<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/NCT01669551</url>
  </required_header>
  <id_info>
    <org_study_id>UPenn 815656</org_study_id>
    <nct_id>NCT01669551</nct_id>
  </id_info>
  <brief_title>A Phase 1 Feasbility Study Of Volume Intracardiac Echo In Assessment Of Patients With Structural And Valvular Heart Disease Undergoing Percutaneous Transcatheter Therapy</brief_title>
  <official_title>A Phase 1 Feasbility Study Of Volume Intracardiac Echo In Assessment Of Patients With Structural And Valvular Heart Disease Undergoing Percutaneous Transcatheter Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare 3 dimensional intracardiac echo (ICE) with 2 dimensional ICE or&#xD;
      transesophageal echo in patients with structural and valvular heart disease who are already&#xD;
      scheduled to undergo a percutaneous intervention. Specifically those patients would be those&#xD;
      scheduled for a PFO or ASD repair, mitral balloon valvuloplasty, diagnostic cardiac&#xD;
      catheterization assessment of aortic stenosis and those undergoing transcatheter aortic valve&#xD;
      replacement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Comparison of volume intracardiac echo imaging to 2 dimensional echo</measure>
    <time_frame>Comparison study</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Structural and Valvular Heart Disease</condition>
  <arm_group>
    <arm_group_label>Structural or Valvular Heart Disease</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with structural or valvular heart disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients in the study population referred to the cardiac catheterization laboratory&#xD;
             for a percutaneous procedure to treat structural or valvular heart disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Class IV CHF, inadequate femoral access, coagulation abnormalities, intracariac&#xD;
             thrombus or DVT&#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_official>
    <last_name>Howard Herrmann, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>December 8, 2014</last_update_submitted>
  <last_update_submitted_qc>December 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 10, 2014</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>Heart Diseases</mesh_term>
    <mesh_term>Heart Valve Diseases</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/NCT01669551
org study id: UPenn 815656
nct id: NCT01669551
lead sponsor: 
has dmc: No
This study will compare 3 dimensional intracardiac echo (ICE) with 2 dimensional ICE or
      transesophageal echo in patients with structural and valvular heart disease who are already
      scheduled to undergo a percutaneous intervention. Specifically those patients would be those
      scheduled for a PFO or ASD repair, mitral balloon valvuloplasty, diagnostic cardiac
      catheterization assessment of aortic stenosis and those undergoing transcatheter aortic valve
      replacement.
observational model: Case-Only
time perspective: Prospective
measure: Comparison of volume intracardiac echo imaging to 2 dimensional echo
time frame: Comparison study
arm group label: Structural or Valvular Heart Disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Howard Herrmann, M.D.
role: Principal Investigator
affiliation: University of Pennsylvania
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Valve Diseases