<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/NCT02986737</url>
  </required_header>
  <id_info>
    <org_study_id>2014-02</org_study_id>
    <nct_id>NCT02986737</nct_id>
  </id_info>
  <brief_title>ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis</brief_title>
  <acronym>TALP-FIM</acronym>
  <official_title>ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System 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>
      Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP&#xD;
      Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety&#xD;
      and performance of the study device&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single arm, prospective, multicenter non randomised and open trial of the treatment&#xD;
      of patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via&#xD;
      open heart surgery is considered to be high risk. All patients will be followed up to 5 years&#xD;
      after the intervention.&#xD;
&#xD;
      The primary objective is to evaluate the safety and performance of the study device in&#xD;
      patients presenting with severe aortic stenosis considered to be high risk for surgery&#xD;
      Secondary objective is to evaluate adverse events and study device performance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 8, 2014</start_date>
  <completion_date type="Actual">October 2019</completion_date>
  <primary_completion_date type="Actual">March 3, 2015</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>
    <intervention_model_description>Medical device trial</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>30 days</time_frame>
    <description>incidence of all cause mortality at 30 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean aortic gradient after device implantation</measure>
    <time_frame>7 days or Discharge</time_frame>
    <description>mean aortic gradient evaluated by echocardiography and by the site at 7days or discharge per standard post-implantation follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>rate of clinical endpoints VARC II</measure>
    <time_frame>30 days and month 12</time_frame>
    <description>rate of clinical endpoints VARC II at 30 days and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>procedural success</measure>
    <time_frame>procedure</time_frame>
    <description>procedural success defined as ACURATE neo™ at intended location</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>device success assessed according to composite VARC 2 criteria</measure>
    <time_frame>7 days, 30 days, 12 months</time_frame>
    <description>Device success defined as:&#xD;
ACURATE neo™ implanted in intended location&#xD;
No impingement of the mitral valve&#xD;
Normal coronary blood flow&#xD;
Insufficiency &lt; Grade 3&#xD;
Mean aortic gradient &lt; 20mmHg&#xD;
EOA ≥ 1.0 cm2 No further re-intervention performed on the ACURATE neo™ implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional improvement from Baseline as per NYHA Functional Classification</measure>
    <time_frame>30 days and 12 months follow up</time_frame>
    <description>functional improvement from baseline as per NYHA functional classification at 30 days and 12 months follow up</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>ACURATE neo™ and ACURATE TA™ LP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients implanted with ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ACURATE neo™ and ACURATE TA™ LP</intervention_name>
    <description>ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System on patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open-heart surgery is considered to be high risk</description>
    <arm_group_label>ACURATE neo™ and ACURATE TA™ LP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient 75 years of age and older&#xD;
&#xD;
          2. Severe aortic stenosis defined as:&#xD;
&#xD;
             Mean aortic gradient &gt; 40mmHg or o Peak jet velocity &gt; 4.0m/sor Aortic valve area of &lt;&#xD;
             1.0cm2&#xD;
&#xD;
          3. High risk candidate for conventional AVR defined as:&#xD;
&#xD;
             STS score ≥ 10 or Multidisciplinary heart team (cardiologist and cardiac surgeon)&#xD;
             consensus that patient is not a surgical candidate for conventional AVR due to&#xD;
             significant co- morbid conditions unrelated to aortic stenosis&#xD;
&#xD;
          4. NYHA Functional Class &gt; II&#xD;
&#xD;
          5. Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the&#xD;
             transapical approach is the most suitable TAVI access route&#xD;
&#xD;
          6. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT or TEE&#xD;
&#xD;
          7. Patient willing to participate in the study and provides signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Congenital unicuspid or bicuspid aortic valve&#xD;
&#xD;
          2. Extreme eccentricity of calcification&#xD;
&#xD;
          3. Severe mitral regurgitation (&gt; Grade 2)&#xD;
&#xD;
          4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring&#xD;
&#xD;
          5. LV apex is not accessible via transapical access due to severe chest deformity&#xD;
&#xD;
          6. Previous surgery of the LV using a patch, such as the Dor procedure&#xD;
&#xD;
          7. Presence of apical LV thrombus&#xD;
&#xD;
          8. Calcified pericardium&#xD;
&#xD;
          9. Septal hypertrophy unacceptable for transapical procedure&#xD;
&#xD;
         10. Transesophageal echocardiogram (TEE) is contraindicated&#xD;
&#xD;
         11. ECHO evidence of intracardiac mass, thrombus, or vegetation&#xD;
&#xD;
         12. LVEF &lt; 30% by ECHO&#xD;
&#xD;
         13. Emergency procedure pre-implant including CAD requiring revascularization&#xD;
&#xD;
         14. Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month&#xD;
             prior to implant procedure&#xD;
&#xD;
         15. Acute myocardial infarction within 1 month prior to implant procedure&#xD;
&#xD;
         16. Previous TIA or stroke within 3 months prior to implant procedure&#xD;
&#xD;
         17. Active gastrointestinal (GI) bleeding within 3 months prior to implant procedure&#xD;
&#xD;
         18. Scheduled surgical or percutaneous procedure to be performed prior to 30 day visit&#xD;
&#xD;
         19. History of bleeding diathesis or coagulopathy or refusal of blood transfusions&#xD;
&#xD;
         20. Systolic pressure &lt;80mmHg, cardiogenic shock, need for inotropic support or IABP&#xD;
&#xD;
         21. Primary hypertrophic obstructive cardiomyopathy (HOCM)&#xD;
&#xD;
         22. Active infection, endocarditis or pyrexia&#xD;
&#xD;
         23. Hepatic failure (&gt; Child B)&#xD;
&#xD;
         24. Chronic renal dysfunction with serum creatinine &gt; 2.5 mg/dL or renal dialysis&#xD;
&#xD;
         25. Refusal of surgery&#xD;
&#xD;
         26. Severe COPD requiring home oxygen&#xD;
&#xD;
         27. Neurological disease severely affecting ambulation, daily functioning, or dementia&#xD;
&#xD;
         28. Life expectancy &lt; 12 months due to non-cardiac co-morbid conditions&#xD;
&#xD;
         29. Contraindication to study medication, contrast media, or allergy to nitinol&#xD;
&#xD;
         30. 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>Mirko Doss, Prof.Dr.Med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abteilung Herzchirurgie Kerckhoff-Klinik</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kerckhoff-Klinik</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Herz-und Gefäßchirurgie</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 6, 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>April 7, 2020</last_update_submitted>
  <last_update_submitted_qc>April 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TAVI</keyword>
  <keyword>Aortic Stenosis</keyword>
  <keyword>Transcatether Aortic Valve Implantation</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>
  <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/NCT02986737
org study id: 2014-02
nct id: NCT02986737
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP
      Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety
      and performance of the study device
This is a single arm, prospective, multicenter non randomised and open trial of the treatment
      of patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via
      open heart surgery is considered to be high risk. All patients will be followed up to 5 years
      after the intervention.

      The primary objective is to evaluate the safety and performance of the study device in
      patients presenting with severe aortic stenosis considered to be high risk for surgery
      Secondary objective is to evaluate adverse events and study device performance.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Medical device trial
primary purpose: Device Feasibility
masking: None (Open Label)
measure: All cause mortality
time frame: 30 days
description: incidence of all cause mortality at 30 days
measure: Mean aortic gradient after device implantation
time frame: 7 days or Discharge
description: mean aortic gradient evaluated by echocardiography and by the site at 7days or discharge per standard post-implantation follow-up
measure: rate of clinical endpoints VARC II
time frame: 30 days and month 12
description: rate of clinical endpoints VARC II at 30 days and 12 months
measure: procedural success
time frame: procedure
description: procedural success defined as ACURATE neo™ at intended location
measure: device success assessed according to composite VARC 2 criteria
time frame: 7 days, 30 days, 12 months
description: Device success defined as:
ACURATE neo™ implanted in intended location
No impingement of the mitral valve
Normal coronary blood flow
Insufficiency < Grade 3
Mean aortic gradient < 20mmHg
EOA ≥ 1.0 cm2 No further re-intervention performed on the ACURATE neo™ implant
measure: functional improvement from Baseline as per NYHA Functional Classification
time frame: 30 days and 12 months follow up
description: functional improvement from baseline as per NYHA functional classification at 30 days and 12 months follow up
arm group label: ACURATE neo™ and ACURATE TA™ LP
arm group type: Experimental
description: Patients implanted with ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System
intervention type: Device
intervention name: ACURATE neo™ and ACURATE TA™ LP
description: ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System on patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open-heart surgery is considered to be high risk
arm group label: ACURATE neo™ and ACURATE TA™ LP
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Mirko Doss, Prof.Dr.Med
role: Principal Investigator
affiliation: Abteilung Herzchirurgie Kerckhoff-Klinik
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic
sharing ipd: No