<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/NCT04455165</url>
  </required_header>
  <id_info>
    <org_study_id>CCVT-RVAoMITAVARegistry</org_study_id>
    <nct_id>NCT04455165</nct_id>
  </id_info>
  <brief_title>Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement</brief_title>
  <acronym>RVAOMITAVA</acronym>
  <official_title>Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement Operated at Dijon University Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier La Chartreuse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier La Chartreuse</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>
      Since 2009, positive experiences with right anterior minithoracotomy as an approach to aortic&#xD;
      valve replacement are extensively practiced in our institution. The primary disease process&#xD;
      for which patients are referred remains aortic stenosis. But more and more, we met older&#xD;
      patients with both aortic stenosis and other cardiac pathology (coronary artery disease,&#xD;
      other valvulopathy...). Even if minimally invasive valve surgery has been demonstrated to&#xD;
      significantly improve postoperative course (reduced blood transfusion, pain, hospital lengths&#xD;
      of stay) and to enhance postoperative recovery, when compared with a median sternotomy, it is&#xD;
      however important to have medical data and statistics in order to better understand the&#xD;
      factors influencing morbi-mortality and thereby to continue this improvement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Actual">June 29, 2020</completion_date>
  <primary_completion_date type="Actual">June 29, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>30 days mortality incidence rates</measure>
    <time_frame>30 days</time_frame>
    <description>Mortality from aortic valve replacement to 30 days post-surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30 days morbidity incidence rates</measure>
    <time_frame>30 days</time_frame>
    <description>Morbidity from aortic valve replacement to 30 days post-surgery (major adverse cardiac events)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long-term morbimortality incidence rates</measure>
    <time_frame>10 years</time_frame>
    <description>Morbimortality from aortic valve replacement up to 10 years post-surgery</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Aortic Valve Disease</condition>
  <arm_group>
    <arm_group_label>RVAo MITAVA</arm_group_label>
    <description>Patient operated since 2009 for aortic valve replacement through right anterior minithoracotomy approch in Dijon Burgundy University Hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Aortic valve replacement</intervention_name>
    <description>Aortic valve replacement with or without associated cardiac surgery (coronary bypass, mitral valve surgery,...)</description>
    <arm_group_label>RVAo MITAVA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patient operated for aortic valve replacement with or without associated cardiac&#xD;
        surgery from 2009 in Dijon University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 y-o who underwent aortic valve replacement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie-Catherine MORGANT, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Dijon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiovascular and thoracic surgery Unit - Dijon University Hopital</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier La Chartreuse</investigator_affiliation>
    <investigator_full_name>MORGANT Marie-Catherine</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All patients signed a institutional form prior to the procedure stating that they did not object to the use of their medical data for research purposes. Before inclusion, all patients (or a trusted person) were informed about the study and its objectives. No opposition was expressed.</ipd_description>
  </patient_data>
  <!-- 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/NCT04455165
org study id: CCVT-RVAoMITAVARegistry
nct id: NCT04455165
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since 2009, positive experiences with right anterior minithoracotomy as an approach to aortic
      valve replacement are extensively practiced in our institution. The primary disease process
      for which patients are referred remains aortic stenosis. But more and more, we met older
      patients with both aortic stenosis and other cardiac pathology (coronary artery disease,
      other valvulopathy...). Even if minimally invasive valve surgery has been demonstrated to
      significantly improve postoperative course (reduced blood transfusion, pain, hospital lengths
      of stay) and to enhance postoperative recovery, when compared with a median sternotomy, it is
      however important to have medical data and statistics in order to better understand the
      factors influencing morbi-mortality and thereby to continue this improvement.
observational model: Cohort
time perspective: Retrospective
measure: 30 days mortality incidence rates
time frame: 30 days
description: Mortality from aortic valve replacement to 30 days post-surgery
measure: 30 days morbidity incidence rates
time frame: 30 days
description: Morbidity from aortic valve replacement to 30 days post-surgery (major adverse cardiac events)
measure: Long-term morbimortality incidence rates
time frame: 10 years
description: Morbimortality from aortic valve replacement up to 10 years post-surgery
arm group label: RVAo MITAVA
description: Patient operated since 2009 for aortic valve replacement through right anterior minithoracotomy approch in Dijon Burgundy University Hospital
intervention type: Procedure
intervention name: Aortic valve replacement
description: Aortic valve replacement with or without associated cardiac surgery (coronary bypass, mitral valve surgery,...)
arm group label: RVAo MITAVA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Marie-Catherine MORGANT, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Dijon
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier La Chartreuse
investigator full name: MORGANT Marie-Catherine
investigator title: PI
mesh term: Aortic Valve Disease
sharing ipd: No
ipd description: All patients signed a institutional form prior to the procedure stating that they did not object to the use of their medical data for research purposes. Before inclusion, all patients (or a trusted person) were informed about the study and its objectives. No opposition was expressed.