<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/NCT03752996</url>
  </required_header>
  <id_info>
    <org_study_id>2011-03</org_study_id>
    <nct_id>NCT03752996</nct_id>
  </id_info>
  <brief_title>ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)</brief_title>
  <acronym>2011-03</acronym>
  <official_title>ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in&#xD;
      Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the&#xD;
      safety and performance of the device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A single arm, prospective, multicenter, non-randomized, open trial, up to 5 Years follow-up&#xD;
      with the Symetis ACURATE TF™ Transfemoral Aortic Bioprosthesis for minimal invasive&#xD;
      implantation via transfemoral access to treat patients with severe aortic stenosis where&#xD;
      conventional aortic valve replacement (AVR) via open heart surgery is considered to be&#xD;
      associated with high risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 9, 2012</start_date>
  <completion_date type="Actual">March 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</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-Days</time_frame>
    <description>Rate of all-cause mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of MACCE (major cardiac and cerebrovascular event)</measure>
    <time_frame>30-Days and 12-Months</time_frame>
    <description>Rate of major cardiac and cerebrovascular event (MACCE) defined as cardiovascular death, myocardial infarction and stroke</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Aortic Stenosis Symptomatic</condition>
  <arm_group>
    <arm_group_label>ACURATE TF™ Aortic Valve System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACURATE TF™ Aortic Valve System is intended for subjects with severe symptomatic Aortic Stenosis and considered high risk for surgical conventional Aortic Valve Replacement .</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ACURATE TF™ Aortic Valve System</intervention_name>
    <description>Transcatheter Aortic Valve Implantation</description>
    <arm_group_label>ACURATE TF™ Aortic Valve System</arm_group_label>
  </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 &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 measured by 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. Trans-esophageal echocardiogram (TEE) is contraindicated&#xD;
&#xD;
          9. Left Ventricle 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 Transient 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 Obstruction 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>
  <overall_official>
    <last_name>Won Keun Kim, Dr. Med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kerckhoff Klinik Bad Nauheim, Germany</affiliation>
  </overall_official>
  <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_countries>
    <country>Brazil</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 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 Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</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/NCT03752996
org study id: 2011-03
nct id: NCT03752996
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in
      Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the
      safety and performance of the device.
A single arm, prospective, multicenter, non-randomized, open trial, up to 5 Years follow-up
      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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom from all-cause mortality
time frame: 30-Days
description: Rate of all-cause mortality
measure: Rate of MACCE (major cardiac and cerebrovascular event)
time frame: 30-Days and 12-Months
description: Rate of major cardiac and cerebrovascular event (MACCE) defined as cardiovascular death, myocardial infarction and stroke
arm group label: ACURATE TF™ Aortic Valve System
arm group type: Experimental
description: ACURATE TF™ Aortic Valve System is intended for subjects with severe symptomatic Aortic Stenosis and considered high risk for surgical conventional Aortic Valve Replacement .
intervention type: Device
intervention name: ACURATE TF™ Aortic Valve System
description: Transcatheter Aortic Valve Implantation
arm group label: ACURATE TF™ Aortic Valve System
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Won Keun Kim, Dr. Med.
role: Principal Investigator
affiliation: Kerckhoff Klinik Bad Nauheim, Germany
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
country: Germany
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic
sharing ipd: No