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<docDscr>
  <citation>
    <titlStmt>
      <titl>Registry for Transcatheter Aortic Bioprosthetic Valve Implantation</titl>
      <IDNo>FRESH-PEF8661-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="SOC FRANCAISE DE CARDIOLOGIE" role="">Geneviève MULAK</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Registry for Transcatheter Aortic Bioprosthetic Valve Implantation            </titl>
      <altTitl>
                    FRANCE TAVI                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF8661-en            </IDNo>
      <IDNo agency="PEF">
                    8661                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF8661                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Hervé-Yves LE BRETON                                                                                </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES">
        <ExtLink title="ROR" URI="https://ror.org/05qec5a53" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            ASSOCIATION DE SOUTIEN A LA FILIALE D&amp;#039;IMAGERIE CARDIOVASCULAIRE DE LA SOCIETE FRANCAISE DE CARDIOLOGIE (ASFIC)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            ASSOCIATION DE SOUTIEN A LA FILIALE D&amp;#039;IMAGERIE CARDIOVASCULAIRE DE LA SOCIETE FRANCAISE DE CARDIOLOGIE (ASFIC)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES" email="francetavi@sfcardio.fr">
                    Hervé-Yves;LE BRETON
                                            <ExtLink title="ROR" URI="https://ror.org/05qec5a53" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    catheter.</keyword>
      <keyword vocab="" vocabURI="">
                    Valves</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">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Main objective:: To identify all patients undergoing a valve change by transcatheter implantation, who fulfil the selection and technical criteria, that accept the scheduled assessments as part of the disease and who agreed to participate in the study and survival rate assessment at one year. Secondary objectives: To collect epidemiological data on this new technique.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2013-01-01"/>
      <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">Aged 18 years or over; - Undergoing a valve change by transcatheter implantation; - Individuals that gave clear consent.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <targetSampleSize>
        <sampleSizeFormula>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </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">
                        Morbidity registry                    </notes>
    <anlyInfo>
      <respRate>4,016 patients enrolled in 47 centres on 03/06/2014.</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Contact the principal investigator</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
