<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/NCT03027804</url>
  </required_header>
  <id_info>
    <org_study_id>CN-17-001</org_study_id>
    <nct_id>NCT03027804</nct_id>
  </id_info>
  <brief_title>Ross Operation Failure Database</brief_title>
  <acronym>ROFDA</acronym>
  <official_title>Database on Ross Operation Failures and Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Cardiologique du Nord</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Golden Jubilee National Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pontifícia Universidade Católica do Paraná</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ospedale San Donato</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Groupe Hospitalier Pitie-Salpetriere</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Cardiologique du Nord</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A large multicentric registry to obtain data to analyse the pulmonary autograft (PA) failure&#xD;
      phenomenon and feed more complex biomechanical models to be integrated with clinical imaging&#xD;
      with the final aim to predict Ross operation's outcomes and define strategies to ameliorate&#xD;
      its results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On the basis of the current knowledge on the outcomes of Ross Operation we aim to create a&#xD;
      large multi centric registry in order to obtain data on the preoperative intraoperative&#xD;
      management of these patients and on the postoperative long-term results of this procedure.&#xD;
&#xD;
      Patients data will be entered by the investigators in an electronic database Preoperative&#xD;
      variables will include age, comorbidities, functional status, indications for surgery,&#xD;
      morphology of the aortic valve Additional morphological data and aortic and pulmonary&#xD;
      measurements will be taken intraoperatively Postoperative follow-up data including both&#xD;
      clinical outcomes (mortality, reoperation for pulmonary autograft failure, major cardiac&#xD;
      events, stroke, infection) and morphological measurements by means of CT scan or&#xD;
      echocardiography, will be inserted.&#xD;
&#xD;
      Quality of life by means of SF12 and Minnesota living with heart failure questionnaire and&#xD;
      EQ-5D score will be collected.&#xD;
&#xD;
      Follow-up endpoints are at discharge, 1 year 5 years 10 years 15 years and 20 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    This study has been changed in systematic review and meta-analysis&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 1, 2018</start_date>
  <completion_date type="Anticipated">March 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>from inclusion to 20 years follow-up</time_frame>
    <description>Death from any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiac Death</measure>
    <time_frame>from inclusion to 20 years follow-up</time_frame>
    <description>Mortality due to cardiac cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reoperation for Pulmonary Autograft Failure</measure>
    <time_frame>from inclusion to 20 years follow-up</time_frame>
    <description>Need for reoperation due to failure of pulmonary autograft or valve degeneration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke</measure>
    <time_frame>from inclusion to 20 years follow-up</time_frame>
    <description>neurological stroke with impairment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rehospitalization for heart failure</measure>
    <time_frame>from inclusion to 20 years follow-up</time_frame>
    <description>Readmission to hospital for heart failure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life-1</measure>
    <time_frame>from inclusion to 20 years follow-up</time_frame>
    <description>Quality of life as measured with SF-12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life-2</measure>
    <time_frame>from inclusion to 20 years follow-up</time_frame>
    <description>Quality of life as measured with Minnesota living with heart failure questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life-3</measure>
    <time_frame>from inclusion to 20 years follow-up</time_frame>
    <description>Quality of life as measured withEQ 5D score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>postoperative period (1-30 days)</time_frame>
    <description>Combined outcome including bleeding, arrhythmia, respiratory failure, renal failure</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Ross Operation</condition>
  <condition>Pulmonary Autograft</condition>
  <condition>Structural Valve Degeneration</condition>
  <arm_group>
    <arm_group_label>Ross Operation</arm_group_label>
    <description>Patients undergone Ross Operation. Patients requiring reoperation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ross Operation</intervention_name>
    <description>Replacement of the aortic valve by means of pulmonary artery autograft</description>
    <arm_group_label>Ross Operation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergone (or undergoing) to Ross Operation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergone (or undergoing) to Ross Operation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients requiring combined cardiac surgical procedure in association to Ross&#xD;
             Operation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francesco Nappi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Cardiologique du Nord</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Cardiologique Du Nord</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</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/NCT03027804
org study id: CN-17-001
nct id: NCT03027804
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
A large multicentric registry to obtain data to analyse the pulmonary autograft (PA) failure
      phenomenon and feed more complex biomechanical models to be integrated with clinical imaging
      with the final aim to predict Ross operation's outcomes and define strategies to ameliorate
      its results.
On the basis of the current knowledge on the outcomes of Ross Operation we aim to create a
      large multi centric registry in order to obtain data on the preoperative intraoperative
      management of these patients and on the postoperative long-term results of this procedure.

      Patients data will be entered by the investigators in an electronic database Preoperative
      variables will include age, comorbidities, functional status, indications for surgery,
      morphology of the aortic valve Additional morphological data and aortic and pulmonary
      measurements will be taken intraoperatively Postoperative follow-up data including both
      clinical outcomes (mortality, reoperation for pulmonary autograft failure, major cardiac
      events, stroke, infection) and morphological measurements by means of CT scan or
      echocardiography, will be inserted.

      Quality of life by means of SF12 and Minnesota living with heart failure questionnaire and
      EQ-5D score will be collected.

      Follow-up endpoints are at discharge, 1 year 5 years 10 years 15 years and 20 years.
observational model: Other
time perspective: Other
measure: Survival
time frame: from inclusion to 20 years follow-up
description: Death from any cause
measure: Cardiac Death
time frame: from inclusion to 20 years follow-up
description: Mortality due to cardiac cause
measure: Reoperation for Pulmonary Autograft Failure
time frame: from inclusion to 20 years follow-up
description: Need for reoperation due to failure of pulmonary autograft or valve degeneration
measure: Stroke
time frame: from inclusion to 20 years follow-up
description: neurological stroke with impairment
measure: Rehospitalization for heart failure
time frame: from inclusion to 20 years follow-up
description: Readmission to hospital for heart failure
measure: Quality of life-1
time frame: from inclusion to 20 years follow-up
description: Quality of life as measured with SF-12
measure: Quality of life-2
time frame: from inclusion to 20 years follow-up
description: Quality of life as measured with Minnesota living with heart failure questionnaire
measure: Quality of life-3
time frame: from inclusion to 20 years follow-up
description: Quality of life as measured withEQ 5D score
measure: Postoperative complications
time frame: postoperative period (1-30 days)
description: Combined outcome including bleeding, arrhythmia, respiratory failure, renal failure
arm group label: Ross Operation
description: Patients undergone Ross Operation. Patients requiring reoperation
intervention type: Procedure
intervention name: Ross Operation
description: Replacement of the aortic valve by means of pulmonary artery autograft
arm group label: Ross Operation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 80 Years
healthy volunteers: No
last name: Francesco Nappi, MD
role: Principal Investigator
affiliation: Centre Cardiologique du Nord
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided