Last update : 09/05/2017 | Version : 2 | ID : 60142
General | |
Identification | |
Detailed name | Medico-Economic Evaluation of Automatic Implantable Defibrillator |
Sign or acronym | EVADEF |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
General Aspects | |
Medical area |
Cardiology |
Keywords | psychological impact, Complications, death |
Scientific investigator(s) (Contact) | |
Name of the director | Marijon |
Surname | Eloi |
Phone | +33 (0)1 53 98 79 63 |
eloi_marijon@yahoo.fr | |
Name of the director | Le Heuzey |
Surname | Jean-Yves |
Address | 75908 PARIS |
Phone | +33 (0)1 56 09 37 01 |
jean-yves.le-heuzey@egp.aphp.fr | |
Unit | DÉPARTEMENT DE CARDIOLOGIE A, HÔPITAL EUROPÉEN GEORGES POMPIDOU, 20 RUE LEBLANC, 75908 PARIS CEDEX 15 |
Collaborations | |
Funding | |
Funding status |
Public |
Details | Ministère de la Santé (Soutien aux innovations diagnostiques et thérapeutiques coûteuses - STIC). |
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 |
Study databases |
Study databases (details) |
Longitudinal study (except cohorts) |
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 |
No |
Additional information regarding sample selection. | Prospective. Inclusion cut-off date: 01/06/2005. |
Database objective | |
Main objective | To assess the cost of automatic implantable defibrillator usage in France. Secondary objective: - Complications associated with automatic implantable defibrillators; - To investigate cause-specific mortality in patients with automatic implantable defibrillators; - The psychological impact of automatic implantable defibrillators; - Incidence of appropriate and inappropriate therapies. |
Inclusion criteria | All patients who received an automatic implantable defibrillator |
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 | 22 centres throughout France |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 06/2003 |
Date of last collection (YYYY or MM/YYYY) | 2005 |
Size of the database | |
Size of the database (number of individuals) |
[1000-10 000[ individuals |
Details of the number of individuals | 2418 |
Data | |
Database activity |
Data collection completed |
Type of data collected |
Declarative data |
Declarative data (detail) |
Paper self-questionnaire Face to face interview |
Presence of a biobank |
No |
Health parameters studied |
Health event/morbidity Health event/mortality |
Procedures | |
Data collection method | - Self-administered questionnaire: manual input from a paper questionnaire. - Interviews: input from a paper questionnaire. - Clinical examinations: handwritten. - Biological analysis: handwritten. |
Participant monitoring |
Yes |
Details on monitoring of participants | Every 2 years |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
Link to the document | http://tinyurl.com/Hal-EVADEF |
Description | List of publications in HAL |
Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=%28Marijon+E[author]+OR+Le+Heuzey+JY[author]%29+AND+evadef |
Description | List of publications in Pubmed |
Access | |
Terms of data access (charter for data provision, format of data, availability delay) | Data may not be used by academic teams |
Access to aggregated data |
Access on specific project only |
Access to individual data |
No access |
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