<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/NCT03279029</url>
  </required_header>
  <id_info>
    <org_study_id>2017-08</org_study_id>
    <secondary_id>2017-A00680-53</secondary_id>
    <nct_id>NCT03279029</nct_id>
  </id_info>
  <brief_title>Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases</brief_title>
  <official_title>Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      To investigate histological structure and molecular changes involved on the onset of AVD&#xD;
      after left ventricular assist device (LVAD) implantation and to compare them with those of&#xD;
      patients operated on for severe aortic regurgitation.&#xD;
&#xD;
      Methods: Bridge-to-transplant patients with AVD post-LVAD implantation are included. Patients&#xD;
      operated on for severe aortic regurgitation are included as control. Clinical and TTE data&#xD;
      are compiled. Samples of aortic valve are collected at the time of the intervention.&#xD;
      RNA-sequencing analysis is performed in LVAD patients and variations of gene expression are&#xD;
      validated by real time qPCR in both. Blood sampling are performed pre-operatively and at&#xD;
      one-month follow up to assess the plasma level of previously identified gene modulators.&#xD;
      In-vitro studies exposing VICs and VECs to several mechanical stimuli are performed for&#xD;
      validation.&#xD;
&#xD;
      Conclusion(s) Taking together, the in-vivo and in-vitro models would provide important&#xD;
      information for the understanding of valve remodeling and disease. ECM gene modulators could&#xD;
      represent pertinent molecular targets to stop the progression of AVD&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    2 patients included only&#xD;
  </why_stopped>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Anticipated">August 8, 2023</completion_date>
  <primary_completion_date type="Actual">September 14, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>blood sample</measure>
    <time_frame>24 months</time_frame>
    <description>RNA-sequencing analysis</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Aortic Valve Regurgitation Acquired</condition>
  <arm_group>
    <arm_group_label>patients with aortic valve disease (AVD).</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with left ventricular assist device (LVAD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>blood samples</intervention_name>
    <description>blood samples</description>
    <arm_group_label>patients with aortic valve disease (AVD).</arm_group_label>
    <arm_group_label>patients with left ventricular assist device (LVAD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>biopsy</intervention_name>
    <description>biopsy of aortic valve</description>
    <arm_group_label>patients with aortic valve disease (AVD).</arm_group_label>
    <arm_group_label>patients with left ventricular assist device (LVAD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with long-term left-ventricular assistance awaiting transplant&#xD;
&#xD;
          -  Patients with severe aortic surgical spring deficiency&#xD;
&#xD;
          -  Major Patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor Patient&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  Major under guardianship&#xD;
&#xD;
          -  People in emergencies&#xD;
&#xD;
          -  Persons not covered by the social security scheme&#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>alexis THERON</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique Hopitaux De Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</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>
    <mesh_term>Aortic Valve Insufficiency</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/NCT03279029
org study id: 2017-08
secondary id: 2017-A00680-53
nct id: NCT03279029
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate histological structure and molecular changes involved on the onset of AVD
      after left ventricular assist device (LVAD) implantation and to compare them with those of
      patients operated on for severe aortic regurgitation.

      Methods: Bridge-to-transplant patients with AVD post-LVAD implantation are included. Patients
      operated on for severe aortic regurgitation are included as control. Clinical and TTE data
      are compiled. Samples of aortic valve are collected at the time of the intervention.
      RNA-sequencing analysis is performed in LVAD patients and variations of gene expression are
      validated by real time qPCR in both. Blood sampling are performed pre-operatively and at
      one-month follow up to assess the plasma level of previously identified gene modulators.
      In-vitro studies exposing VICs and VECs to several mechanical stimuli are performed for
      validation.

      Conclusion(s) Taking together, the in-vivo and in-vitro models would provide important
      information for the understanding of valve remodeling and disease. ECM gene modulators could
      represent pertinent molecular targets to stop the progression of AVD
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: blood sample
time frame: 24 months
description: RNA-sequencing analysis
arm group label: patients with aortic valve disease (AVD).
arm group type: Experimental
arm group label: patients with left ventricular assist device (LVAD
arm group type: Experimental
intervention type: Biological
intervention name: blood samples
description: blood samples
arm group label: patients with aortic valve disease (AVD).
arm group label: patients with left ventricular assist device (LVAD
intervention type: Biological
intervention name: biopsy
description: biopsy of aortic valve
arm group label: patients with aortic valve disease (AVD).
arm group label: patients with left ventricular assist device (LVAD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: alexis THERON
role: Principal Investigator
affiliation: Assistance Publique Hopitaux De Marseille
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Valve Diseases
mesh term: Aortic Valve Insufficiency