ITMO public health
Last update : 01/13/2019 | Version : 1 | ID : 73038
| General | |
| Identification | |
| Detailed name | Cohort of Patients Who Underwent Aortic Valve Replacement with Bioprosthesis |
| Sign or acronym | CordaBASE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL: 910300 |
| General Aspects | |
| Medical area |
Cardiology |
| Health determinants |
Healthcare system and access to health care services Iatrogenic |
| Keywords | valve deterioration, cardiology, thoracic surgery, prosthesis, aortic valve bioprosthesis, Mitroflow, cardiovascular |
| Scientific investigator(s) (Contact) | |
| Name of the director | Roussel |
| Surname | Jean-Christian |
| Phone | +33 (0)2 40 16 50 84 |
| jeanchristian.roussel@chu-nantes.fr | |
| Organization | Nantes University Hospital |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | Nantes University Hospital Thorax Institute |
| Funding | |
| Funding status |
Public |
| Details | Nantes university Hospital |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Nantes |
| 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 is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
Yes |
| Details |
Performed at individual level |
| Database objective | |
| Main objective |
To provide specific information (incidence, mechanism, impact) regarding structural valve deterioration after fitting a Mitroflow valve.
To compare the results with other bioprosthesis. To provide clinicians with information in order to choose the best solution for fitting a valve in the event of heart valve disease. |
| Inclusion criteria | Patients who underwent consecutive operations for heart valve replacement with a bioprosthesis (SORIN Mitroflow® or Carpentier-Edwards Perimount®) within the Cardiac Surgery Department at Nantes University Hospital. |
| 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 |
| Pathology | IX - Diseases of the circulatory system |
| Gender |
Male Woman |
| Geography area |
Local |
| French regions covered by the database |
Pays de la Loire |
| Detail of the geography area | Nantes |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2002 |
| Date of last collection (YYYY or MM/YYYY) | 2019 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | Sorin Mitroflow, Carpentier-Edwards Perimount 2900, Cardpentier Edwards Magna Ease, St-Jude Trifecta, Medtronic Mosaic |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | Surgical assessment; surgical procedure; stay in ICU; progression within the department |
| Paraclinical data (detail) | Ultrasound |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization |
| Procedures | |
| Data collection method | By medical staff during hospital stay then during routine visits following surgery. |
| Participant monitoring |
Yes |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | List of patient deaths and ultrasounds carried out in the city. |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/PUBMED-CordaBase |
| 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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