The Aortix CRS Pilot Study

Completed · Not applicable

Conditions studied: Heart Failure; With Decompensation, Cardiorenal Syndrome, Cardio-Renal Syndrome, Heart Failure, Heart Failure，Congestive, Heart Failure, Systolic, Heart Failure, Diastolic

In brief

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

Key facts

Study ID

NCT04145635

Run by

Procyrion

People needed

21

Starts

2021-02-05

Expected to finish

2023-03-09

Last updated by the study team

2024-04-17

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 < 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;
• 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 the 30-day 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 (any of the following):
• a) 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, 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);
• Current endovascular stent graft in the descending aorta or any femoro-iliac vessels;
• Contraindicated Anatomy:
• 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)],
• 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.

Where it is running

• University of Southern California — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Colorado — Denver, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Columbia University/New York Presbyterian — New York, New York, United States
• Christ Hospital — Cincinnati, Ohio, United States
• Houston Methodist — Houston, Texas, United States
• Inova Health Care Services — Falls Church, Virginia, United States
• Sentara Hospital — Norfolk, Virginia, United States
• St. Vincent's Hospital — Sydney, New South Wales, Australia
• Prince Charles Hospital — Brisbane, Queensland, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Western Health, Footscray Hospital — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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