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

Prior treatment

• 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.
• Chronic pulmonary disease requiring continuous home oxygen or hospitalization within the prior 12 months for pulmonary disease.

Other illness

• Transseptal procedure or percutaneous cardiac intervention planned within the next 6 months.

Lab values

• 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%.

Other

• Patent foramen ovale (PFO) device or atrial septal defect (ASD) device.
• BMI \> 40.
• Anatomic anomaly that precludes creation of interatrial shunt.

• 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.