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.

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

• 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 [ ≥ 27μmol/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
• Age > 21 years and able to provide written informed consent

• Treatment with high dose IV inotropes within the last 48 hours
• Treatment with vasopressors to maintain blood pressure
• 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
• Acute Kidney Failure defined as increase in serum creatinine to ≥ 4.0 mg/dL ≥ 353.6 μmol/L) within the last 48 hours before enrollment
• Exposure to intravenous contrast, aminoglycosides or high dose NSAIDS in the 48 hours before enrollment
• Known or suspected contrast induced nephropathy
• 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
• Urologic intervention (except indwelling urinary (Foley) catheter)) within the last 7 days
• Known cirrhosis or shock liver
• Presence of an active infection
• Prior heart transplant in the last 2 years, heart failure due to rejection of a previous heart transplant, planned heart transplantation before 30 d follow-up visit
• 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
• Patient has known hypo- or hyper coaguable state such as disseminated intravascular coagulation or heparin induced thrombocytopenia (HIT)
• Known cardiac amyloidosis
• Acute myocardial infarction Type 1 within 30 days of enrollment, or planned coronary revascularization
• Stroke within 30 days of enrollment
• Severe bleeding risk
• Current endovascular stent graft in the descending aorta or any femoroiliac vessels

For additional information, please visit: https://clinicaltrials.gov/ct2/show/NCT04145635