Early Feasibility Study of the Edwards APTURE Transcatheter Shunt System

Criteria the registry did not label

• 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), indicated device therapy, and comorbidity management.
  • 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, or unmet guideline-directed indication for CRT
• 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:
  • Mean pulmonary capillary wedge pressure (PCWP) \>35 mmHg
  • Mean right atrial pressure (RAP) \>15 mmHg
  • Mean PCWP-mean RAP gradient \< 5 mmHg
  • Pulmonary vascular resistance (PVR) ≥5 Wood Units (WU)
  • Cardiac index \<1.8 L/min/m2
• Baseline resting heart rate \>100 bpm