France TAVI

What data does the database contain?

Population of interest

Patients who have undergone aortic valve bioprosthesis implantation via a trans-arterial or trans-apical approach in one of the participating healthcare facilities.

Age group

Older adult (65 and over) Adult (18 to 64)

Data category

Identification data (not directly identifying) Medical and administrative data Directly identifying data Quality of life Socio-professional data Clinical data

Data collection methods

eCRF

How is the data managed?

Data retention period

The data will be kept until 2025 for analysis as part of research projects, and will then be archived for a period of 10 years.

Why is the database legal?

Data controller

Société Française de Cardiologie

Legal basis

The processing carried out by the SFC is necessary for the performance of the task carried out in the public interest with which it is entrusted. This processing is therefore lawful under Article 6-1-e) of the GDPR and meets a condition allowing the processing of data concerning health under Article 9-2-i) of the GDPR.

Data quality and completion

Clinical data are collected directly from patients by physicians or under their supervision, ensuring a first level of quality. A consistency check of these data is carried out under the supervision of the SFC. SNDS data are updated on an annual basis. A data preparation pipeline is used to perform data quality work, including in particular ensuring their consistency.

Data transfer outside the EU

The data are collected through an observation logbook hosted by IBM Cloud. These data are processed within the European Union. Maintenance operations on this platform are carried out by IBM teams located in the European Union. In exceptional cases where the European teams are unable to resolve a technical issue, access may be granted to IBM teams located outside the European Union solely for the purposes of this maintenance. In such a situation, IBM undertakes to comply with data protection rules equivalent to European regulations, in accordance with the standard contractual clauses issued by the European Commission.

Data sources feeding France TAVI

Research projects powered by France TAVI