however, as has been observed in patients who have had mitral valve repair, the option of
      maintaining ones native aortic valve versus a replacement, either bioprosthetic or
      mechanical, can have added multiple benefits. The advantage of repair is the avoidance of
      prosthetic valve-related complications with bioprosthetic valves over 10-15 years or the need
      for anticoagulation with mechanical valves and the related problems of this therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure
time frame: 6 months
measure: Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
time frame: 6 months
description: Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
measure: Implant Procedure Success
time frame: discharge or 14 days postprocedure, whichever comes first
description: Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.
measure: Actuarial Freedom From Clinical Cardiovascular Events
time frame: 6 months
description: Freedom from specified clinical cardiovascular events at 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months
measure: Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure
time frame: 2 years
measure: Aortic Insufficiency (AI) at 2 Years
time frame: 2 years
description: Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
measure: New York Heart Association (NYHA) Functional Capacity Classification at 6 Months
time frame: 6 months
description: Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort
measure: New York Heart Association (NYHA) Functional Capacity Classification at 2 Years
time frame: 2 years
description: Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort
measure: Peak Gradient - Change From Baseline
time frame: Baseline and 6 months
description: Transthoracic echocardiography parameter
measure: Peak Gradient - Change From Baseline
time frame: Baseline and 2 years
description: Transthoracic echocardiography parameter
measure: Mean Gradient - Change From Baseline
time frame: Baseline and 6 months
description: Transthoracic echocardiography parameter
measure: Mean Gradient - Change From Baseline
time frame: Baseline and 2 years
description: Transthoracic echocardiography parameter
measure: LV Mass - Change From Baseline
time frame: Baseline and 6 months
description: Left ventricular mass. Transthoracic echocardiography parameter.
measure: LV Mass - Change From Baseline
time frame: Baseline and 2 years
description: Left ventricular mass. Transthoracic echocardiography parameter.
measure: LVID Diastole - Change From Baseline
time frame: Baseline and 6 months
description: Left ventricular internal dimension. Transthoracic echocardiography parameter.
measure: LVID Diastole - Change From Baseline
time frame: Baseline and 2 years
description: Left ventricular internal dimension. Transthoracic echocardiography parameter.
measure: LVID Systole - Change From Baseline
time frame: Baseline and 6 months
description: Left ventricular internal dimension. Transthoracic echocardiography parameter.
measure: LVID Systole - Change From Baseline
time frame: Baseline and 2 years
description: Left ventricular internal dimension. Transthoracic echocardiography parameter.
measure: LV Diastolic Volume - Change From Baseline
time frame: Baseline and 6 months
description: Left ventricular diastolic volume. Transthoracic echocardiography parameter.
measure: LV Diastolic Volume - Change From Baseline
time frame: Baseline and 2 years
description: Left ventricular diastolic volume. Transthoracic echocardiography parameter.
measure: LV Systolic Volume - Change From Baseline
time frame: Baseline and 6 months
description: Left ventricular systolic volume. Transthoracic echocardiography parameter.
measure: LV Systolic Volume - Change From Baseline
time frame: Baseline and 2 years
description: Left ventricular systolic volume. Transthoracic echocardiography parameter.
measure: LVEF - Change From Baseline
time frame: Baseline and 6 months
description: Left ventricular ejection fraction. Transthoracic echocardiography parameter.
measure: LVEF - Change From Baseline
time frame: Baseline and 2 years
description: Left ventricular ejection fraction. Transthoracic echocardiography parameter.
measure: Cardiac Output - Change From Baseline
time frame: Baseline and 6 months
description: Stroke volume x heart rate. Transthoracic echocardiography parameter.
measure: Cardiac Output - Change From Baseline
time frame: Baseline and 2 years
description: Stroke volume x heart rate. Transthoracic echocardiography parameter.
measure: Cardiac Index - Change From Baseline
time frame: Baseline and 6 months
description: Hemodynamic parameter computed as cardiac output divided by body surface area
measure: Cardiac Index - Change From Baseline
time frame: Baseline and 2 years
description: Hemodynamic parameter computed as cardiac output divided by body surface area
arm group label: HAART 300 Annuloplasty Device
arm group type: Experimental
description: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
intervention type: Device
intervention name: HAART 300 Annuloplasty Device
description: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
arm group label: HAART 300 Annuloplasty Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dominico Mazzitelli, MD
role: Principal Investigator
affiliation: Munchen Heart Center
facility: 
facility: 
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country: Czech Republic
country: Germany
country: Belgium
responsible party type: Sponsor
mesh term: Aortic Valve Insufficiency
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 