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

Inclusion Criteria: * NYHA Class II at screening with a prior history of greater than NYHA Class II, OR NYHA Class III at screening, OR ambulatory Class IV at screening: with documented medical history of heart failure for at least 6 months prior to the screening visit. * At least one hospitalization for heart failure OR treatment with IV diuretics for heart failure OR elevated BNP in the prior 12 months. * Receiving maximally tolerated guideline directed medical therapy for Heart Failure management. * LVEF ≥ 20% and ≤ 40% according to baseline echocardiography. * Resting right heart catheterization demonstrates elevated PCWP compared to right atrial pressure. Exclusion Criteria: * Any of the following within the prior 6 months: Stroke, thromboembolism, severe or advanced heart failure such as Stage D heart failure, non-ambulatory NYHA Class IV, cardiac index less than 1.8 L/min/m2, LVEDD \> 8 cm, or received inotropic therapy for LVEF less than 20%. * Any of the following within the prior 3 months: Myocardial infarction percutaneous cardiac intervention, CABG, on cardiac transplant list, cardiac resynchronization therapy implant, AICD implant, or indicated for coronary revascularization at the time of enrollment. * Transseptal procedure or percutaneous cardiac intervention planned within the next 6 months. * Chronic pulmonary disease requiring continuous home oxygen or hospitalization within the prior 12 months for pulmonary disease. * Patent foramen ovale (PFO) device or…