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<docDscr>
  <citation>
    <titlStmt>
      <titl>Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root</titl>
      <IDNo>FRESH-PEF60156-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="INSTITUT MEDICO-CHIRURGICAL MONTSOURIS" role="">Emmanuel LANSAC</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root            </titl>
      <altTitl>
                    CAVIAAR                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF60156-en            </IDNo>
      <IDNo agency="PEF">
                    60156                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF60156                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Isabelle DI CENTA                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)">
        <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
        <ExtLink title="SIREN" URI="267500452" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Cécile JOURDAIN                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)">
        <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
        <ExtLink title="SIREN" URI="267500452" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Emmanuel LANSAC                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT MEDICO-CHIRURGICAL MONTSOURIS">
        <ExtLink title="ROR" URI="https://ror.org/00bea5h57" role="organisation id"/>
        <ExtLink title="SIREN" URI="992985036" role="organisation id"/>
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      <othId affiliation="" type="">
                                    </othId>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)" email="isabelle.di-centa@wanadoo.fr">
                    Isabelle;DI CENTA
                                            <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="267500452" role="organisation id"/>
                                    </contact>
      <contact affiliation="INSTITUT MEDICO-CHIRURGICAL MONTSOURIS" email="emmanuel.lansac@imm.fr">
                    Emmanuel;LANSAC
                                            <ExtLink title="ROR" URI="https://ror.org/00bea5h57" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="992985036" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    operative mortality</keyword>
      <keyword vocab="" vocabURI="">
                    thromboembolic or haemorrhagic stroke</keyword>
      <keyword vocab="" vocabURI="">
                    re-operation</keyword>
      <keyword vocab="" vocabURI="">
                    placement</keyword>
      <keyword vocab="" vocabURI="">
                    ascending aorta</keyword>
      <keyword vocab="" vocabURI="">
                    valve endocarditis</keyword>
      <keyword vocab="" vocabURI="">
                    Health episodes</keyword>
      <keyword vocab="" vocabURI="">
                    valve</keyword>
      <keyword vocab="" vocabURI="">
                    death</keyword>
      <topcClas vocab="health theme">
                        Cardiology and vascular medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/4455c187-2f2f-4cd1-a4dd-449f59d73b39"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D002309"/>
                                                </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">General objective: to demonstrate in a prospective open and multricentric cohort study that aortic valve sparing for patients with aortic root aneurysms and/or dystrophic aortic insufficiency is associated with a 45% increase of 3 year, 5 year, 10 year, 15 year and 20 year-survival rate without increased mortality or morbidity events when compared to mechanical valve replacement (surgical treatment reference). Morbidity and mortality is defined as the occurrence of at least one of the composite endpoint events: death, re-operation and/or re-hospitalisation for infection, bleeding event, thromboembolic event or heart failure Secondary objectives: - To evaluate and compare between both patient groups: the rate of immediate post-operation complications associated with a 3 year, 5 year, 10 year, 15 year and 20 year-survival rate without mortality or morbidity events when evaluated on composite criteria, the changes in quality of life during follow-up using a standardised questionnaire, validated by cardiac surgery, modified SF12 Questionnaire - to evaluate the impact of a teaching programme for a new standardised surgical technique on morbidity and mortality from each investigating surgeon's learning curve and on long-term outcomes (programme combining theoretical and video-assisted surgical procedure training on heart anatomy, first patient surgical mentoring) - To set predictive sonographic criteria: the feasibility of valve repair with promising immediate and long-term postoperative results from early diagnosis of criteria composite outcome: To evaluate the sensitivity and specificity of ultrasound parameters, notably on the risk of reoperation and valvular complications - To assess the impact of clinical monitoring and imaging on operated patients with aortic root dystrophy in order to propose a post-operative care protocol that meets cost-benefit objectives</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2007-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">over 18 years of age;  - aortic root aneurysms without aortic insufficiency or with dystrophic aortic insufficiency regardless of stage (including Marfan and bicuspid diseases), with indications for surgery conformed to American Heart Association or European Society of Cardiology guidelines or dystrophic aortic insufficiency (bicuspid or tricuspid valves) with no aortic root aneurysm with indications for surgery conformed to American Heart Association or European Society of Cardiology; - scheduled valve repair surgery with annuloplasty according to mechanical valve replacement CAVIAAR study protocol; - Signed information letter and informed consent; - covered by social security insurance or access to CMU (beneficiary or assignee).                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>77:- 46 conservations valvulaires- 19 remplacements prothétiques mécaniques- 12 exclusions</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>To be decided if data may be used by academic teams To be decided if data may be used by industrial teams</restrctn>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
