Testing a device that stimulates the diaphragm to improve heart failure

This trial is testing a new device called the VisONE System that uses synchronized diaphragmatic stimulation (SDS) to help improve heart function in people with heart failure. The device is surgically implanted and works by gently stimulating the diaphragm—the main breathing muscle—in sync with your heartbeat to reduce the pressure inside your heart and improve how well it pumps. You would continue taking all your regular heart failure medications alongside this new treatment.

Heart failure causes the heart to pump less efficiently, which raises pressure inside the heart and makes it harder to exercise and feel well. Current medications help, but doctors are looking for additional ways to reduce these pressures and improve symptoms. This trial is testing whether stimulating the diaphragm at just the right moment in the heartbeat cycle could provide extra benefit.