Aortix Therapy for Perioperative Reduction of Kidney Injury

Study Overview
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Brief Summary
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The study is a prospective, non-randomized feasibility study to evaluate the safety and performance of providing support with the Aortix System to patients at heightened risk of acute kidney injury (AKI) undergoing cardiovascular surgery.

Detailed Description
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The study is a prospective, non-randomized feasibility study to evaluate the safety and performance of providing support with the Aortix System to patients at heightened risk of acute kidney injury (AKI) undergoing cardiovascular surgery. Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant will be followed in a the non-Aortix arm. Both arms will have the same visit schedule and data collection requirements with the exception of data pertaining to the Aortix system. Data will be reported for both groups.

Official Title
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Aortix Therapy for Perioperative Reduction of Kidney Injury

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Device: Aortix System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have the following risk factor(s) for AKI prior to surgery: Estimated glomerular filtration rate (eGFR) of ≥ 15 and < 30 ml/min/1.73m2, OR eGFR ≥ 30 and < 60 ml/min/1.73m2 and ONE or more of the following: Diabetes (regardless of cause) with metabolic, renal, ophthalmic, neurologic, circulatory, or other complications Documented NYHA class III or IV heart failure within 1 year prior to enrollment Left ventricular ejection fraction < 35% Hypertension with comorbid heart or kidney disease Persistent Atrial Fibrillation Planned (non-emergency) cardiac surgical procedure including, but not limited to coronary bypass surgery, surgical valve replacement or valve repair Age >21 years, willing and able to provide written informed consent. - Exclusion Criteria: An eGFR of <15 ml/min/1.73m2 at enrollment Cardiac surgical procedure that uses femoral artery cannulation for cardiopulmonary bypass Current support with a durable LVAD, intra-aortic balloon pump, extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g., Impella or TandemHeart) Patient has known hypo- or hyper-coagulable state such as disseminated intravascular coagulation or heparin induced thrombocytopenia (HIT) Endovascular procedure with ilio-femoral access >12F within previous 30 days Severe Bleeding Risk (any of the following): Previous intracranial bleed such that the patient cannot safely use anticoagulation per the study requirements Platelet count <75,000 cells/mm3 Uncorrectable bleeding diathesis or coagulopathy (e.g., INR ≥ 2 not due to anticoagulation therapy Current endovascular stent graft in the descending aorta or either ilio-femoral vessels Contraindicated Anatomy: Descending aortic anatomy that would prevent safe placement of the device [<18 mm or >31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)] Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g., aneurysm with thrombus; marked tortuosity; significant narrowing or inadequate size of the abdominal aorta, iliac, or femoral arteries; or severe calcification) Known connective tissue disorder (e.g., Marfan Syndrome) or other aortopathy at risk of vascular injury Known hypersensitivity or contraindication to study required 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 -

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Aortix System|Aortix is indicated as a partial circulatory support device to increase renal perfusion and reduce the incidence of acute kidney injury (AKI) in patients undergoing cardiac surgery who are at heightened risk of developing AKI.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Report the rate of Occurrence of Serious Adverse Events related to the Aortix therapy | Enrollment to 30 days post-surgery | 
| Effectiveness | Characterize the incidence of AKI observed up to 72 hours post-surgery using the KDIGO criteria | baseline to 72 hours post-surgery | 
| Effectiveness | Characterize the rate of postoperative use of renal replacement therapy (RRT), ultrafiltration and/or dialysis | Aortix placement to 30 days post- surgery | 
| Effectiveness | Characterize the rate of 30-day post-surgery readmission due to worsening renal function | If discharged by day 30 post-surgery |