Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

For people ages 18 years and up

Refined HFrEF Subgroup Inclusion Criteria:

• A primary diagnosis of HFrEF (LVEF ≤ 40%), and
• NYHA Class II, III, or IVa heart failure symptoms and
• Documentation of at least one of the following in the past 12 months, such as:
  • Hospitalization for heart failure; or
  • Increased treatment for heart failure, including intravenous (IV) or higher-dose diuretic therapy.
  • Elevated heart failure biomarker levels (BNP or NT-proBNP) within the past 6 months.

Note: Participants with NYHA Class II symptoms must have both a recent heart failure worsening event and elevated biomarker levels. Participants with NYHA Class III or IVa symptoms must have either a recent heart failure worsening event or elevated biomarker levels.

• Stable Optimized GDMT - Maintained 6 months post-implant (includes stable GLP-1 RA)

Refined HFrEF Subgroup Exclusion Criteria:

• Severe HF defined as one or more of the following:
  • Ambulatory NT-proBNP value >5,000 pg/ml or BNP value >1,600 pg/ml
  • Left ventricular end-diastolic diameter (LVEDD) >8 cm
  • Left ventricular ejection fraction (LVEF) < 20%
  • ACC/AHA Stage D HF or non-ambulatory NYHA Class IV HF
  • Inotropic infusion (continuous or intermittent) within the past 6 months
  • Active listing on the cardiac transplant waiting list
• More than mild right ventricular dysfunction
• Valve disease
  • Mitral regurgitation > moderate
  • Mitral stenosis > mild
  • Tricuspid regurgitation > moderate
  • Aortic regurgitation > moderate
  • Aortic stenosis > moderate
• Body mass index (BMI) ≥45
• Myocardial infarction and/or any therapeutic invasive, non-valvular cardiac procedure within the past 3 months, or current indication for coronary revascularization
• Stroke, transient ischemic attack, deep vein thrombosis, or pulmonary embolus within the past 6 months
• Cardiac resynchronization therapy implanted within the past 12 months
• Renal insufficiency as determined by serum creatinine (sCr) level >2.5 mg/dL or estimated glomerular filtration rate (eGFR) <25 ml/min/1.73 m2
• Performance of the 6-minute walk test with a distance <100 m or >450 m
• Active endocarditis or infection requiring intravenous antibiotics within 3 months of scheduled index procedure
• Presence of one or more of the following resting hemodynamic findings:
  1. Mean pulmonary capillary wedge pressure (PCWP) >35 mmHg
  2. Mean right atrial pressure (RAP) >15 mmHg
  3. Mean PCWP-mean RAP gradient < 5 mmHg
  4. Pulmonary vascular resistance (PVR) ≥5 Wood Units (WU)
  5. Cardiac index <1.8 L/min/m2