<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/NCT03259945</url>
  </required_header>
  <id_info>
    <org_study_id>BOUCHOT 2017</org_study_id>
    <nct_id>NCT03259945</nct_id>
  </id_info>
  <brief_title>Retrospective Observational Study of Patients With a Sutureless Aortic Valve Implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU</brief_title>
  <acronym>ORVAS</acronym>
  <official_title>Retrospective Observational Study of Patients With a Sutureless Aortic Valve Implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The incidence of aortic valve disease is increasing steadily because of the ageing of the&#xD;
      population. At a certain stage, replacement of the aortic valve improves symptoms and thus&#xD;
      the quality of life of patients.&#xD;
&#xD;
      Surgical aortic valve replacement is the &quot; gold standard &quot;. The procedure involves stopping&#xD;
      the heart and setting up cardiopulmonary bypass (CPB) to ensure the oxygenation of tissues.&#xD;
&#xD;
      The reference technique consists in suturing a prosthetic valve to the aortic annulus so as&#xD;
      to restore normal function. This technique has very good results in the long term. The&#xD;
      elective approach is sternotomy, which has certain drawbacks: post-operative pain, risk of&#xD;
      infection, psychological trauma of a major incision. In recent years an alternative approach,&#xD;
      right minithoracotomy, has been proposed. The drawback to this approach is that it increases&#xD;
      aortic cross-clamp time and CPB time.&#xD;
&#xD;
      More recently, new prosthetic valves, so-called &quot;sutureless&quot; or &quot;rapid deployment&quot; valves&#xD;
      have become available. The main advantage of these valves is that they are easy to implant,&#xD;
      as they do not require or need just a few sutures. As a result heart-arrest time is shorter,&#xD;
      post-operative inflammatory syndrome is less frequent and transfusion needs are reduced.&#xD;
&#xD;
      However, these valves have a metallic stent to fix the valve in place by pressing against the&#xD;
      aortic annulus, which may give rise to intra-cardiac conduction disorders. Yet, very few&#xD;
      studies have been conducted on this subject.&#xD;
&#xD;
      The investigators wish to evaluate these conduction disorders in a cohort of patients&#xD;
      operated on in this Department with this sutureless or rapid deployment valve technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 16, 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">February 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>presence of conduction disorders on postoperative ECGs</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Patients With a Sutureless Aortic Valve</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>demographic and clinical data</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Review of ECGs</intervention_name>
    <description>nature and frequency of proven conduction disorders</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with a sutureless aortic valve implanted in the Cardiovascular and Thoracic&#xD;
        Surgery Department of Dijon CHU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients who underwent implantation of a Suturless valve since 2015 (Intuity Elite&#xD;
        Edwards or Perceval S Liva Nova)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with a pacemaker&#xD;
&#xD;
          -  patients who underwent double valve replacement&#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>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier BOUCHOT</last_name>
      <phone>0380293352</phone>
      <email>OLIVIER.BOUCHOT@CHU-DIJON.FR</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03259945
org study id: BOUCHOT 2017
nct id: NCT03259945
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The incidence of aortic valve disease is increasing steadily because of the ageing of the
      population. At a certain stage, replacement of the aortic valve improves symptoms and thus
      the quality of life of patients.

      Surgical aortic valve replacement is the " gold standard ". The procedure involves stopping
      the heart and setting up cardiopulmonary bypass (CPB) to ensure the oxygenation of tissues.

      The reference technique consists in suturing a prosthetic valve to the aortic annulus so as
      to restore normal function. This technique has very good results in the long term. The
      elective approach is sternotomy, which has certain drawbacks: post-operative pain, risk of
      infection, psychological trauma of a major incision. In recent years an alternative approach,
      right minithoracotomy, has been proposed. The drawback to this approach is that it increases
      aortic cross-clamp time and CPB time.

      More recently, new prosthetic valves, so-called "sutureless" or "rapid deployment" valves
      have become available. The main advantage of these valves is that they are easy to implant,
      as they do not require or need just a few sutures. As a result heart-arrest time is shorter,
      post-operative inflammatory syndrome is less frequent and transfusion needs are reduced.

      However, these valves have a metallic stent to fix the valve in place by pressing against the
      aortic annulus, which may give rise to intra-cardiac conduction disorders. Yet, very few
      studies have been conducted on this subject.

      The investigators wish to evaluate these conduction disorders in a cohort of patients
      operated on in this Department with this sutureless or rapid deployment valve technique.
observational model: Case-Only
time perspective: Retrospective
measure: presence of conduction disorders on postoperative ECGs
time frame: through study completion, an average of 2 years
intervention type: Other
intervention name: Data collection
description: demographic and clinical data
intervention type: Other
intervention name: Review of ECGs
description: nature and frequency of proven conduction disorders
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided