<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/NCT02979587</url>
  </required_header>
  <id_info>
    <org_study_id>MDT16004CON001</org_study_id>
    <nct_id>NCT02979587</nct_id>
  </id_info>
  <brief_title>The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study</brief_title>
  <official_title>The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Heart Valves</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Cardiovascular</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™&#xD;
      TPV system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The continued clinical experience addendum is a prospective, multi-center, non-randomized,&#xD;
      interventional study to evaluate the safety and effectiveness of the Harmony TPV system. All&#xD;
      implanted subjects will receive the Harmony TPV 22 or Harmony mTPV 25 device. This phase&#xD;
      allows up to 45 subjects implanted with TPV 22 in the United States and Canada, and up to 84&#xD;
      subjects implanted with mTPV 25 in the United States.&#xD;
&#xD;
      The Post Approval Phase (PAS) addendum is a prospective, multi-center, non-randomized,&#xD;
      post-market study to evaluate the safety and effectiveness of the Harmony TPV system in the&#xD;
      United States. All implanted subjects have been implanted with the Harmony TPV 22 or Harmony&#xD;
      mTPV 25 device during the pivotal or CAS phase of the study. The PAS addendum extends&#xD;
      follow-up from five years to ten years for consenting subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">January 2031</completion_date>
  <primary_completion_date type="Actual">July 17, 2020</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>Freedom From Procedure- or Device-related Mortality at 30 Days.</measure>
    <time_frame>30 days</time_frame>
    <description>The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Defined as:&#xD;
Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND-&#xD;
Pulmonary regurgitant fraction as measured by magnetic resonance imaging &lt;20%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR)</measure>
    <time_frame>At exit from catheterization lab/operating room (OR)</time_frame>
    <description>Technical success at exit from catheterization lab/operating room (OR), as defined as:&#xD;
No device- or procedural-related mortality, with&#xD;
Successful access, delivery and retrieval of the delivery system, and&#xD;
Deployment and correct positioning (including minor repositioning if needed) of the single intended device, and&#xD;
No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Success Out to 5 Years</measure>
    <time_frame>5 years</time_frame>
    <description>Device success is defined as:&#xD;
No device- or procedural-related mortality, with&#xD;
Original intended device in place, and&#xD;
No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the catheterization lab), and&#xD;
Intended performance of the device, as defined as:&#xD;
Structural performance: No migration, embolization, detachment, major stent fracture, hemolysis, thrombosis, endocarditis, and&#xD;
Hemodynamic performance: Relief of insufficiency (PR &lt; moderate) without producing the opposite (mean RVOT gradient &gt; 40 mmHg) as measured by continuous wave Doppler, and&#xD;
Absence of para-device complications, as defined by:&#xD;
PVL = moderate, or&#xD;
Erosion, or&#xD;
RVOT or PA rupture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Procedural Success at 30 Days</measure>
    <time_frame>30 days</time_frame>
    <description>Procedural success is defined as:&#xD;
Device success at 30 days, and&#xD;
None of the following device- or procedure-related serious adverse events:&#xD;
Life-threatening major bleed&#xD;
Major vascular or cardiac structural complications required unplanned reintervention or surgery&#xD;
Stage 2 or 3 acute kidney injury (AKI) (includes new dialysis)&#xD;
Pulmonary embolism&#xD;
Severe heart failure (HF) or hypotension requiring IV inotrope, ultrafiltration, or mechanical circulatory support&#xD;
Prolonged intubation &gt;48 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom From TPV Dysfunction Out to 5 Years</measure>
    <time_frame>5 years (5 year data has an anticipated reporting date of April 2025)</time_frame>
    <description>TPV dysfunction is defined as any one of the following:&#xD;
RVOT reoperation for device-related reasons&#xD;
Catheter re-intervention of TPV&#xD;
Hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient &gt;40 mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Safety</measure>
    <time_frame>Ongoing</time_frame>
    <description>All procedure-related serious adverse events. All device-related serious adverse events. Death (all-cause, procedural, and device-related).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterization of Quality of Life Scores Out to 5 Years</measure>
    <time_frame>Baseline, 30 Day, 6 Month, 1 Year, 2 Year, 3 Year</time_frame>
    <description>Quality of life score over time will be assessed by the SF-36 at pre-implant, 1 month post-implant, 6 months post-implant, 1 year post-implant, 2 years post-implant, and 3 years. The analysis cohort will be the implanted &gt; 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterization of Right Ventricle Remodeling Following TPV Implant</measure>
    <time_frame>Baseline, 6 Month</time_frame>
    <description>Right ventricle remodeling will be assessed via CMR at pre-implant and 6 months post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterization of Quality of Life Scores Out to 5 Years</measure>
    <time_frame>4 Year, 5 Year (4 &amp; 5 year data has an anticipated reporting date of April 2025)</time_frame>
    <description>Quality of life score over time will be assessed by the SF-36 at 4 &amp; 5 years. The analysis cohort will be the implanted &gt; 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterization of Right Ventricle Remodeling Following TPV Implant</measure>
    <time_frame>2 Year, 5 Year (2 &amp; 5 year data has an anticipated reporting date of April 2025)</time_frame>
    <description>Right ventricle remodeling will be assessed via CMR at 2 years post- implant and 5 years post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Congenital Heart Disease</condition>
  <condition>Tetrology of Fallot</condition>
  <condition>RVOT Anomaly</condition>
  <condition>Pulmonary Regurgitation</condition>
  <arm_group>
    <arm_group_label>Harmony TPV System</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery Systems</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Harmony TPV System</intervention_name>
    <description>The Harmony™ TPV (Model NTPV0022) is comprised of a 22mm porcine pericardium valve, sewn to a polyester-covered nitinol frame.&#xD;
The Harmony TPV 25 and mTPV 25 (Model HTPV254952 and HTPV254252, respectively) is comprised of a 25mm porcine pericardium valve, sewn to a polyester covered asymmetrical hourglass nitinol frame with larger diameter inflow and outflow as well as shorter length compared to TPV 22 (Harmony TPV 25 Model HTPV254952 is not applicable for Continued Clinical Experience).&#xD;
The Harmony Delivery System (DS) for the TPV 22, TPV 25, and mTPV 25 (NTPVDS0022 and HTPVDS0025) are all 25 Fr delivery systems using a coil loading catheter.</description>
    <arm_group_label>Harmony TPV System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has severe pulmonary regurgitation as assessed via echocardiography or CMR&#xD;
             determined PR fraction &gt;/= 30%&#xD;
&#xD;
          -  Subject has clinical indication for surgical placement of an RV-PA conduit or&#xD;
             bioprosthetic pulmonary valve&#xD;
&#xD;
          -  Subject is willing to consent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically&#xD;
             treated with an RV-to-PA conduit implant&#xD;
&#xD;
          -  RVOT anatomy or morphology that is unfavorable for device anchoring&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  Life expectancy of less than 1 year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John P Cheatham, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ronald Regan UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Children's Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children (SickKids)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cerebral and Cardiovascular Center</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>565-8565</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Japan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>July 16, 2021</results_first_submitted>
  <results_first_submitted_qc>November 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 2, 2021</results_first_posted>
  <last_update_submitted>January 26, 2023</last_update_submitted>
  <last_update_submitted_qc>January 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
    <mesh_term>Pulmonary Valve Insufficiency</mesh_term>
    <mesh_term>Tetralogy of Fallot</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT02979587/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT02979587/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Implanted Pivotal Harmony TPV Subjects</title>
          <description>This study is comprised of a single arm of subjects implanted with the Harmony TPV device during the pivotal study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Catheterized</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Implanted</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Implanted &gt; 24 Hours</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Harmony Pivotal Subjects- Catheterized Cohort</population>
      <group_list>
        <group group_id="B1">
          <title>Implanted Pivotal Harmony TPV Subjects</title>
          <description>This study is comprised of a single arm of subjects implanted with the Harmony TPV device during the pivotal study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.7" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Freedom From Procedure- or Device-related Mortality at 30 Days.</title>
        <description>The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.</description>
        <time_frame>30 days</time_frame>
        <population>The catheterized cohort consists of all subjects who undergo catheterization for possible implantation of the Harmony TPV. The primary safety endpoint population includes all subjects that were catheterized and also had evaluable data at 30 days. Two subjects were exited prior to the 30 day timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Catheterized Cohort</title>
            <description>Subjects included in this analysis were those who were catheterized for a Harmony TPV implant and had evaluable data at 30 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Freedom From Procedure- or Device-related Mortality at 30 Days.</title>
          <description>The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.</description>
          <population>The catheterized cohort consists of all subjects who undergo catheterization for possible implantation of the Harmony TPV. The primary safety endpoint population includes all subjects that were catheterized and also had evaluable data at 30 days. Two subjects were exited prior to the 30 day timepoint.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months</title>
        <description>Defined as:&#xD;
Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND-&#xD;
Pulmonary regurgitant fraction as measured by magnetic resonance imaging &lt;20%</description>
        <time_frame>6 months</time_frame>
        <population>The implanted &gt;24 hours cohort consists of all subjects who have a Harmony TPV implanted which remains implanted for greater than 24 hours.</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted &gt; 24 Hours Cohort</title>
            <description>Subjects included in this analysis were those who were successfully implanted with a Harmony TPV for greater than 24 hours and had evaluable data at 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months</title>
          <description>Defined as:&#xD;
Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND-&#xD;
Pulmonary regurgitant fraction as measured by magnetic resonance imaging &lt;20%</description>
          <population>The implanted &gt;24 hours cohort consists of all subjects who have a Harmony TPV implanted which remains implanted for greater than 24 hours.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR)</title>
        <description>Technical success at exit from catheterization lab/operating room (OR), as defined as:&#xD;
No device- or procedural-related mortality, with&#xD;
Successful access, delivery and retrieval of the delivery system, and&#xD;
Deployment and correct positioning (including minor repositioning if needed) of the single intended device, and&#xD;
No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure</description>
        <time_frame>At exit from catheterization lab/operating room (OR)</time_frame>
        <population>The attempted implant cohort consists of all subjects who undergo catheterization and a Harmony TPV implantation was attempted (Harmony TPV is introduced into the subject's body).</population>
        <group_list>
          <group group_id="O1">
            <title>Attempted Implant Cohort</title>
            <description>Subjects included in this analysis were those who had an attempted Harmony TPV implant</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR)</title>
          <description>Technical success at exit from catheterization lab/operating room (OR), as defined as:&#xD;
No device- or procedural-related mortality, with&#xD;
Successful access, delivery and retrieval of the delivery system, and&#xD;
Deployment and correct positioning (including minor repositioning if needed) of the single intended device, and&#xD;
No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure</description>
          <population>The attempted implant cohort consists of all subjects who undergo catheterization and a Harmony TPV implantation was attempted (Harmony TPV is introduced into the subject's body).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Device Success Out to 5 Years</title>
        <description>Device success is defined as:&#xD;
No device- or procedural-related mortality, with&#xD;
Original intended device in place, and&#xD;
No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the catheterization lab), and&#xD;
Intended performance of the device, as defined as:&#xD;
Structural performance: No migration, embolization, detachment, major stent fracture, hemolysis, thrombosis, endocarditis, and&#xD;
Hemodynamic performance: Relief of insufficiency (PR &lt; moderate) without producing the opposite (mean RVOT gradient &gt; 40 mmHg) as measured by continuous wave Doppler, and&#xD;
Absence of para-device complications, as defined by:&#xD;
PVL = moderate, or&#xD;
Erosion, or&#xD;
RVOT or PA rupture</description>
        <time_frame>5 years</time_frame>
        <posting_date>04/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Procedural Success at 30 Days</title>
        <description>Procedural success is defined as:&#xD;
Device success at 30 days, and&#xD;
None of the following device- or procedure-related serious adverse events:&#xD;
Life-threatening major bleed&#xD;
Major vascular or cardiac structural complications required unplanned reintervention or surgery&#xD;
Stage 2 or 3 acute kidney injury (AKI) (includes new dialysis)&#xD;
Pulmonary embolism&#xD;
Severe heart failure (HF) or hypotension requiring IV inotrope, ultrafiltration, or mechanical circulatory support&#xD;
Prolonged intubation &gt;48 hours</description>
        <time_frame>30 days</time_frame>
        <population>The attempted implant cohort consists of all subjects who undergo catheterization and a Harmony TPV implantation was attempted (Harmony TPV is introduced into the subject's body).</population>
        <group_list>
          <group group_id="O1">
            <title>Attempted Implant Cohort</title>
            <description>Subjects included in this analysis were those who had an attempted Harmony TPV implant.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Procedural Success at 30 Days</title>
          <description>Procedural success is defined as:&#xD;
Device success at 30 days, and&#xD;
None of the following device- or procedure-related serious adverse events:&#xD;
Life-threatening major bleed&#xD;
Major vascular or cardiac structural complications required unplanned reintervention or surgery&#xD;
Stage 2 or 3 acute kidney injury (AKI) (includes new dialysis)&#xD;
Pulmonary embolism&#xD;
Severe heart failure (HF) or hypotension requiring IV inotrope, ultrafiltration, or mechanical circulatory support&#xD;
Prolonged intubation &gt;48 hours</description>
          <population>The attempted implant cohort consists of all subjects who undergo catheterization and a Harmony TPV implantation was attempted (Harmony TPV is introduced into the subject's body).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Freedom From TPV Dysfunction Out to 5 Years</title>
        <description>TPV dysfunction is defined as any one of the following:&#xD;
RVOT reoperation for device-related reasons&#xD;
Catheter re-intervention of TPV&#xD;
Hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient &gt;40 mmHg)</description>
        <time_frame>5 years (5 year data has an anticipated reporting date of April 2025)</time_frame>
        <posting_date>04/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Safety</title>
        <description>All procedure-related serious adverse events. All device-related serious adverse events. Death (all-cause, procedural, and device-related).</description>
        <time_frame>Ongoing</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Characterization of Quality of Life Scores Out to 5 Years</title>
        <description>Quality of life score over time will be assessed by the SF-36 at pre-implant, 1 month post-implant, 6 months post-implant, 1 year post-implant, 2 years post-implant, and 3 years. The analysis cohort will be the implanted &gt; 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.</description>
        <time_frame>Baseline, 30 Day, 6 Month, 1 Year, 2 Year, 3 Year</time_frame>
        <population>Number analyzed differs from overall number analyzed because subjects have either exited or have not yet completed that timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted &gt; 24 Hours Cohort</title>
            <description>Subjects included in this analysis were those who were successfully implanted with a Harmony TPV for greater than 24 hours and had evaluable data at the given timepoint.</description>
          </group>
        </group_list>
        <measure>
          <title>Characterization of Quality of Life Scores Out to 5 Years</title>
          <description>Quality of life score over time will be assessed by the SF-36 at pre-implant, 1 month post-implant, 6 months post-implant, 1 year post-implant, 2 years post-implant, and 3 years. The analysis cohort will be the implanted &gt; 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.</description>
          <population>Number analyzed differs from overall number analyzed because subjects have either exited or have not yet completed that timepoint.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.5" spread="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Day Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.2" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.6" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.6" spread="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Year Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.4" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Year Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.3" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Characterization of Right Ventricle Remodeling Following TPV Implant</title>
        <description>Right ventricle remodeling will be assessed via CMR at pre-implant and 6 months post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).</description>
        <time_frame>Baseline, 6 Month</time_frame>
        <population>Subjects included in this analysis were those who were successfully implanted with a Harmony TPV for greater than 24 hours and had evaluable CMR data at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted &gt; 24 Hours Cohort</title>
            <description>Subjects included in this analysis were those who were successfully implanted with a Harmony TPV for greater than 24 hours and had evaluable data at the given timepoint.</description>
          </group>
        </group_list>
        <measure>
          <title>Characterization of Right Ventricle Remodeling Following TPV Implant</title>
          <description>Right ventricle remodeling will be assessed via CMR at pre-implant and 6 months post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).</description>
          <population>Subjects included in this analysis were those who were successfully implanted with a Harmony TPV for greater than 24 hours and had evaluable CMR data at the given timepoint.</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-implant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="291.5" spread="57.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="223.0" spread="54.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Characterization of Quality of Life Scores Out to 5 Years</title>
        <description>Quality of life score over time will be assessed by the SF-36 at 4 &amp; 5 years. The analysis cohort will be the implanted &gt; 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.</description>
        <time_frame>4 Year, 5 Year (4 &amp; 5 year data has an anticipated reporting date of April 2025)</time_frame>
        <posting_date>04/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Characterization of Right Ventricle Remodeling Following TPV Implant</title>
        <description>Right ventricle remodeling will be assessed via CMR at 2 years post- implant and 5 years post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).</description>
        <time_frame>2 Year, 5 Year (2 &amp; 5 year data has an anticipated reporting date of April 2025)</time_frame>
        <posting_date>04/2025</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Event data are collected through study completion, an average of 5 years</time_frame>
      <desc>Serious Adverse Event:&#xD;
led to death,&#xD;
led to a serious deterioration in the health of the subject, resulting in&#xD;
a life-threatening illness or injury or&#xD;
a permanent impairment of a body structure or a body function or&#xD;
in-patient or prolonged hospitalization or&#xD;
medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function&#xD;
led to foetal distress, death or congenital abnormality/birth defect.</desc>
      <group_list>
        <group group_id="E1">
          <title>Catheterized Cohort</title>
          <description>The catheterized cohort consists of all subjects who undergo catheterization for possible implantation of the Harmony TPV.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Complete Heart Block</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Device Dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="33" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Premature Ventricular Ectopic Beats</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Supraventricular Tachycardia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Tricuspid Regurgitation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Radiation Burn</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device Shape Alteration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Paravalvular Leak</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hemorrhage</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="50"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kathleen Drewiske, Clinical Study Manager</name_or_title>
      <organization>Medtronic</organization>
      <phone>651-788-1645</phone>
      <email>katie.a.drewiske@medtronic.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/NCT02979587
org study id: MDT16004CON001
nct id: NCT02979587
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™
      TPV system.
The continued clinical experience addendum is a prospective, multi-center, non-randomized,
      interventional study to evaluate the safety and effectiveness of the Harmony TPV system. All
      implanted subjects will receive the Harmony TPV 22 or Harmony mTPV 25 device. This phase
      allows up to 45 subjects implanted with TPV 22 in the United States and Canada, and up to 84
      subjects implanted with mTPV 25 in the United States.

      The Post Approval Phase (PAS) addendum is a prospective, multi-center, non-randomized,
      post-market study to evaluate the safety and effectiveness of the Harmony TPV system in the
      United States. All implanted subjects have been implanted with the Harmony TPV 22 or Harmony
      mTPV 25 device during the pivotal or CAS phase of the study. The PAS addendum extends
      follow-up from five years to ten years for consenting subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom From Procedure- or Device-related Mortality at 30 Days.
time frame: 30 days
description: The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.
measure: Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months
time frame: 6 months
description: Defined as:
Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND-
Pulmonary regurgitant fraction as measured by magnetic resonance imaging <20%
measure: Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR)
time frame: At exit from catheterization lab/operating room (OR)
description: Technical success at exit from catheterization lab/operating room (OR), as defined as:
No device- or procedural-related mortality, with
Successful access, delivery and retrieval of the delivery system, and
Deployment and correct positioning (including minor repositioning if needed) of the single intended device, and
No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
measure: Device Success Out to 5 Years
time frame: 5 years
description: Device success is defined as:
No device- or procedural-related mortality, with
Original intended device in place, and
No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the catheterization lab), and
Intended performance of the device, as defined as:
Structural performance: No migration, embolization, detachment, major stent fracture, hemolysis, thrombosis, endocarditis, and
Hemodynamic performance: Relief of insufficiency (PR < moderate) without producing the opposite (mean RVOT gradient > 40 mmHg) as measured by continuous wave Doppler, and
Absence of para-device complications, as defined by:
PVL = moderate, or
Erosion, or
RVOT or PA rupture
measure: Number of Participants With Procedural Success at 30 Days
time frame: 30 days
description: Procedural success is defined as:
Device success at 30 days, and
None of the following device- or procedure-related serious adverse events:
Life-threatening major bleed
Major vascular or cardiac structural complications required unplanned reintervention or surgery
Stage 2 or 3 acute kidney injury (AKI) (includes new dialysis)
Pulmonary embolism
Severe heart failure (HF) or hypotension requiring IV inotrope, ultrafiltration, or mechanical circulatory support
Prolonged intubation >48 hours
measure: Freedom From TPV Dysfunction Out to 5 Years
time frame: 5 years (5 year data has an anticipated reporting date of April 2025)
description: TPV dysfunction is defined as any one of the following:
RVOT reoperation for device-related reasons
Catheter re-intervention of TPV
Hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient >40 mmHg)
measure: Assessment of Safety
time frame: Ongoing
description: All procedure-related serious adverse events. All device-related serious adverse events. Death (all-cause, procedural, and device-related).
measure: Characterization of Quality of Life Scores Out to 5 Years
time frame: Baseline, 30 Day, 6 Month, 1 Year, 2 Year, 3 Year
description: Quality of life score over time will be assessed by the SF-36 at pre-implant, 1 month post-implant, 6 months post-implant, 1 year post-implant, 2 years post-implant, and 3 years. The analysis cohort will be the implanted > 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.
measure: Characterization of Right Ventricle Remodeling Following TPV Implant
time frame: Baseline, 6 Month
description: Right ventricle remodeling will be assessed via CMR at pre-implant and 6 months post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).
measure: Characterization of Quality of Life Scores Out to 5 Years
time frame: 4 Year, 5 Year (4 & 5 year data has an anticipated reporting date of April 2025)
description: Quality of life score over time will be assessed by the SF-36 at 4 & 5 years. The analysis cohort will be the implanted > 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.
measure: Characterization of Right Ventricle Remodeling Following TPV Implant
time frame: 2 Year, 5 Year (2 & 5 year data has an anticipated reporting date of April 2025)
description: Right ventricle remodeling will be assessed via CMR at 2 years post- implant and 5 years post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).
arm group label: Harmony TPV System
arm group type: Other
description: Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery Systems
intervention type: Device
intervention name: Harmony TPV System
description: The Harmony™ TPV (Model NTPV0022) is comprised of a 22mm porcine pericardium valve, sewn to a polyester-covered nitinol frame.
The Harmony TPV 25 and mTPV 25 (Model HTPV254952 and HTPV254252, respectively) is comprised of a 25mm porcine pericardium valve, sewn to a polyester covered asymmetrical hourglass nitinol frame with larger diameter inflow and outflow as well as shorter length compared to TPV 22 (Harmony TPV 25 Model HTPV254952 is not applicable for Continued Clinical Experience).
The Harmony Delivery System (DS) for the TPV 22, TPV 25, and mTPV 25 (NTPVDS0022 and HTPVDS0025) are all 25 Fr delivery systems using a coil loading catheter.
arm group label: Harmony TPV System
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: John P Cheatham, MD
role: Principal Investigator
affiliation: Nationwide Children's Hospital
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country: Canada
country: Japan
country: United States
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
mesh term: Pulmonary Valve Insufficiency
mesh term: Tetralogy of Fallot
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