Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

Inclusion Criteria:

• Symptomatic Heart Failure (HF):

• NYHA class II with a history of > II; III; or ambulatory IV AND

• ≥ 1 HF hospital admission; or treatment with IV or oral diuresis within 12months; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinusrhythm, > 150 pg./ml in atrial fibrillation within the past 6 months prior tostudy entry.

• On stable Guideline Directed Medical Therapy (GDMT) for heart failure

• At rest: elevated LAP (or PCWP) of > 15 mmHg and LAP (or PCWP) exceeds right atrialpressure (RAP) by > 5 mmHg AND/OR supine ergometer exercise, elevated LA (or PCWP)pressure of > 25 mmHg and LA (or PCWP) exceeds right atrial pressure (RAP) by > 10mmHg

• Left Ventricular Ejection Fraction (LVEF) ≤ 40%

• Pulmonary Vascular Resistance (PVR) < 4.0 WU

Exclusion Criteria:

• Severe HF:

• Stage D, non-ambulatory NYHA Class IV, transplant list

• If BMI < 30, Cardiac index < 2.0 L/min/m2

• If BMI ≥ 30, cardiac index < 1.8 L/min/m2

• Left Ventricular End-Diastolic Diameter (LVEDD) > 8 cm

• LVEF < 20%

• Valve disease: MR > 3+ or > moderate MS, TR > 2+, AR > 2+ or > moderate AS

• MI or therapeutic invasive cardiac procedure < 3 months

• TIA, stroke, CRT implanted < 6 months

• RV dysfunction > mild by TTE OR TAPSE < 1.2 OR RV size ≥ LV size by TTE, OR rightventricular fractional area change (RVFAC) ≤ 25%

• Dialysis OR renal dysfunction (S-CR > 2.5 mg/dl OR eGFR < 25 ml/min/1.73m2)

• 6MWT < 50m OR > 600m

• Active endocarditis or infection < 3 months

• Mean Right Atrial Pressure (mRAP) > 15 mmHg at rest

• Body Mass Index (BMI) ≥ 45 kg/m2