ITMO public health
Last update : 11/02/2015 | Version : 3 | ID : 8661
| General | |
| Identification | |
| Detailed name | Registry for Transcatheter Aortic Bioprosthetic Valve Implantation |
| Sign or acronym | FRANCE TAVI |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL no. 912449 on 20/12/2012. |
| General Aspects | |
| Medical area |
Cardiology |
| Health determinants |
Iatrogenic |
| Keywords | catheter., Valves |
| Scientific investigator(s) (Contact) | |
| Name of the director | Le Breton |
| Surname | Hervé Yves |
| Address | Hôpital Ponchaillou Cardiologie Interventionnelle 35033 RENNES Cedex |
| Phone | +33 (0)2 29 92 25 05 |
| francetavi@sfcardio.fr | |
| Unit | Cardiologie Interventionnelle |
| Organization | Hôpital |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | French Cardiology Society. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Société Française de Cardiologie |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Morbidity registers |
| Database objective | |
| Main objective |
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. |
| Inclusion criteria |
- Aged 18 years or over;
- Undergoing a valve change by transcatheter implantation; - Individuals that gave clear consent. |
| 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 | 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. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 02/2013 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 4,016 patients enrolled in 47 centres on 03/06/2014. |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Functional status, medical history, background, pre-implantation assessment, implantation procedure, hospital discharge, complications, vital status, treatment. |
| Paraclinical data (detail) | Ultrasound. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up at one month then every year. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/PUBMED-FRANCETAVI |
| Description | Liste des publications dans Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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