ITMO public health
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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