CAVIAAR - Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root

Head :
Lansac Emmanuel, Département de Pathologie cardiaque
Di Centa Isabelle, UNITÉ DE RECHERCHE CLINIQUE PARIS NORD GROUPE HOSPITALIER BICHAT CLAUDE BERNARD
Jourdain Cécile, DÉLÉGATION REGIONALE À LA RECHERCHE CLINIQUE DÉLÉGATION REGIONALE À LA RECHERCHE CLINIQUE

Last update : 07/07/2015 | Version : 3 | ID : 60156

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root
Sign or acronym CAVIAAR
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation Accords CNIL, CPP
General Aspects
Medical area Cardiology
Health determinants Genetic
Keywords operative mortality, thromboembolic or haemorrhagic stroke, re-operation, placement, ascending aorta, valve endocarditis, Health episodes, valve, death
Scientific investigator(s) (Contact)
Name of the director Lansac
Surname Emmanuel
Address 75018 PARIS
Phone + 33 (0)6 64 23 38 25
Email caviaar@orange.fr
Unit Département de Pathologie cardiaque
Organization Institut Mutualiste Montsouris
Name of the director Di Centa
Surname Isabelle
Address 75018 PARIS
Phone + 33 (0)6 08 15 12 92
Email isabelle.di-centa@wanadoo.fr
Unit UNITÉ DE RECHERCHE CLINIQUE PARIS NORD GROUPE HOSPITALIER BICHAT CLAUDE BERNARD
Organization ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
Name of the director Jourdain
Surname Cécile
Address 75011 PARIS
Phone + 33 (0)1 44 84 17 32
Email cecile.jourdain@sls.aphp.fr
Unit DÉLÉGATION REGIONALE À LA RECHERCHE CLINIQUE DÉLÉGATION REGIONALE À LA RECHERCHE CLINIQUE
Organization ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
Collaborations
Participation in projects, networks and consortia Yes
Funding
Funding status Public
Details ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
Governance of the database
Sponsor(s) or organisation(s) responsible APHP
Organisation status Public
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is carried out as part of an interventional study Yes
Details Performed at group level (clusters)
Additional information regarding sample selection. Inclusion method: Prospective
Database objective
Main objective 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
Inclusion criteria - 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).
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 05/2007
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 77:- 46 conservations valvulaires- 19 remplacements prothétiques mécaniques- 12 exclusions
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Paraclinical data
Biological data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Paper self-questionnaire
Face to face interview
Paraclinical data (detail) Imaging
Biological data (detail) 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
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Quality of life/health perception
Procedures
Data collection method 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
Participant monitoring Yes
Details on monitoring of participants Follow-up duration: 20 years
Links to administrative sources No
Promotion and access
Promotion
Link to the document http://caviaar.com/de/Home/Presentations/Presentations-2014.html
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/?term=CAVIAAR
Description List of publications in Pubmed
Access
Terms of data access (charter for data provision, format of data, availability delay) To be decided if data may be used by academic teams To be decided if data may be used by industrial teams
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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