<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/NCT03825406</url>
  </required_header>
  <id_info>
    <org_study_id>#: 201802928</org_study_id>
    <nct_id>NCT03825406</nct_id>
  </id_info>
  <brief_title>Prevalence of Wildtype Amyloid After TAVR</brief_title>
  <official_title>Prevalence of Wildtype Amyloid Among TAVR Patients With Impaired Hemodynamics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North Florida Foundation for Research and Education</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>North Florida Foundation for Research and Education</source>
  <oversight_info>
    <has_dmc>No</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>
      Those with abnormal vital signs after TAVR need to be willing to obtain a bone scan to&#xD;
      evaluate for wildtype amyloidosis. Positive bone scan findings will require evaluation for&#xD;
      primary amyloidosis with blood and urine monoclonal immunoglobulin testing. Primary&#xD;
      amyloidosis is a different type of disease which requires different treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research is interested in determining how common wildtype amyloidosis is after&#xD;
      transcatheter aortic valve replacement (TAVR). Amyloidosis is a condition characterized by&#xD;
      abnormal protein which can accumulate and impair various organs, including the heart.&#xD;
      Research suggests that amyloidosis might be common among TAVR patients, but it is a condition&#xD;
      that is not routinely evaluated for. We suspect that wildtype amyloidosis may be especially&#xD;
      common among patients with abnormal vital signs after their TAVR procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Dr. Bavry is recruiting the same patients for a NIH trial.&#xD;
  </why_stopped>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Actual">March 20, 2019</completion_date>
  <primary_completion_date type="Actual">March 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants who die or have poor quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)</measure>
    <time_frame>1 to 2 years post TAVR</time_frame>
    <description>Measurement tool is the Kansas City Cardiomyopathy Questionnaire (KCCQ)</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Amyloidosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This research is interested in determining how prevalent wildtype amyloidosis is after&#xD;
        transcatheter aortic valve replacement (TAVR) patients with impaired hemodynamics.&#xD;
        Amyloidosis is a condition characterized by abnormal protein which can accumulate and&#xD;
        impair various organs, including the heart. Research suggests that amyloidosis might be&#xD;
        common among TAVR patients, but this condition is not routinely evaluated for. We suspect&#xD;
        that wildtype amyloidosis may be especially common among patients with abnormal vital signs&#xD;
        after their TAVR procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Patients that underwent a TAVR procedure at the Malcolm Randall VA Medical Center.&#xD;
&#xD;
          -  Implant of current generation TAVR (i.e. Sapien S3, Evolut R, or Evolut Pro).&#xD;
&#xD;
          -  Willingness to obtain bone scintigraphy if evidence of impaired hemodynamics after&#xD;
             valve deployment.&#xD;
&#xD;
          -  Willingness to have blood drawn&#xD;
&#xD;
          -  Willingness to complete SF12 quality of life KCCQ&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        --Patient that do not qualify for a TAVR procedure as normal clinical care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony Bavry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ACC AHA</affiliation>
  </overall_official>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</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>Amyloidosis</mesh_term>
  </condition_browse>
  <study_docs>
    <study_doc>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://va.gov</doc_url>
      <doc_comment>Type Study Protocol To request an electronic copy send email to Anthony.bavry@va.gov or debra.robertson1@va.gov</doc_comment>
    </study_doc>
    <study_doc>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>http://va.gov</doc_url>
      <doc_comment>De-identified data set for primary and secondary outcomes measures To request an electronic copy send email to Anthony.bavry@va.gov or Debra.robertson1@va.gov</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03825406
org study id: #: 201802928
nct id: NCT03825406
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Those with abnormal vital signs after TAVR need to be willing to obtain a bone scan to
      evaluate for wildtype amyloidosis. Positive bone scan findings will require evaluation for
      primary amyloidosis with blood and urine monoclonal immunoglobulin testing. Primary
      amyloidosis is a different type of disease which requires different treatment.
This research is interested in determining how common wildtype amyloidosis is after
      transcatheter aortic valve replacement (TAVR). Amyloidosis is a condition characterized by
      abnormal protein which can accumulate and impair various organs, including the heart.
      Research suggests that amyloidosis might be common among TAVR patients, but it is a condition
      that is not routinely evaluated for. We suspect that wildtype amyloidosis may be especially
      common among patients with abnormal vital signs after their TAVR procedure.
observational model: Case-Only
time perspective: Prospective
measure: Number of participants who die or have poor quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
time frame: 1 to 2 years post TAVR
description: Measurement tool is the Kansas City Cardiomyopathy Questionnaire (KCCQ)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 100 Years
healthy volunteers: No
last name: Anthony Bavry, MD
role: Principal Investigator
affiliation: ACC AHA
responsible party type: Sponsor
mesh term: Amyloidosis
study doc: 
study doc: 