<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/NCT02210351</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-13-0829-DS-CTIL</org_study_id>
    <nct_id>NCT02210351</nct_id>
  </id_info>
  <brief_title>Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).</brief_title>
  <official_title>Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The asses and evaluate whether trans apical access for TAVR is associated with apical&#xD;
      dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Anticipated">January 2017</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in left ventricle ejection fraction</measure>
    <time_frame>two months after the surgery</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Severe Symptomatic Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>MRI test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI test</intervention_name>
    <arm_group_label>MRI test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area&#xD;
             of 0.6 cm2/m2 by echocardiography.&#xD;
&#xD;
          2. Symptomatic patients with aortic stenosis referred for medically indicated AVR&#xD;
&#xD;
          3. Signed informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to sign written informed consent.&#xD;
&#xD;
          2. Abnormal Apical dysfunction at baseline&#xD;
&#xD;
          3. LVEF &lt; 20%&#xD;
&#xD;
          4. Pregnancy or breast feeding.&#xD;
&#xD;
          5. Need for emergency surgery for any reason.&#xD;
&#xD;
          6. Any case in which the practicing physician asserts that enrollment in the protocol&#xD;
             will&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Danny Spiegelstein, Dr</last_name>
    <phone>972-35307339</phone>
    <email>Danny.Spiegelstein@sheba.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Leviev Heart Center, Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Danny Spiegelstein, Dr</last_name>
      <phone>972-35307339</phone>
      <email>Danny.Spiegelstein@sheba.health.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Danny Spiegelstein</investigator_full_name>
    <investigator_title>Dr. Danny Spiegelstein, Physician</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT02210351
org study id: SHEBA-13-0829-DS-CTIL
nct id: NCT02210351
lead sponsor: 
has dmc: No
The asses and evaluate whether trans apical access for TAVR is associated with apical
      dysfunction.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change in left ventricle ejection fraction
time frame: two months after the surgery
arm group label: MRI test
arm group type: Experimental
intervention type: Device
intervention name: MRI test
arm group label: MRI test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Danny Spiegelstein, Dr
phone: 972-35307339
email: Danny.Spiegelstein@sheba.health.gov.il
facility: 
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Danny Spiegelstein
investigator title: Dr. Danny Spiegelstein, Physician
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic