{"doc_desc":{"title":"Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root","idno":"FRESH-PEF60156-en","producers":[{"name":"Emmanuel LANSAC","affiliation":"INSTITUT MEDICO-CHIRURGICAL MONTSOURIS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60156-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60156"},{"agency":"FReSH","code":"FRESH-PEF60156"}]},"title":"Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root","alternate_title":"CAVIAAR"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Isabelle;DI CENTA","PILabo":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS \/ UNIT\u00c9 DE RECHERCHE CLINIQUE PARIS NORD GROUPE HOSPITALIER BICHAT CLAUDE BERNARD","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"055382649","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"isabelle.di-centa@wanadoo.fr","isContact":"Yes"},{"type":"investigator","name":"C\u00e9cile;JOURDAIN","PILabo":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS \/ D\u00c9L\u00c9GATION REGIONALE \u00c0 LA RECHERCHE CLINIQUE D\u00c9L\u00c9GATION REGIONALE \u00c0 LA RECHERCHE CLINIQUE","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Emmanuel;LANSAC","PILabo":"Institut Mutualiste Montsouris \/ D\u00e9partement de Pathologie cardiaque","affiliationName":"INSTITUT MEDICO-CHIRURGICAL MONTSOURIS","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"059432950","role":"pi id"},{"title":"SIREN","uri":"992985036","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"emmanuel.lansac@imm.fr","isContact":"Yes"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14"},{"title":"SIREN","uri":"267500452"}]}]},"distribution_statement":{"contact":[{"name":"Isabelle;DI CENTA","email":"isabelle.di-centa@wanadoo.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Emmanuel;LANSAC","email":"emmanuel.lansac@imm.fr","type":"contact","affiliationName":"INSTITUT MEDICO-CHIRURGICAL MONTSOURIS","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00bea5h57","role":"organisation id","title":"ROR"},{"uri":"992985036","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"operative mortality"},{"keyword":"thromboembolic or haemorrhagic stroke"},{"keyword":"re-operation"},{"keyword":"placement"},{"keyword":"ascending aorta"},{"keyword":"valve endocarditis"},{"keyword":"Health episodes"},{"keyword":"valve"},{"keyword":"death"}],"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":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"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":"","coll_dates":[{"start":"2007-01-01"}],"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\": \"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).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological 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\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"77:- 46 conservations valvulaires- 19 remplacements proth\u00e9tiques m\u00e9caniques- 12 exclusions"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"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":"To be decided if data may be used by academic teams To be decided if data may be used by industrial teams","conditions":"","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"08-08-2014","isContributorPI":"No","contributorName":"Emmanuel LANSAC","contributorAffiliation":"INSTITUT MEDICO-CHIRURGICAL MONTSOURIS","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/caviaar.com\/de\/Home\/Presentations\/Presentations-2014.html"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"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":"Self-administered questionnaire: Input from paper questionnaire (Manual input) with double data entry Interview: Input from paper questionnaire (Manual input) with double data entry Clinical Examinations: handwritten (Manual input) with double data entry Biological Analysis: handwritten (Manual input) with double data entry","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Type of peri-operative and enroliment samples taken: full blood count, haemostasis, blood creatinine, INR, APTT and troponins During follow-up: INR if patient is under AVK","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}