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/NCT06015997</url>
    </required_header>
    <id_info>
      <org_study_id>ANAC.JO.2023.ATTR.TAVR.ME</org_study_id>
      <nct_id>NCT06015997</nct_id>
    </id_info>
    <brief_title>Prevalence of ATTR Cardiac Amyloidosis in Patients Undergoing TAVR</brief_title>
    <official_title>The Prevalence of ATTR Cardiac Amyloidosis in Elderly Middle Eastern Patients Undergoing Transarterial Aortic Valve Replacement</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jordan Collaborating Cardiology Group</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jordan Collaborating Cardiology Group</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>
        ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe&#xD;
        calcific aortic stenosis (AS). The reasons for this association are not fully known. It is&#xD;
        hypothesized that an amyloidotic infiltration of the aortic valve acts as a trigger for the&#xD;
        development of endothelial damage and subsequent calcification. Elderly patients undergoing&#xD;
        TAVI will be evaluated for the presence of ATTR-CA in Jordan.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe&#xD;
        calcific aortic stenosis (AS). The reasons for this association are not fully known. Two&#xD;
        hypotheses may explain this association&#xD;
  &#xD;
          1. Amyloidotic infiltration of the aortic valve acts as a trigger for the development of&#xD;
             endothelial damage and subsequent calcification.&#xD;
  &#xD;
          2. The increased myocardial strain induced by AS may locally favor the process of&#xD;
             amyloidogenesis and tissue infiltration.&#xD;
  &#xD;
        Transarterial AV replacement (TAVI) is the treatment of choice for elderly patients with&#xD;
        severe calcific AS. Studies have shown a prevalence of about 10% of ATTR cardiac amyloidosis&#xD;
        in patients undergoing TAVI. The diagnosis is based on a positive nuclear scan (PYP, DPD or&#xD;
        HMDP) and ruling out AL amyloidosis in patients with positive scans. While studies have shown&#xD;
        no impact of ATTR on prognosis in TAVI patients, there is evidence of poorer quality of life,&#xD;
        increased in-hospital acute ischemic stroke, increased cardiac and heart failure&#xD;
        hospitalizations, increased conduction abnormalities, compared to patients without ATTR&#xD;
        undergoing TAVI.&#xD;
  &#xD;
        The prevalence of ATTR in TAVI patients in Jordan and Middle Eastern populations has not been&#xD;
        previously evaluated. The purpose of this study is to evaluate the prevalence of ATTR cardiac&#xD;
        amyloidosis in elderly Middle Eastern patients undergoing TAVI and to document the clinical&#xD;
        characteristics, procedural outcomes and 1 year follow up of such patients compared to&#xD;
        patients without ATTR.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</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>Prevalence of ATTR CA in TAVR patients</measure>
      <time_frame>On admission ( from time of admission to time of discharge from the hospital) and within 10 days.</time_frame>
      <description>Consecutive elderly (≥65 years) patients who are undergoing TAVI will be included.&#xD;
  Patients will be invited to undergo a pyruvate PO4 (PYP) scan. Patients with positive scans will undergo further testing to rule out AL amyloidosis (Free light chain assay, SIFEP, UIFEP). Data collection will include all pertinent clinical characteristics, peri- procedural details.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cardiovascular event at One year follow up</measure>
      <time_frame>One year after enrollment: up to 30 days after the passage of 365 days after the TAVR procedure</time_frame>
      <description>Events at one year defined as the occurrence of all-cause death, and hospital admission for heart failure or aortic valve reintervention.</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>ATTR Amyloidosis Wild Type</condition>
    <condition>Severe Aortic Stenosis</condition>
    <condition>Aortic Valve Stenosis</condition>
    <condition>Middle East Studies</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Consecutive elderly patients, 65 years of age or older, with a diagnosis of severe aortic&#xD;
          stenosis who undergo TAVR will be evaluated for the possible diagnosis of an underlying&#xD;
          ATTR cardiac amyloidosis.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥65 years&#xD;
  &#xD;
            -  Severe aortic stenosis&#xD;
  &#xD;
            -  Patient underwent TAVR procedure&#xD;
  &#xD;
            -  Positive pyruvate PO4 scan&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of AL amyloidosis base on free light chain assay, serum and urine immune&#xD;
               electrophoresis.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ramzi Tabbalat, MD, FACC</last_name>
      <phone>00962795535522</phone>
      <email>ramzi_md@yahoo.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ATTR cardiac amyloidosis</keyword>
    <keyword>Severe aortic stenosis</keyword>
    <keyword>Transarterial aortic valve replacement</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aortic Valve Stenosis</mesh_term>
      <mesh_term>Amyloidosis</mesh_term>
      <mesh_term>Constriction, Pathologic</mesh_term>
    </condition_browse>
    <!-- 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/NCT06015997
  org study id: ANAC.JO.2023.ATTR.TAVR.ME
  nct id: NCT06015997
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe
        calcific aortic stenosis (AS). The reasons for this association are not fully known. It is
        hypothesized that an amyloidotic infiltration of the aortic valve acts as a trigger for the
        development of endothelial damage and subsequent calcification. Elderly patients undergoing
        TAVI will be evaluated for the presence of ATTR-CA in Jordan.
  ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe
        calcific aortic stenosis (AS). The reasons for this association are not fully known. Two
        hypotheses may explain this association
  
          1. Amyloidotic infiltration of the aortic valve acts as a trigger for the development of
             endothelial damage and subsequent calcification.
  
          2. The increased myocardial strain induced by AS may locally favor the process of
             amyloidogenesis and tissue infiltration.
  
        Transarterial AV replacement (TAVI) is the treatment of choice for elderly patients with
        severe calcific AS. Studies have shown a prevalence of about 10% of ATTR cardiac amyloidosis
        in patients undergoing TAVI. The diagnosis is based on a positive nuclear scan (PYP, DPD or
        HMDP) and ruling out AL amyloidosis in patients with positive scans. While studies have shown
        no impact of ATTR on prognosis in TAVI patients, there is evidence of poorer quality of life,
        increased in-hospital acute ischemic stroke, increased cardiac and heart failure
        hospitalizations, increased conduction abnormalities, compared to patients without ATTR
        undergoing TAVI.
  
        The prevalence of ATTR in TAVI patients in Jordan and Middle Eastern populations has not been
        previously evaluated. The purpose of this study is to evaluate the prevalence of ATTR cardiac
        amyloidosis in elderly Middle Eastern patients undergoing TAVI and to document the clinical
        characteristics, procedural outcomes and 1 year follow up of such patients compared to
        patients without ATTR.
  observational model: Case-Only
  time perspective: Prospective
  measure: Prevalence of ATTR CA in TAVR patients
  time frame: On admission ( from time of admission to time of discharge from the hospital) and within 10 days.
  description: Consecutive elderly (≥65 years) patients who are undergoing TAVI will be included.
  Patients will be invited to undergo a pyruvate PO4 (PYP) scan. Patients with positive scans will undergo further testing to rule out AL amyloidosis (Free light chain assay, SIFEP, UIFEP). Data collection will include all pertinent clinical characteristics, peri- procedural details.
  measure: Cardiovascular event at One year follow up
  time frame: One year after enrollment: up to 30 days after the passage of 365 days after the TAVR procedure
  description: Events at one year defined as the occurrence of all-cause death, and hospital admission for heart failure or aortic valve reintervention.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ramzi Tabbalat, MD, FACC
  phone: 00962795535522
  email: ramzi_md@yahoo.com
  responsible party type: Sponsor
  mesh term: Aortic Valve Stenosis
  mesh term: Amyloidosis
  mesh term: Constriction, Pathologic