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