The Aortix CRS Pilot Study

Inclusion Criteria: 1\) Admitted to the hospital with a primary diagnosis of acute decompensated heart failure, either heart failure with reduced or preserved ejection fraction (HFrEF, HFpEF or HFmEF); 2\) Worsening renal function (serum creatinine increase by ≥0.3 mg/dl \[≥27 μmol/L\]) despite 48 hours of intravenous diuretic therapy Increase can be compared to a baseline value taken within 90 days of hospitalization or during hospitalization; 3\) Objective measure of congestion (Elevated PCWP \[≥20 mmHg\] OR Elevated CVP \[≥12 mmHg\]) obtained via catheter measurement; 4\) Persistent clinical signs and/or symptoms of congestion despite diuretic therapy (one or more of the following): 1. dyspnea at rest or with minimal exertion, 2. paroxysmal nocturnal dyspnea, 3. orthopnea, 4. lower extremity edema (≥2+), 5. elevated jugular venous pressure, 6. pulmonary rales, 7. enlarged liver or ascites, 8. pulmonary vascular congestion on chest x-ray; 5\) Age \>21 years. \- Exclusion Criteria: 1\) Treatment with high dose IV inotropes within the last 48 hours. High dose is defined as \> 1 unit of inotrope (excluding digoxin) as follows: 5 µg/kg/min dopamine = 1 unit, 5 µg/kg/min dobutamine= 1 unit, 0.375 µg/kg/min milrinone = 1 unit, (for example, dopamine 2.5 µg/kg/min + dobutamine 2.5 µg/kg/min = 1 unit; dobutamine 2.5 µg/kg/min + milrinone 0.1875 µg/kg/min = 1 unit); 2\) Treatment with vasopressors to maintain blood pressure as per exclusion number 3; 3\) Active and ongoing hypotension defined as a systolic blood pressure \< 90 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \< 60 mmHg lasting more than 30 minutes; 4\) Acute Kidney Failure defined as increase in serum creatinine to ≥4.0 mg/dL (≥353.6 μmol/L) within the last 48 hours; 5\) Exposure to intravenous contrast, aminoglycosides or high dose NSAIDS in the 48 hours before enrollment; 6\) Known or suspected contrast induced nephropathy; 7\) Prior kidney transplant, isolated single kidney, stage V Chronic Kidney Disease (eGFR ≤15) at admission OR use of dialysis, continuous renal replacement therapy (CRRT) or aquapheresis (ultrafiltration) in last 90 days; 8\) Urologic intervention (except indwelling urinary (Foley) catheter)) within the last 7 days; 9\) Known cirrhosis or shock liver; 10\) Presence of an active infection; 11\) Prior heart transplant in the last 2 years, heart failure due to rejection of a previous heart transplant, planned heart transplantation before the 30-day follow-up visit; 12\) Current or previous support with a durable LVAD at any time or use of an intra-aortic balloon pump, extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g. Impella or TandemHeart) currently or within the last 30 days; 13\) Patient has known hypo- or hyper coaguable state such as disseminated intravascular coagulation or heparin induced thrombocytopenia (HIT); 14\) Known cardiac amyloidosis; 15\) Acute myocardial infarction Type 1 within 30 days of enrollment, or planned coronary revascularization; 16\) Stroke within 30 days of enrollment; 17\) Severe Bleeding Risk (any of the following): a) Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 7 days, b) GI bleeding within 6 months requiring hospitalization and/or transfusion, c) Recent major surgery within 6 months if the surgical wound is judged to be associated with an increased risk of bleeding, d) Endovascular procedure with ilio-femoral access \> 6 FR within 30 days, e) Platelet count \<75,000 cells/mm3, f) Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy); 18\) Current endovascular stent graft in the descending aorta or any femoro-iliac vessels; 19\) Contraindicated Anatomy: 1. Descending aortic anatomy that would prevent safe placement of the device \[\<18mm or \>31mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\], 2. Abnormalities of the aorta or iliac arteries that would prevent safe device placement, including aneurysms, significant tortuosity, or calcifications, 3. Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath including severe obstructive calcification or severe tortuosity, 4. Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury; 20\) Known hypersensitivity or contraindication to study or procedure medications (e.g. anticoagulation therapy) or device materials (e.g. history of severe reaction to nickel or nitinol); 21\) Positive pregnancy test if of childbearing potential; 22\) Participation in any other clinical investigation that is likely to confound study results or affect the study; 23\) Unable or unwilling to undergo screening (imaging, PA Catheter placement), device implant and retrieval procedures.