First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)

This study is looking for adults aged 18 or over who have been diagnosed with heart failure. To be considered, you should have experienced a worsening of your heart failure that required hospitalisation, treatment in a hospital day-care, or an urgent clinic visit within the last six months. It’s also important that your current heart failure treatment follows standard medical guidelines.

There are also some reasons why you might not be able to join. For example, if you have other serious health problems that might make it unsafe for you to take part, or if you have very poor kidney function. We also can't include people who have certain medical devices already implanted, or if you have specific issues with the large vein in your abdomen (the IVC) or in your legs.

We will also check if you have an implanted heart device that was put in very recently (within the last three months). If any of these apply to you, you might not be suitable for this particular study. The study team will discuss all these points with you to make sure it's the right fit.

If you decide to take part, you would first have a full health check to make sure the study is right for you. This would involve signing a consent form. While the exact details of what putting the device in will involve aren't fully described, you should expect it to be a medical procedure that will require some hospital time. After the device is put in, you will be followed very closely by the study team, especially for the first 3 months. During this time, they will monitor your health and check for any side effects or problems with the device. You will also have regular check-ups and assessments, which might involve clinic visits or other tests to track your progress. The study aims to follow you for a full 24 months to understand the long-term effects. The study team will provide you with a detailed schedule of visits and what to expect.