Why was the database created?
This registry is used to carry out analyses to improve knowledge and care of severe valve disease not eligible for surgical treatment.
What data does the database contain?
- Population of interest
- Patients who have undergone a catheter-based procedure on the mitral or tricuspid valve.
- Main inclusion criteria
- - Patient aged over 18 at the time of the procedure, - With severe mitral or tricuspid valve disease, whatever its cause, - Symptomatic despite optimised medical treatment, - Judged not eligible for surgical correction of the valve following a multidisciplinary consultation meeting.
- 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 Treatments Clinical data
- Data collection methods
- eCRF
How is the data managed?
- Data retention period
- The data concerning each patient included in this registry will be kept for a period of 15 years from the date of inclusion.
Why is the database legal?
- Data controller
- Société Française de Cardiologie
- Legal basis
- The processing of data in this registry contributes to a task carried out in the public interest in the field of public health (Article 6(1)(e) and 9(2)(i) of the GDPR).
- Data quality and completion
- Clinical data are collected directly from patients by physicians or under their responsibility, providing a first level of quality. A consistency check of these data is carried out under the supervision of the SFC. SNDS data are updated annually. A data preparation pipeline is used to carry out data quality work, in particular to ensure their consistency.