<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/NCT02971020</url>
  </required_header>
  <id_info>
    <org_study_id>4588-A</org_study_id>
    <nct_id>NCT02971020</nct_id>
  </id_info>
  <brief_title>Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement</brief_title>
  <acronym>CAVIAR</acronym>
  <official_title>Proposal for Collection of Patient Data to Aid in Design of an Observational Study (i.e. Preparatory to Research) Evaluating Risk of Cognitive Impairment After Surgical and Transcatheter Valve Replacement.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minnesota Veterans Medical Research and Education Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Minneapolis Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Center for Veterans Research and Education</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are conducting a pilot study to compare cognitive outcomes among Veterans&#xD;
      with severe aortic valve stenosis who are scheduled to undergo either aortic valve&#xD;
      replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are conducting a pilot study to compare cognitive outcomes in up to 60&#xD;
      Veterans with severe aortic valve stenosis who are scheduled to undergo either transcatheter&#xD;
      aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) at the&#xD;
      Minneapolis VA Health Care System. Participants will be administered a short battery of&#xD;
      cognitive tests before and three months after TAVR or SAVR over/up to a two year study&#xD;
      period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">March 21, 2018</completion_date>
  <primary_completion_date type="Actual">November 12, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Montreal Cognitive Assessment</measure>
    <time_frame>Three Months</time_frame>
    <description>Estimate the means and standard deviations of changes in selected cognitive measures between baseline (pre-TAVR or pre-SAVR) and 3 months post-TAVR or post-SAVR, identify baseline correlates of those changes, and characterize baseline cognitive function and cognitive history of patients who undergo TAVR or SAVR.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trail Making</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Cardiovascular Disease</condition>
  <condition>Aortic Valve Stenosis</condition>
  <condition>Cognitive Assessments</condition>
  <condition>Valve Surgery</condition>
  <condition>Transcatheter Valve Replacement</condition>
  <condition>Surgical Valve Replacement</condition>
  <arm_group>
    <arm_group_label>Surgical Aortic Valve Replacement</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transcatheter Aortic Valve Replacement</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational/Cognitive Assessment</intervention_name>
    <description>Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).</description>
    <arm_group_label>Surgical Aortic Valve Replacement</arm_group_label>
    <arm_group_label>Transcatheter Aortic Valve Replacement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe aortic stenosis (AVA: 1 cm2 and/or mean gradient =or &gt; 40 mmHg and/or peak&#xD;
             velocity &gt; 4 m/s)&#xD;
&#xD;
          -  Scheduled to undergo either surgical or transcatheter aortic valve replacement at the&#xD;
             Minneapolis VA Health Care System&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive impairment at baseline (i.e. unable to understand or follow-up study&#xD;
             procedures)&#xD;
&#xD;
          -  Unable or unwilling to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>104 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Santiago Garcia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Minneapolis Veterans Affairs Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Howard Fink, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Minneapolis Veterans Affairs Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Minneapolis VA Health Care System</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 12, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>March 22, 2018</last_update_submitted>
  <last_update_submitted_qc>March 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Minnesota Veterans Medical Research and Education Foundation</investigator_affiliation>
    <investigator_full_name>Santiago Garcia</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT02971020
org study id: 4588-A
nct id: NCT02971020
lead sponsor: 
collaborator: 
has dmc: Yes
The investigators are conducting a pilot study to compare cognitive outcomes among Veterans
      with severe aortic valve stenosis who are scheduled to undergo either aortic valve
      replacement.
The investigators are conducting a pilot study to compare cognitive outcomes in up to 60
      Veterans with severe aortic valve stenosis who are scheduled to undergo either transcatheter
      aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) at the
      Minneapolis VA Health Care System. Participants will be administered a short battery of
      cognitive tests before and three months after TAVR or SAVR over/up to a two year study
      period.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Montreal Cognitive Assessment
time frame: Three Months
description: Estimate the means and standard deviations of changes in selected cognitive measures between baseline (pre-TAVR or pre-SAVR) and 3 months post-TAVR or post-SAVR, identify baseline correlates of those changes, and characterize baseline cognitive function and cognitive history of patients who undergo TAVR or SAVR.
measure: Trail Making
time frame: 3 months
arm group label: Surgical Aortic Valve Replacement
arm group type: Other
description: Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
arm group label: Transcatheter Aortic Valve Replacement
arm group type: Other
description: Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
intervention type: Other
intervention name: Observational/Cognitive Assessment
description: Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
arm group label: Surgical Aortic Valve Replacement
arm group label: Transcatheter Aortic Valve Replacement
criteria: 
gender: All
minimum age: N/A
maximum age: 104 Years
healthy volunteers: No
last name: Santiago Garcia, MD
role: Principal Investigator
affiliation: Minneapolis Veterans Affairs Medical Center
last name: Howard Fink, MD
role: Principal Investigator
affiliation: Minneapolis Veterans Affairs Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Minnesota Veterans Medical Research and Education Foundation
investigator full name: Santiago Garcia
investigator title: MD
mesh term: Cardiovascular Diseases
mesh term: Aortic Valve Stenosis
mesh term: Cognitive Dysfunction
sharing ipd: No