An implanted device (Edwards APTURE transcatheter shunt system) for symptomatic heart failure

You may qualify if

• 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:; 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