<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/NCT02186691</url>
  </required_header>
  <id_info>
    <org_study_id>2014-06</org_study_id>
    <nct_id>NCT02186691</nct_id>
  </id_info>
  <brief_title>Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot</brief_title>
  <official_title>Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Long term survival of patients with repaired tetralogy of Fallot is excellent (about 85% at&#xD;
      35 year-old). However these patients are exposed to residual pulmonary stenosis (PS) and/or&#xD;
      pulmonary regurgitation (PR). It is well established that these lesions can lead to&#xD;
      irreversible sequelae such as right ventricle dilatation and dysfunction. Pulmonary valve&#xD;
      replacement technique was developed to avoid long term right ventricular dysfunction.&#xD;
      Pulmonary valve replacement indications are based upon the presence of symptoms at exercise&#xD;
      and/or morphological or functional parameters such as severe pulmonary regurgitation with&#xD;
      right ventricle dilatation/dysfunction. The best timing of such intervention is still&#xD;
      underdebate with the main aim of having the right balance between avoiding long term sequelae&#xD;
      of PR or PS and being the latter possible to push ahead the need for new intervention. Recent&#xD;
      publication showed that myocardial diffuse fibrosis can contribute to irreversible alteration&#xD;
      of myocardial contractility. Quantification of diffuse fibrosis by magnetic resonance imaging&#xD;
      is feasible and could help the physician to best determine the right timing for PVR in this&#xD;
      population of patients. Cardiac function assessment at rest and during exercise is possible&#xD;
      using MR and our centre has developed a program for cardiac exercise during MRI. This could&#xD;
      help to detect infra clinic abnormality and to analyse myocardial adaptation during exercise.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2014</start_date>
  <completion_date type="Actual">April 12, 2023</completion_date>
  <primary_completion_date type="Actual">October 18, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>determination of the quantity of diffuse myocardial fibrosis</measure>
    <time_frame>2.5 years</time_frame>
    <description>determine if the quantity of diffuse myocardial fibrosis measured by cardiac magnetic resonnance (CMR) compare to baseline measure is correlated with decrease of RV volume and increase in RV and LV ejection fraction after PVR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>determination of contractile reserve</measure>
    <time_frame>2.5 years</time_frame>
    <description>determine if contractile reserve measured by cardiac magnetic resonnance (CMR) compare to baseline measure is correlated with decrease of RV volume and increase in RV and LV ejection fraction after PVR</description>
  </secondary_outcome>
  <other_outcome>
    <measure>determnation of variation fibrosis biomarkers</measure>
    <time_frame>2.5 years</time_frame>
    <description>determine if the fibrosis biomarkers dosage compare to baseline measure is correlated with decrease of RV volume and increase in RV and LV ejection fraction after PVR</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Tetralogy of Fallot With Pulmonary Stenosis</condition>
  <arm_group>
    <arm_group_label>RV and LV ejection fraction assesment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>assesment RV and LV ejection fraction after PVR measured by MRI</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <arm_group_label>RV and LV ejection fraction assesment</arm_group_label>
    <other_name>assesment RV and LV ejection fraction after PVR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - older than 14 year-old, with repaired tetralogy of Fallot requiring pulmonary valve&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  liver failure, kidney failure,&#xD;
&#xD;
          -  contra indication to MRI study,&#xD;
&#xD;
          -  non-affiliated to the national health care program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beatrice BONELLO, MD</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>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pulmonary valve replacement</keyword>
  <keyword>tetralogy of Fallot</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tetralogy of Fallot</mesh_term>
    <mesh_term>Pulmonary Valve Stenosis</mesh_term>
    <mesh_term>Ventricular Remodeling</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/NCT02186691
org study id: 2014-06
nct id: NCT02186691
lead sponsor: 
has dmc: No
Long term survival of patients with repaired tetralogy of Fallot is excellent (about 85% at
      35 year-old). However these patients are exposed to residual pulmonary stenosis (PS) and/or
      pulmonary regurgitation (PR). It is well established that these lesions can lead to
      irreversible sequelae such as right ventricle dilatation and dysfunction. Pulmonary valve
      replacement technique was developed to avoid long term right ventricular dysfunction.
      Pulmonary valve replacement indications are based upon the presence of symptoms at exercise
      and/or morphological or functional parameters such as severe pulmonary regurgitation with
      right ventricle dilatation/dysfunction. The best timing of such intervention is still
      underdebate with the main aim of having the right balance between avoiding long term sequelae
      of PR or PS and being the latter possible to push ahead the need for new intervention. Recent
      publication showed that myocardial diffuse fibrosis can contribute to irreversible alteration
      of myocardial contractility. Quantification of diffuse fibrosis by magnetic resonance imaging
      is feasible and could help the physician to best determine the right timing for PVR in this
      population of patients. Cardiac function assessment at rest and during exercise is possible
      using MR and our centre has developed a program for cardiac exercise during MRI. This could
      help to detect infra clinic abnormality and to analyse myocardial adaptation during exercise.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: determination of the quantity of diffuse myocardial fibrosis
time frame: 2.5 years
description: determine if the quantity of diffuse myocardial fibrosis measured by cardiac magnetic resonnance (CMR) compare to baseline measure is correlated with decrease of RV volume and increase in RV and LV ejection fraction after PVR
measure: determination of contractile reserve
time frame: 2.5 years
description: determine if contractile reserve measured by cardiac magnetic resonnance (CMR) compare to baseline measure is correlated with decrease of RV volume and increase in RV and LV ejection fraction after PVR
measure: determnation of variation fibrosis biomarkers
time frame: 2.5 years
description: determine if the fibrosis biomarkers dosage compare to baseline measure is correlated with decrease of RV volume and increase in RV and LV ejection fraction after PVR
arm group label: RV and LV ejection fraction assesment
arm group type: Experimental
description: assesment RV and LV ejection fraction after PVR measured by MRI
intervention type: Other
intervention name: MRI
arm group label: RV and LV ejection fraction assesment
other name: assesment RV and LV ejection fraction after PVR
criteria: 
gender: All
minimum age: 14 Years
maximum age: 90 Years
healthy volunteers: No
last name: Beatrice BONELLO, MD
role: Principal Investigator
affiliation: Assistance Publique Hopitaux De Marseille
facility: 
country: France
responsible party type: Sponsor
mesh term: Tetralogy of Fallot
mesh term: Pulmonary Valve Stenosis
mesh term: Ventricular Remodeling