ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System

This study is looking for adults aged 18 or older who have heart failure. Specifically, you would likely be considered if your heart pumps blood quite well (meaning your left ventricle, the main pumping chamber, pushes out more than 40% of its blood with each beat), but you're still experiencing symptoms. You might have been in the hospital for heart failure recently, or needed changes to your diuretic medication (water pills).

You'd also need to show signs of fluid build-up in your lungs when you exercise, which doctors can measure with a special test. Importantly, your doctors would need to feel that you're already on the best available medications for your heart condition for at least 30 days and that these are likely to stay the same for a while.

However, you wouldn't be able to join if your heart failure is very severe (e.g., if you're on a heart transplant waiting list or need continuous medications to help your heart pump stronger). Also, if your heart previously pumped poorly and then improved, or if you have certain problems with your heart valves, you might not be eligible.

If you decide to take part, you would first go through some screening tests to confirm you're a good fit for the study. If you qualify, you would be randomly assigned to either receive the Edwards APTURE shunt system or a sham procedure. Both procedures involve a small cut in your groin to guide a tube to your heart, but only one group will have the device implanted.

After the procedure, you'll have several follow-up visits to check how you're doing. These visits will involve various tests and assessments to monitor your heart health, symptoms, and overall well-being. The research team will track your progress closely over time. You will continue to take your usual heart failure medications as prescribed by your doctor throughout the study.