Alleviant ALLAY-HF Study is researching a new treatment for heart failure with preserved/mid-range ejection fraction (HFpEF/HFmrEF). This study uses a special device, the Alleviant ALV1 System, to create a small passage between the heart's chambers. This helps reduce pressure and improve symptoms. "Percutaneous" means the procedure is done through the skin, not open surgery. "NYHA Class" refers to how severe a person's heart failure symptoms are. To join, you need to have a certain level of heart function (LVEF ≥ 40%) and be on stable medication (GDMT).
- The study involves several visits to a medical center.
- Participants will be randomly assigned to either the actual procedure or a placebo (fake procedure).
- There are risks involved, such as those typical of heart procedures.