J-Valve Transfemoral Pivotal Study

This study is looking for adults aged 18 and over who have been diagnosed with severe leaking of their aortic valve (aortic regurgitation or AR). You would need to be experiencing symptoms such as breathlessness or fatigue due to your heart condition. Very importantly, a team of heart specialists must have decided that open-heart surgery to replace your valve would be too risky for you.

Your heart valve problem needs to be clearly identified as severe AR through detailed scans. Also, your heart's structure must be suitable for the J-Valve TF System to be put in safely. You'd also need to be able to give your informed consent, meaning you understand the study and agree to take part, including attending all follow-up appointments.

There are also reasons why you might not be able to join the study. For example, if you've already had an artificial aortic valve fitted, or if you have other serious heart valve problems that are equally severe. Certain other serious health conditions, like active infections, severe kidney or liver disease, or certain blood disorders, would also prevent you from participating in this study.

If you join this study, you will receive the J-Valve TF System implant. Before the procedure, you'll undergo thorough health checks and scans to ensure it's suitable for you. After the procedure, you will have regular follow-up appointments and various assessments for up to five years. These appointments will involve checking your general health, heart function, and how you are feeling. You will also need to take specific medicines, such as blood thinners, as prescribed by the study doctors. The total duration of your participation will be five years from the date of your implant procedure.