The Aortix CRS Pilot Study

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.

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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.