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8110 Gatehouse Road, Falls Church, VA 22042

The Aortix™ CRS Pilot Study

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General Information

Age Group

Adults

Status

Active

Protocol Number

NCT04145635

Background Information

An evaluation of the safety and performance of the aortix system for intra-aortic mechanical circulatory support in patients with cardiorenal syndrome.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Shashank Sinha, MD and Behnam Tehrani, MD

Eligibility Information

  • 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

Ineligibility Information

  • 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