The Aortix CRS Pilot Study

The Aortix Crs Pilot Study: An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome

The study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and performance of the Aortix System in patients hospitalized with acute decompensated heart failure (ADHF) and worsening renal function refractory to medical management with persistent congestion. The Aortix system consists of the Aortix Delivery System, Introducer Set, the Aortix Pump, the Aortix Control System, and the Aortix Retrieval System.

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;

   1. 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