Reducing Lung CongestIon Symptoms in Advanced Heart Failure

Main Inclusion Criteria:

   - Both heart failure with reduced ejection fraction (HFrEF) and heart failure with
   preserved ejection fraction (HFpEF) patients

   - NYHA Class II, Class III, or ambulatory Class IV HF

   - Receiving guideline directed medical and device therapy (GDMT) for heart failure

   - For NYHA Class III and ambulatory Class IV, at least one prior hospitalization for
   heart failure within the last year or elevated BNP level of at least 300 pg/ml or
   NT-proBNP level of at least 1,500 pg/ml. BNP/NT-ProBNP levels corrected for BMI

   - For NYHA Class II, must have both hospitalization and elevated BNP levels as above
   specifications

Main Exclusion Criteria:

   - Systolic blood pressure <90 or >160 mmHg

   - Presence of Intracardiac thrombus

   - Pulmonary hypertension with PASP of ≥70 mm/Hg or PVR > 4 WU

   - Significant RV dysfunction - TAPSE <12mm or RVFAC ≤25%

   - Left Ventricular End-Diastolic Diameter (LVEDD) >8cm

   - Moderate to severe aortic or mitral stenosis

   - Stroke or TIA or DVT within the last 6 months

   - eGFR <25 ml/min/1.73 m^2

   - Anatomical anomaly on TEE or ICE that precludes implantation of Shunt across fossa
   ovalis (FO) of the interatrial septum

   - Inadequate vascular access for implantation of shunt, e.g. femoral venous access for
   transseptal catheterization and inferior vena cava (IVC) is not patent

   - Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion
   Criteria