Overview

Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy.

Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management.

Eligibility

Inclusion Criteria (Randomized Study):

• Currently admitted to the hospital with a primary diagnosis of decompensated heart failure, irrespective of ejection fraction (EF);
• Following at least 48 hours of the higher of: i) furosemide 80 mg IV bid or equivalent or ii) IV furosemide or equivalent IV loop diuretic at a dose 2.5 x total daily home dose of furosemide equivalents in 2 divided doses, as tolerated, patient must have: Urine Output <1,500mL in a 12-hour period OR a Net Fluid Loss ≤375mL in a 12-hour period.
• Persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure >12 cm water or ascites after treatment with IV diuretics per inclusion criterion 2.;
• Age >21 years and able to provide written informed consent;
• Negative pregnancy test if patient is of child-bearing potential.

Exclusion Criteria (Randomized Study):

• Treatment with high dose IV inotropes within the last 48 hours prior to enrollment. High dose is defined as >5 µg/kg/min dopamine OR >5 µg/kg/min dobutamine OR >0.375 µg/kg/min milrinone;
• Active and ongoing hypotension with a systolic blood pressure <90 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) <60 mmHg lasting more than 30 minutes at enrollment;
• Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment;
• An estimated PASP of >80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure;
• Treatment with IV diuretics (does not have to be continuous) for ≥21 days during the current hospitalization (including time spent at an outside hospital);
• Acute kidney failure defined as an increase in serum creatinine to ≥4.0mg/dL (≥353.6 µmol/L) at enrollment;
• Evidence of contrast induced nephropathy, nephritis or nephrotic syndrome;
• Prior kidney transplant, single kidney, partial nephrectomy, stage V chronic kidney disease (eGFR <18) at enrollment OR use of dialysis, continuous renal replacement therapy (CRRT) or ultrafiltration in the last 90 days prior to enrollment;
• Confirmed decompensated cirrhosis (defined as Child Pugh class B or C) or concern for shock liver (AST > 1000U/L or total Bilirubin > 5.0mg/dl) at enrollment;
• Presence of an active, uncontrolled infection that would preclude safe placement or removal of the device;
• Prior heart transplant or likely heart transplantation before the 30- day follow-up visit;
• Current or previous support with a durable LVAD at any time or planned LVAD insertion before the 30-day follow-up visit;
• Use of an intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g. Impella or TandemHeart) within the last 30 days;
• Known amyloidosis of any type;
• Acute myocardial infarction Type 1 within 30 days of enrollment, or planned coronary revascularization in the next 30 days;
• Stroke within 30 days of enrollment;
• Severe Bleeding Risk (any of the following):
  1. 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,
  2. GI bleeding within 6 months requiring hospitalization and/or transfusion,
  3. Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding,
  4. Procedure with arterial ilio-femoral access > 6 FR within 30 days,
  5. Platelet count <75,000 cells/mm3,
  6. Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy) or hypercoaguable state including HIT;
  7. Inability to tolerate anticoagulation therapy for up to 7 days.
• Contraindicated Anatomy :
  1. Descending aortic anatomy that would prevent safe placement of the device [<18 mm or >31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)],
  2. Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath,
  3. Femoral artery depth inconsistent with use of closure device,
  4. Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g. aneurysm with thrombus, marked tortuosity, significant narrowing or inadequate size of the abdominal aorta, iliac or femoral arteries, or severe calcification),
  5. Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury,
  6. Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction/removal of the Aortix pump as demonstrated by imaging.
• 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);

• Participation in any other clinical investigation that is likely to confound study results or affect the study;
• Poor health such that the patient is unable to undergo the Aortix device placement/retrieval and/or unlikely to be able to survive to the 30-day visit;
• Unable or unwilling to undergo screening (imaging, PA Catheter placement), device implant and retrieval procedures or return for 30-day visit.