Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)

To be considered for this study, your heart care team at the local hospital would first need to decide that the EVOQUE treatment is the right option for you, based on its current guidelines for use. It's important that you understand and agree to attend all the planned follow-up appointments, which will happen over several years.

You would also need to provide your written consent, which means you've had all the information explained to you, you understand what taking part involves, and you agree to participate voluntarily. This consent form gives doctors permission to use your health information for the study.

You wouldn't be able to join if you're already taking part in another similar study that involves a new medical treatment, drug, or device and hasn't yet finished collecting its main results. Also, the study can't include people who are considered 'vulnerable populations,' which generally means individuals who might not be able to fully understand or freely agree to participate, such as very young children or those with certain mental health conditions.

If you decide to take part in this study, you would first have the EVOQUE system fitted. After the procedure, your health would be checked at several points. You would have appointments before the procedure, when you leave the hospital (or within 7 days), and then again after 30 days. Following this, you would have annual check-ups for five years.

These check-ups might involve various tests, such as heart scans or blood tests, and discussions with your doctor or nurse to see how you are feeling and how the treatment is working. The study expects to enroll new patients over about 2 to 4 years, and then everyone will be followed for up to 5 years after their procedure. This means your total involvement, from the time you receive the treatment to your last check-up, could be around five years.