An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure

This early feasibility study is testing a new device that creates a small opening between the heart's upper chambers (without leaving a permanent implant) to reduce fluid backup and pressure in patients with heart failure, potentially improving symptoms and reducing hospitalizations. **You may be eligible if...** - You have heart failure with reduced ejection fraction (heart pumps at 20–40% capacity) - You are in NYHA Class II–IV (moderate to severe heart failure symptoms) - You have had at least one hospitalization for heart failure, IV diuretics, or elevated BNP in the past year - You are already on maximum tolerated standard heart failure medications - Heart catheterization shows elevated filling pressures in the heart **You may NOT be eligible if...** - You have had a stroke, blood clot, or severe heart failure (non-ambulatory Class IV) in the past 6 months - You had a heart attack, cardiac surgery, or a cardiac device implanted in the past 3 months - Your heart is severely enlarged (LVEDD greater than 8 cm) or your cardiac output is very low - You are on a heart transplant list or have received inotropic drugs recently Talk to your doctor to see if this trial is right for you.