<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/NCT01691417</url>
  </required_header>
  <id_info>
    <org_study_id>Sleeves-Bickel</org_study_id>
    <nct_id>NCT01691417</nct_id>
  </id_info>
  <brief_title>Pneumatic Sleeves and Congestive Heart Failure</brief_title>
  <acronym>Sleeves-Bickel</acronym>
  <official_title>The Impact of Intermittent Sequential Pneumatic Compression (ISPC) Leg Sleeves on Cardiac Performance in Patients With Congestive Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Galilee Hospital-Nahariya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Galilee Hospital-Nahariya</source>
  <brief_summary>
    <textblock>
      Based on the reversal of the adverse cardiovascular parameters during Laproscopic Surgery and&#xD;
      its influence on cardiac activity in healthy subjects, the investigators expect to improved&#xD;
      cardiac function in patients suffering from congestive heart failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Cardiac Output</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systemic vascular resistance</measure>
  </secondary_outcome>
  <other_outcome>
    <measure>Stroke volume</measure>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <condition>Congestive Heart Failure</condition>
  <arm_group>
    <arm_group_label>Pneumatic Sleeves</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Congestive Heart Failure Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intermittent Sequntial Pnumatic Compression Leg Sleeves</intervention_name>
    <arm_group_label>Congestive Heart Failure Patients</arm_group_label>
    <arm_group_label>Pneumatic Sleeves</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CHF (as clinically evaluated and asessed by TTE)&#xD;
&#xD;
          -  Gave informed consent&#xD;
&#xD;
          -  NYHA Class II-III&#xD;
&#xD;
          -  LVEF equal or less than 40%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who could not sign informed consent&#xD;
&#xD;
          -  NYHA Class IV&#xD;
&#xD;
          -  Oxygen saturation less than 90% under room air&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Western Galilee Hospital</name>
      <address>
        <city>Nahariya</city>
        <zip>22100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 9, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>September 19, 2012</last_update_submitted>
  <last_update_submitted_qc>September 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2012</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 Failure</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/NCT01691417
org study id: Sleeves-Bickel
nct id: NCT01691417
lead sponsor: 
Based on the reversal of the adverse cardiovascular parameters during Laproscopic Surgery and
      its influence on cardiac activity in healthy subjects, the investigators expect to improved
      cardiac function in patients suffering from congestive heart failure.
measure: Cardiac Output
measure: Systemic vascular resistance
measure: Stroke volume
arm group label: Pneumatic Sleeves
arm group type: Experimental
arm group label: Congestive Heart Failure Patients
arm group type: Experimental
intervention type: Device
intervention name: Intermittent Sequntial Pnumatic Compression Leg Sleeves
arm group label: Congestive Heart Failure Patients
arm group label: Pneumatic Sleeves
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Heart Failure