<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/NCT02987387</url>
  </required_header>
  <id_info>
    <org_study_id>2015-10</org_study_id>
    <nct_id>NCT02987387</nct_id>
  </id_info>
  <brief_title>COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction</brief_title>
  <official_title>New Enrollment SAPIEN XT Post-Approval Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Edwards Lifesciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT&#xD;
      Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular&#xD;
      outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market&#xD;
      setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective, non-randomized, multi-center clinical study to assess the safety&#xD;
      and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional&#xD;
      RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by&#xD;
      transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of&#xD;
      ≥ 35 mmHg by TTE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Anticipated">September 2025</completion_date>
  <primary_completion_date type="Actual">August 9, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from device- or procedure-related death or reintervention</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decrease in pulmonary regurgitation to mild or less for regurgitant lesions</measure>
    <time_frame>1 year</time_frame>
    <description>Assessed via transthoracic echocardiogram (TTE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions</measure>
    <time_frame>1 year</time_frame>
    <description>Assessed via TTE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Success</measure>
    <time_frame>48 Hours Prior to Discharge</time_frame>
    <description>Device Success is a composite of:&#xD;
Deployment of the valve to the target area, and&#xD;
Removal of the delivery catheter out of the body, and&#xD;
Improvement in pulmonary regurgitation to mild or less per the earliest evaluable TTE.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">57</enrollment>
  <condition>Pulmonary Valve Insufficiency</condition>
  <condition>Pulmonary Valve Stenosis</condition>
  <condition>Heart Defects, Congenital</condition>
  <condition>Congenital Abnormalities</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Heart Diseases</condition>
  <arm_group>
    <arm_group_label>TPVI</arm_group_label>
    <description>Transcatheter Pulmonary Valve Implantation with the SAPIEN XT THV</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SAPIEN XT THV</intervention_name>
    <description>SAPIEN XT THV will be implanted in the pulmonic position.</description>
    <arm_group_label>TPVI</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow&#xD;
        tract (RVOT) conduit with a clinical indication for intervention.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient has a dysfunctional, non-compliant RVOT conduit.&#xD;
&#xD;
          2. The patient/patient's legally authorized representative has been informed of the&#xD;
             nature of the study, agrees to its provisions and has provided written informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to tolerate an anticoagulation/antiplatelet regimen&#xD;
&#xD;
          2. Active bacterial endocarditis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's National Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Children's Hospital</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Michigan</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Heart Center Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newark Beth Israel Medical Center</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Beth Israel</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>October 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tetralogy of Fallot</keyword>
  <keyword>Aortic Valve Defect/Disease Resulting in Ross Procedure</keyword>
  <keyword>Transcatheter pulmonary valve implantation</keyword>
  <keyword>Transcatheter pulmonary valve replacement</keyword>
  <keyword>Pulmonary Atresia</keyword>
  <keyword>Pulmonary Stenosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
    <mesh_term>Pulmonary Valve Insufficiency</mesh_term>
    <mesh_term>Pulmonary Valve Stenosis</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02987387
org study id: 2015-10
nct id: NCT02987387
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT
      Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular
      outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market
      setting.
The study is a prospective, non-randomized, multi-center clinical study to assess the safety
      and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional
      RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by
      transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of
      ≥ 35 mmHg by TTE.
observational model: Cohort
time perspective: Prospective
measure: Freedom from device- or procedure-related death or reintervention
time frame: 1 year
measure: Decrease in pulmonary regurgitation to mild or less for regurgitant lesions
time frame: 1 year
description: Assessed via transthoracic echocardiogram (TTE)
measure: Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions
time frame: 1 year
description: Assessed via TTE
measure: Device Success
time frame: 48 Hours Prior to Discharge
description: Device Success is a composite of:
Deployment of the valve to the target area, and
Removal of the delivery catheter out of the body, and
Improvement in pulmonary regurgitation to mild or less per the earliest evaluable TTE.
arm group label: TPVI
description: Transcatheter Pulmonary Valve Implantation with the SAPIEN XT THV
intervention type: Device
intervention name: SAPIEN XT THV
description: SAPIEN XT THV will be implanted in the pulmonic position.
arm group label: TPVI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
mesh term: Pulmonary Valve Insufficiency
mesh term: Pulmonary Valve Stenosis
mesh term: Congenital Abnormalities
sharing ipd: No