The Aortix CRS Pilot Study
Heart Failure; With Decompensation, Cardiorenal Syndrome, Cardio-Renal Syndrome
About this trial
This is an interventional treatment trial for Heart Failure; With Decompensation focused on measuring mechanical circulatory support, percutaneous
Eligibility Criteria
Inclusion Criteria:
1) 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);
2) 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;
3) Objective measure of congestion (Elevated PCWP [≥20 mmHg] OR Elevated CVP [≥12 mmHg]) obtained via catheter measurement;
4) 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;
5) Age >21 years.
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Exclusion Criteria:
1) 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);
2) Treatment with vasopressors to maintain blood pressure as per exclusion number 3;
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;
4) Acute Kidney Failure defined as increase in serum creatinine to ≥4.0 mg/dL (≥353.6 μmol/L) within the last 48 hours;
5) Exposure to intravenous contrast, aminoglycosides or high dose NSAIDS in the 48 hours before enrollment;
6) Known or suspected contrast induced nephropathy;
7) 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;
8) Urologic intervention (except indwelling urinary (Foley) catheter)) within the last 7 days;
9) Known cirrhosis or shock liver;
10) Presence of an active infection;
11) 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;
12) 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;
13) Patient has known hypo- or hyper coaguable state such as disseminated intravascular coagulation or heparin induced thrombocytopenia (HIT);
14) Known cardiac amyloidosis;
15) Acute myocardial infarction Type 1 within 30 days of enrollment, or planned coronary revascularization;
16) Stroke within 30 days of enrollment;
17) 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);
18) Current endovascular stent graft in the descending aorta or any femoro-iliac vessels;
19) 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;
20) 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);
21) Positive pregnancy test if of childbearing potential;
22) Participation in any other clinical investigation that is likely to confound study results or affect the study;
23) Unable or unwilling to undergo screening (imaging, PA Catheter placement), device implant and retrieval procedures.
Sites / Locations
- University of Southern California
- University of California, San Francisco
- University of Colorado
- University of Florida
- University of South Florida
- Cleveland Clinic Florida
- University of Chicago
- University of Michigan
- Henry Ford Health System
- Columbia University/New York Presbyterian
- Christ Hospital
- Houston Methodist
- Inova Health Care Services
- Sentara Hospital
- St. Vincent's Hospital
- Prince Charles Hospital
- Royal Adelaide Hospital
- The Alfred Hospital
- Western Health, Footscray Hospital
Arms of the Study
Arm 1
Experimental
Aortix Device
Aortix Pump, Aortix Delivery System, Introducer Set, Aortix Control System, Aortix Retrieval System