{"doc_desc":{"title":"Registry for Transcatheter Aortic Bioprosthetic Valve Implantation","idno":"FRESH-PEF8661-en","producers":[{"name":"Genevi\u00e8ve MULAK","affiliation":"SOC FRANCAISE DE CARDIOLOGIE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8661-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8661"},{"agency":"FReSH","code":"FRESH-PEF8661"}]},"title":"Registry for Transcatheter Aortic Bioprosthetic Valve Implantation","alternate_title":"FRANCE TAVI"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Herv\u00e9-Yves;LE BRETON","PILabo":"H\u00f4pital \/ Cardiologie Interventionnelle","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"077306090","role":"pi id"},{"title":"ROR","uri":"https:\/\/ror.org\/05qec5a53","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"francetavi@sfcardio.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"ASSOCIATION DE SOUTIEN A LA FILIALE D'IMAGERIE CARDIOVASCULAIRE DE LA SOCIETE FRANCAISE DE CARDIOLOGIE (ASFIC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03vqp1c86","role":"sponsor id"},{"title":"SIREN","uri":"411962640","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ASSOCIATION DE SOUTIEN A LA FILIALE D'IMAGERIE CARDIOVASCULAIRE DE LA SOCIETE FRANCAISE DE CARDIOLOGIE (ASFIC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03vqp1c86"},{"title":"SIREN","uri":"411962640"}]}]},"distribution_statement":{"contact":[{"name":"Herv\u00e9-Yves;LE BRETON","email":"francetavi@sfcardio.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05qec5a53","role":"organisation id","title":"ROR"}]}]},"study_info":{"keywords":[{"keyword":"catheter."},{"keyword":"Valves"}],"topics":[{"topic":"Cardiology and vascular medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4455c187-2f2f-4cd1-a4dd-449f59d73b39"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D002309"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"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":"","coll_dates":[{"start":"2013-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Aged 18 years or over; - Undergoing a valve change by transcatheter implantation; - Individuals that gave clear consent.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":""}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"4,016 patients enrolled in 47 centres on 03\/06\/2014."},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Morbidity registry"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"22-04-2014","lastUpdatedAuto":null,"lastUpdatedManual":"12-05-2015","isContributorPI":"No","contributorName":"Genevi\u00e8ve MULAK","contributorAffiliation":"ASSOCIATION DE SOUTIEN A LA FILIALE D'IMAGERIE CARDIOVASCULAIRE DE LA SOCIETE FRANCAISE DE CARDIOLOGIE (ASFIC)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/PUBMED-FRANCETAVI"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Private non-profit"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Massy, Caen, Rouen, Brest, Lille, Marseilles, Toulouse, Strasbourg, Saint-Laurent-du-var, Rennes, Le Chesnay, Nantes, Saint-Denis, Paris, Caluire-et-cuire, Angers, Clermont-Ferrand, Tours, Montpellier, Villeurbanne, Bron, Bois-Bernard, Amiens, Montpellier, Bordeaux, Dijon, Grenoble, Poitiers, Pessac, Metz, Le Plessis-Robinson, Mulhouse, Vandoeuvre-Lesnancy and Saint-Etienne."},"dataTypes":{"clinicalDataDetails":"Functional status, medical history, background, pre-implantation assessment, implantation procedure, hospital discharge, complications, vital status, treatment.","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}