Why was the database created?
Creation of a database of patients suffering from refractory stable angina of class 3 or 4 treated by implantation of the NEOVASC REDUCER medical device, in order to conduct research into this condition, and to obtain real-world data, notably for the purpose of obtaining long-term reimbursement of the device.
What data does the database contain?
- Population of interest
- Patients suffering from refractory angina treated by implantation of the coronary sinus reducer system NEOVASC REDUCER
- Main inclusion criteria
- Patient suffering from refractory stable angina of class 3 or 4 Patients treated by implantation of the NEOVASC REDUCER medical device
- Age group
- Older adult (65 and over) Adult (18 to 64)
- Data category
- Medical and administrative data Treatments Clinical data
- Data collection methods
- eCRF
How is the data managed?
- Data retention period
- 10 years from inclusion
Why is the database legal?
- Data controller
- SFC
- Legal basis
- The warehouse is set up as part of a task carried out in the public interest in the field of public health, and is based on patients' consent
- Data transfer outside the EU
- None