<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/NCT03003650</url>
  </required_header>
  <id_info>
    <org_study_id>TF89</org_study_id>
    <nct_id>NCT03003650</nct_id>
  </id_info>
  <brief_title>ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort</brief_title>
  <official_title>ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Symetis SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      First clinical experience on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation&#xD;
      in Patients with Severe Aortic Stenosis to collect human data pertaining to the safety and&#xD;
      performance of the device from three different cohorts&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, multicenter, &quot;CE-approval cohort&quot; analysis with the Symetis ACURATE TF™&#xD;
      Transfemoral Aortic Bioprosthesis for minimal invasive implantation via transfemoral access&#xD;
      to treat patients with severe aortic stenosis where conventional aortic valve replacement&#xD;
      (AVR) via open heart surgery is considered to be associated with high risk, to evaluate the&#xD;
      feasibility and performance of the implantation at 30-Days and at 1-Year Follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">July 2013</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 all-cause mortality</measure>
    <time_frame>30-Day Follow-up</time_frame>
    <description>Rate of all-cause mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of MACCE (major cardiac and cerebrovascular event) related to the ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System.</measure>
    <time_frame>30-Days and 12 Months Follow-up</time_frame>
    <description>Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months follow-up related to ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System and defined as all cause death, myocardial infarction, re-intervention and stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NYHA class over time</measure>
    <time_frame>30-Day and 12-Month</time_frame>
    <description>Functional improvement from baseline NYHA classification at 30 day and at 12 month follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural success during device implantation</measure>
    <time_frame>intraoperative</time_frame>
    <description>Procedural Success defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography and without intra-procedural mortality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>30-Day and 12-Month Follow-up</time_frame>
    <description>Device success is defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography.&#xD;
The following data points will be analyzed for adequate functioning of the study device:&#xD;
Effective orifice area and index (EOA)&#xD;
Peak jet velocity&#xD;
Transvalvular aortic gradient (mean)&#xD;
Paravalvular and intravalvular (central) leak&#xD;
Aortic Insufficiency&#xD;
Valve function and morphology</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Symptomatic Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>Symetis ACURATE TF™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient implanted with ACURATE TF™Bioprosthesis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ACURATE TF™</intervention_name>
    <description>ACURATE TF™Transfemoral Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement .</description>
    <arm_group_label>Symetis ACURATE TF™</arm_group_label>
    <other_name>ACURATE TF™Transfemoral Aortic Bioprosthesis and Delivery System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients 75 years of age and older&#xD;
&#xD;
          2. Logistic EuroSCORE ≥ 20%&#xD;
&#xD;
          3. Severe aortic stenosis characterized by mean aortic gradient &gt; 40 mmHg or peak jet&#xD;
             velocity &gt; 4.0 m/s or aortic valve area of &lt; 1.0 cm2&#xD;
&#xD;
          4. New York Heart Association (NYHA) Functional Class &gt; II&#xD;
&#xD;
          5. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by Trans-esophageal Echocardiography&#xD;
             (TEE)&#xD;
&#xD;
          6. Patient not a surgical candidate due to significant co-morbid conditions unrelated to&#xD;
             aortic stenosis&#xD;
&#xD;
          7. Patient willing to participate in the study and provide signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unicuspid or bicuspid aortic valve&#xD;
&#xD;
          2. Extreme eccentricity of calcification&#xD;
&#xD;
          3. Severe mitral regurgitation ( &gt;2+)&#xD;
&#xD;
          4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring&#xD;
&#xD;
          5. Aortic or peripheral anatomy NOT appropriate for transfemoral implant&#xD;
&#xD;
          6. Thoracic (TAA) or abdominal (AAA) aortic aneurysm&#xD;
&#xD;
          7. Presence of endovascular stent graft for treatment of TAA or AAA&#xD;
&#xD;
          8. TEE is contraindicated&#xD;
&#xD;
          9. Left Ventricular Ejection Fraction (LVEF) &lt; 30% by echocardiography (ECHO)&#xD;
&#xD;
         10. ECHO evidence of intracardiac mass, thrombus, or vegetation&#xD;
&#xD;
         11. Acute Myocardial Infarction (AMI) within 1 month prior to implant procedure&#xD;
&#xD;
         12. Percutaneous Coronary Intervention (PCI), except for balloon valvuloplasty (BAV)&#xD;
             within 1 month prior to implant procedure&#xD;
&#xD;
         13. Previous Transien Ischemic Attack (TIA) or stroke within 3 months prior to implant&#xD;
             procedure&#xD;
&#xD;
         14. Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant&#xD;
             procedure&#xD;
&#xD;
         15. Any scheduled surgical or percutaneous procedure to be performed prior to 30 day visit&#xD;
&#xD;
         16. History of bleeding diathesis or coagulopathy or refusal of blood transfusions&#xD;
&#xD;
         17. Systolic pressure &lt;80 mmHg, cardiogenic shock, need for inotropic support or&#xD;
             Intra-Aortic Balloon Pump (IABP)&#xD;
&#xD;
         18. Primary hypertrophic obstructive cardiomyopathy (HOCM)&#xD;
&#xD;
         19. Active infection, endocarditis or pyrexia&#xD;
&#xD;
         20. Hepatic failure&#xD;
&#xD;
         21. Chronic renal dysfunction with serum creatinine &gt; 2.5 mg/dL or renal dialysis&#xD;
&#xD;
         22. Refusal of surgery&#xD;
&#xD;
         23. Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen&#xD;
&#xD;
         24. Neurological disease severely affecting ambulation or daily functioning, or dementia&#xD;
&#xD;
         25. Life expectancy &lt; 12 months due to non-cardiac co-morbid conditions&#xD;
&#xD;
         26. Known hypersensitivity/contraindication to study medication, contrast media, or&#xD;
             nitinol&#xD;
&#xD;
         27. Currently participating in an investigational drug or another device study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Instituto Dante Pazzanese de Cardiologia</name>
      <address>
        <city>Sao Paulo</city>
        <zip>CEP 04012-909</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kerckhoff Klinik GmbH</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäres Herzzentrum Hamburg</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Universitätsklinikum Köln</name>
      <address>
        <city>Köln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Germany</country>
    <country>Japan</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>November 22, 2018</last_update_submitted>
  <last_update_submitted_qc>November 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Severe Symptomatic Aortic Valve Stenosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <!-- 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/NCT03003650
org study id: TF89
nct id: NCT03003650
lead sponsor: 
has dmc: Yes
First clinical experience on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation
      in Patients with Severe Aortic Stenosis to collect human data pertaining to the safety and
      performance of the device from three different cohorts
A prospective, multicenter, "CE-approval cohort" analysis with the Symetis ACURATE TF™
      Transfemoral Aortic Bioprosthesis for minimal invasive implantation via transfemoral access
      to treat patients with severe aortic stenosis where conventional aortic valve replacement
      (AVR) via open heart surgery is considered to be associated with high risk, to evaluate the
      feasibility and performance of the implantation at 30-Days and at 1-Year Follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom from all-cause mortality
time frame: 30-Day Follow-up
description: Rate of all-cause mortality
measure: Rate of MACCE (major cardiac and cerebrovascular event) related to the ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System.
time frame: 30-Days and 12 Months Follow-up
description: Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months follow-up related to ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System and defined as all cause death, myocardial infarction, re-intervention and stroke.
measure: Change in NYHA class over time
time frame: 30-Day and 12-Month
description: Functional improvement from baseline NYHA classification at 30 day and at 12 month follow-up.
measure: Procedural success during device implantation
time frame: intraoperative
description: Procedural Success defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography and without intra-procedural mortality.
measure: Device success
time frame: 30-Day and 12-Month Follow-up
description: Device success is defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography.
The following data points will be analyzed for adequate functioning of the study device:
Effective orifice area and index (EOA)
Peak jet velocity
Transvalvular aortic gradient (mean)
Paravalvular and intravalvular (central) leak
Aortic Insufficiency
Valve function and morphology
arm group label: Symetis ACURATE TF™
arm group type: Experimental
description: Patient implanted with ACURATE TF™Bioprosthesis.
intervention type: Device
intervention name: ACURATE TF™
description: ACURATE TF™Transfemoral Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement .
arm group label: Symetis ACURATE TF™
other name: ACURATE TF™Transfemoral Aortic Bioprosthesis and Delivery System
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
country: Germany
country: Japan
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic