Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

The early feasibility study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial 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 12 months; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months prior to study 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 atrial pressure (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 > 10 mmHg
• 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 right ventricular 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