The Aortix CRS Pilot Study
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;

 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 within the past 7 days;

 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 7 days;

 5) Exposure to intravenous contrast, aminoglycosides or high dose NSAIDS in the 7 days
 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 and/or current treatment with intravenous
 antibiotics;

 11) Prior heart transplant, listed or planned listing for heart transplantation;

 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, cardiac sarcoidosis or Chagas disease;

 15) Acute myocardial infarction Type 1 within 30 days of enrollment, or planned
 coronary revascularization;

 16) Stroke within 30 days;

 17) Severe Bleeding Risk (any of the following):

 a) Previous intracranial bleed at any time, 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 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.