The Aortix CRS Pilot Study

Inclusion Criteria

• 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);
• 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;
• Objective measure of congestion (Elevated PCWP [≥20 mmHg] OR Elevated CVP [≥12 mmHg]) obtained via catheter measurement;
• Persistent clinical signs and/or symptoms of congestion despite diuretic therapy (one or more of the following):
• dyspnea at rest or with minimal exertion,
• paroxysmal nocturnal dyspnea,
• orthopnea,
• lower extremity edema (≥2+),
• elevated jugular venous pressure,
• pulmonary rales,
• enlarged liver or ascites,
• pulmonary vascular congestion on chest x-ray;
• Age >21 years.

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Exclusion Criteria

• 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);
• Treatment with vasopressors to maintain blood pressure as per exclusion number 3;
• Active and ongoing hypotension defined as a systolic blood pressure 6 FR within 30 days, e) Platelet count 31mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)],
• Abnormalities of the aorta or iliac arteries that would prevent safe device placement, including aneurysms, significant tortuosity, or calcifications,
• 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,
• Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury;
• 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);

• Positive pregnancy test if of childbearing potential;
• Participation in any other clinical investigation that is likely to confound study results or affect the study;
• Unable or unwilling to undergo screening (imaging, PA Catheter placement), device implant and retrieval procedures.