Alleviate-HF-1 Study

Exclusion Criteria

• •1. Presence of advanced heart failure defined as one or more of the following:
• •* ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF.
• •* Cardiac index less than 2.0 L/min/m2.
• •* Patient is on the cardiac transplant waiting list.
• •* Inotropic infusion (continuous or intermittent) for EF less than 40% within the past 6 months.
• •2. Presence of moderate or worse valve disease, defined as one or more of the following:
• •* Moderate or worse mitral valve regurgitation or moderate or worse mitral stenosis.
• •* Moderate or worse tricuspid valve regurgitation.
• •* Moderate or worse aortic valve disease defined as moderate or worse AS or AI.
• •3. . Presence of chronic pulmonary disease defined by one or more of the following:
• •* Requirement for continuous home oxygen use.
• •* Hospitalization within the past 12 months for treatment of pulmonary disease.
• •* Significant chronic pulmonary disease defined as FEV1 less than 50%.
• •4. Documented as currently requiring dialysis or estimated GFR less than 25ml/min/1.73m2
• •5. 6-minute walk distance less than 50 m or greater than 450 m performed during screening.
• •6. Documented atrial fibrillation with ventricular rate greater than 100 BPM at screening.
• •7. Presence of moderate or worse right heart dysfunction OR RV dysfunction defined as TAPSE less than 14 mm or RVFAC less than or equal to 30%
• •8. Presence of pulmonary hypertension with PASP greater than or equal to 70 mmHg OR PVR greater than 4 Wood units.
• •9. Presence of anatomic anomaly that precludes creation of interatrial shunt (including patent foramen ovale, atrial septal defect, target septal thickness greater than 3 mm)
• •10. SBP greater than 170 mmHg at screening.
• •11. Documented left ventricular end diastolic diameter greater than 6 cm.