Hemodynamic-GUIDEd Management of Heart Failure

• Diagnosis and treatment for heart failure (HF) (regardless of left ventricular ejection fraction (LVEF)) for \> 90 days prior to the date of consent:

• a. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.

• GUIDE-HF Randomized Arm Only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent.

• GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent.

• HF hospitalization (HFH) within 12 months prior to consent and/or elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) within 30 days prior to consent defined as:

‣ Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).

⁃ Thresholds for NT-proBNP and BNP (for both LVEF ≤ 40% and LVEF \> 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2

• ≥ 18 years of age

• Chest circumference of \< 65 inches, if BMI is \> 35 kg/m2

• Written informed consent obtained from subject

• Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements