xml: <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/NCT06008080</url>
    </required_header>
    <id_info>
      <org_study_id>ABT-CIP-10476</org_study_id>
      <nct_id>NCT06008080</nct_id>
    </id_info>
    <brief_title>Post-Market Clinical Follow Up Study With Navitor Valve</brief_title>
    <acronym>VISTA</acronym>
    <official_title>VISTA Study (Navitor Post-Market Clinical Follow Up Study)</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Evaluation of the safety and performance of the Navitor TAVI System in a Global Study&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The VISTA Study will evaluate the safety, performance, and long-term durability of the&#xD;
        Navitor valve in a real-world setting.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2030</completion_date>
    <primary_completion_date type="Anticipated">January 2026</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>All-cause mortality at 30 days post-TAVI procedure</measure>
      <time_frame>30 days post index procedure</time_frame>
      <description>Death from all causes at 30 days post-TAVI procedure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Moderate or greater paravalvular leak at 30 days post-TAVI procedure</measure>
      <time_frame>30 days post index procedure</time_frame>
      <description>Assessment of paravalvular leak at 30 days post-TAVI procedure</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Aortic Stenosis</condition>
    <arm_group>
      <arm_group_label>Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System</arm_group_label>
      <description>The Navitor valve is available in four valve sizes to cover annulus diameters from 19 mm to 27 mm. The FlexNav delivery system is available in two sizes, small and large. The Navitor loading system is an accessory used to compress and load the Navitor valve onto the FlexNav delivery system and is available in two sizes, small and large.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System</intervention_name>
      <description>Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System</description>
      <arm_group_label>Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study will enroll subjects of all genders from the population of patients qualifying&#xD;
          for TAVI.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The patient is scheduled to undergo a Navitor TAVI procedure.&#xD;
  &#xD;
            -  The patient has been informed of the nature of the study, agrees to its provisions,&#xD;
               and has provided written informed consent as approved by the IRB (Investigational&#xD;
               Review Board)/EC (Ethics Committee) of the respective clinical site.&#xD;
  &#xD;
            -  The patient and the treating physician agree that the subject will return for all&#xD;
               required post procedure follow up visits.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Life expectancy &lt; 12 months from the time of informed consent due to non-cardiac&#xD;
               co-morbid conditions.&#xD;
  &#xD;
            -  In the judgment of the Investigator, patient presents with a medical, social, or&#xD;
               psychological condition that could limit the ability or willingness to participate in&#xD;
               the study, comply with study required testing and/or follow-up visits or that could&#xD;
               impact scientific integrity of the study.&#xD;
  &#xD;
            -  Known contraindication for computed tomography (CT) or sensitivity to contrast media,&#xD;
               which cannot be adequately premedicated.&#xD;
  &#xD;
            -  Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel&#xD;
               and titanium), which cannot be adequately premedicated.&#xD;
  &#xD;
            -  Currently participating in an investigational drug or device study that may confound&#xD;
               the results of this study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alper Öner, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universitätsmedizin Rostock, Germany</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nicolas Dumonteil, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Clinique Pasteur Toulouse, France</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Vinny Podichetty</last_name>
      <role>Study Director</role>
      <affiliation>Abbott</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bart Janssens</last_name>
      <phone>+32471723201</phone>
      <email>bart.janssens@abbott.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nick Bates</last_name>
      <phone>+16519686180</phone>
      <email>nick.bates@abbott.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>NAVITOR</keyword>
    <keyword>Transcatheter aortic valve implantation (TAVI)</keyword>
    <keyword>Aortic Stenosis</keyword>
    <keyword>Cardiovascular Disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aortic Valve Stenosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008080
  org study id: ABT-CIP-10476
  nct id: NCT06008080
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: Yes
  Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
  The VISTA Study will evaluate the safety, performance, and long-term durability of the
        Navitor valve in a real-world setting.
  observational model: Cohort
  time perspective: Prospective
  measure: All-cause mortality at 30 days post-TAVI procedure
  time frame: 30 days post index procedure
  description: Death from all causes at 30 days post-TAVI procedure
  measure: Moderate or greater paravalvular leak at 30 days post-TAVI procedure
  time frame: 30 days post index procedure
  description: Assessment of paravalvular leak at 30 days post-TAVI procedure
  arm group label: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
  description: The Navitor valve is available in four valve sizes to cover annulus diameters from 19 mm to 27 mm. The FlexNav delivery system is available in two sizes, small and large. The Navitor loading system is an accessory used to compress and load the Navitor valve onto the FlexNav delivery system and is available in two sizes, small and large.
  intervention type: Device
  intervention name: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
  description: Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System
  arm group label: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Alper Öner, MD
  role: Principal Investigator
  affiliation: Universitätsmedizin Rostock, Germany
  last name: Nicolas Dumonteil, MD
  role: Principal Investigator
  affiliation: Clinique Pasteur Toulouse, France
  last name: Vinny Podichetty
  role: Study Director
  affiliation: Abbott
  last name: Bart Janssens
  phone: +32471723201
  email: bart.janssens@abbott.com
  last name: Nick Bates
  phone: +16519686180
  email: nick.bates@abbott.com
  responsible party type: Sponsor
  mesh term: Aortic Valve Stenosis
  sharing ipd: No