<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/NCT03016169</url>
  </required_header>
  <id_info>
    <org_study_id>SJM-CIP-10120</org_study_id>
    <nct_id>NCT03016169</nct_id>
  </id_info>
  <brief_title>Trifecta™ GT Post Market Clinical Follow-up</brief_title>
  <official_title>Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety and performance of the Trifecta™ GT&#xD;
      (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world&#xD;
      setting. This study is intended to satisfy post-market clinical follow-up requirements of CE&#xD;
      Mark in Europe.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective multi-center evaluation of approximately 350 subjects implanted&#xD;
      with a St. Jude Medical (SJM) Trifecta™ GT valve. It will be conducted in approximately 35&#xD;
      sites worldwide.&#xD;
&#xD;
      Subjects will be followed for 5 years. The total duration of the study is expected to be 6&#xD;
      years, assuming all subjects are enrolled within 1 year of study initiation. To ensure&#xD;
      enrollment balance across sites, no individual site can enroll more than 10% of the sample&#xD;
      size (n=35 subjects) without prior approval from the sponsor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 9, 2017</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Actual">April 25, 2023</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 surgical valve replacement or transcatheter valve-in-valve implantation</measure>
    <time_frame>5 years post implant</time_frame>
    <description>Determined by adverse event reporting</description>
  </primary_outcome>
  <other_outcome>
    <measure>Freedom from all-cause mortality</measure>
    <time_frame>5 years post implant</time_frame>
    <description>Determined by adverse event reporting</description>
  </other_outcome>
  <other_outcome>
    <measure>Freedom from valve related mortality</measure>
    <time_frame>5 years post implant</time_frame>
    <description>Determined by adverse event reporting</description>
  </other_outcome>
  <other_outcome>
    <measure>Freedom from structural valve deterioration</measure>
    <time_frame>5 years post implant</time_frame>
    <description>Determined by adverse event reporting</description>
  </other_outcome>
  <other_outcome>
    <measure>Freedom from surgical valve replacement or transcatheter valve implantation due to structural valve deterioration</measure>
    <time_frame>5 years post implant</time_frame>
    <description>Determined by adverse event reporting</description>
  </other_outcome>
  <other_outcome>
    <measure>Valve hemodynamic performance</measure>
    <time_frame>Up to 7 days, 6 months, 3 years and 5 years post implant</time_frame>
    <description>Measured by echocardiogram</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">363</enrollment>
  <condition>Aortic Valve Disease</condition>
  <condition>Aortic Valve Disorder</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All subjects will receive the Trifecta GT valve</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trifecta GT (Glide Technology) Valve</intervention_name>
    <description>Surgical aortic valve replacement with Trifecta GT Valve.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is a candidate for surgical aortic valve replacement per current guidelines&#xD;
             and is intended to be implanted with a St. Jude Medical Trifecta GT valve.&#xD;
&#xD;
          2. Subject is of legal age in the country where the subject is enrolled.&#xD;
&#xD;
          3. Subject must be willing and able to provide written informed consent to participate in&#xD;
             this study.&#xD;
&#xD;
          4. Subject must be willing and able to comply with all follow-up requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at&#xD;
             the time of the Trifecta GT valve implantation surgery.&#xD;
&#xD;
          2. Subject has contraindication for cardiac surgery.&#xD;
&#xD;
          3. Subject is pregnant. Pregnancy will be assessed by the subject informing the&#xD;
             physicians.&#xD;
&#xD;
          4. Subject has active endocarditis (subjects who have previously experienced endocarditis&#xD;
             must have two documented negative blood culture results while off antibiotic therapy&#xD;
             prior to the valve implantation surgery).&#xD;
&#xD;
          5. Subject has had a stroke or transient ischemic attack within 6 months prior to the&#xD;
             planned valve implantation surgery.&#xD;
&#xD;
          6. Subject is undergoing renal dialysis.&#xD;
&#xD;
          7. Subject has a history of active drug addiction, active alcohol abuse, or psychiatric&#xD;
             hospital admission for psychosis within the prior 2 years.&#xD;
&#xD;
          8. Subject has a documented thrombus in the left atrium or left ventricle at the time of&#xD;
             the valve implantation surgery.&#xD;
&#xD;
          9. Subject has a left ventricular ejection fraction &lt; 30%.&#xD;
&#xD;
         10. Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject&#xD;
             cannot be enrolled twice in this study).&#xD;
&#xD;
         11. Preoperative evaluation indicates other significant cardiovascular abnormalities such&#xD;
             as aortic dissection or ventricular aneurysm.&#xD;
&#xD;
         12. Subject has a life expectancy less than 2 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Health &amp; Hospitals</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Main Line Health Center/Lankenau Hospital</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centennial Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI St. Luke's Health Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint Luc</name>
      <address>
        <city>Brussels</city>
        <state>Brussels - Capital Region</state>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint John Regional Hospital - New Brunswick Heart Centre</name>
      <address>
        <city>Saint John</city>
        <state>New Brunswick</state>
        <zip>E2L4L2</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>Institut de Cardiologie de Montreal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H1T 1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tartu University Hospital</name>
      <address>
        <city>Tartu</city>
        <zip>50406</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Hopital de Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <state>Brittany</state>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kerckhoff-Klinik gGmbH</name>
      <address>
        <city>Bad Nauheim</city>
        <state>Hesse</state>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus der Barmherzigen Brüder</name>
      <address>
        <city>Trier</city>
        <state>Rhineland-Palatinate</state>
        <zip>54292</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Leipzig GmbH</name>
      <address>
        <city>Leipzig</city>
        <state>Saxony</state>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <state>Thuringia</state>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deutsches Herzzentrum Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>65760</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Harburg</name>
      <address>
        <city>Hamburg</city>
        <zip>21075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Niguarda Ca'Granda</name>
      <address>
        <city>Milano</city>
        <state>Lombardy</state>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp Universitaria Careggi</name>
      <address>
        <city>Firenze</city>
        <state>Tuscany</state>
        <zip>51034</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale dell'Angelo</name>
      <address>
        <city>Mestre</city>
        <state>Veneto</state>
        <zip>30174</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catharina Ziekenhuis</name>
      <address>
        <city>Eindhoven</city>
        <state>Noord-Brabant</state>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralny Szpital Kliniczny MSW w Warszawie</name>
      <address>
        <city>Warsaw</city>
        <state>Mazovia</state>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de São João</name>
      <address>
        <city>Porto</city>
        <zip>4202-451</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario del Vinalopó</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03293</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Son Espases</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Balearic Island</state>
        <zip>07120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plymouth Hospitals NHS Trust - Derriford Hospital</name>
      <address>
        <city>Plymouth</city>
        <state>South West England</state>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Bartholomew's Hospital</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>May 17, 2023</last_update_submitted>
  <last_update_submitted_qc>May 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 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>Aortic Valve Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03016169
org study id: SJM-CIP-10120
nct id: NCT03016169
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The objective of this study is to evaluate the safety and performance of the Trifecta™ GT
      (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world
      setting. This study is intended to satisfy post-market clinical follow-up requirements of CE
      Mark in Europe.
The study is a prospective multi-center evaluation of approximately 350 subjects implanted
      with a St. Jude Medical (SJM) Trifecta™ GT valve. It will be conducted in approximately 35
      sites worldwide.

      Subjects will be followed for 5 years. The total duration of the study is expected to be 6
      years, assuming all subjects are enrolled within 1 year of study initiation. To ensure
      enrollment balance across sites, no individual site can enroll more than 10% of the sample
      size (n=35 subjects) without prior approval from the sponsor.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom from surgical valve replacement or transcatheter valve-in-valve implantation
time frame: 5 years post implant
description: Determined by adverse event reporting
measure: Freedom from all-cause mortality
time frame: 5 years post implant
description: Determined by adverse event reporting
measure: Freedom from valve related mortality
time frame: 5 years post implant
description: Determined by adverse event reporting
measure: Freedom from structural valve deterioration
time frame: 5 years post implant
description: Determined by adverse event reporting
measure: Freedom from surgical valve replacement or transcatheter valve implantation due to structural valve deterioration
time frame: 5 years post implant
description: Determined by adverse event reporting
measure: Valve hemodynamic performance
time frame: Up to 7 days, 6 months, 3 years and 5 years post implant
description: Measured by echocardiogram
arm group label: Treatment
arm group type: Other
description: All subjects will receive the Trifecta GT valve
intervention type: Device
intervention name: Trifecta GT (Glide Technology) Valve
description: Surgical aortic valve replacement with Trifecta GT Valve.
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Belgium
country: Canada
country: Estonia
country: France
country: Germany
country: Italy
country: Netherlands
country: Poland
country: Portugal
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Aortic Valve Disease
sharing ipd: Undecided