The Aortix CRS Pilot Study

Study Overview
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Brief Summary
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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

Detailed Description
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The study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and performance of the Aortix System in patients hospitalized with acute decompensated heart failure (ADHF) and worsening renal function refractory to medical management with persistent congestion. The Aortix system consists of the Aortix Delivery System, Introducer Set, the Aortix Pump, the Aortix Control System, and the Aortix Retrieval System.

Official Title
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An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients With Cardiorenal Syndrome

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

Intervention / Treatment
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* Device: Aortix System


Participation Criteria
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Eligibility Criteria
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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. - 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.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aortix Device<br>Aortix Pump, Aortix Delivery System, Introducer Set, Aortix Control System, Aortix Retrieval System | Device: Aortix System<br>* Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) with worsening renal function.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | Rate of Occurrence of Serious Adverse Events (rate will be calculated and reported) | 30 days | 
| Serious Procedure Related Adverse Events | Rate of Occurrence of Serious Procedure Related Adverse Events (rate will be calculated and reported) | 30 days | 
| Device Performance | Deployment and retrieval procedures success rates (rates will be calculated and reported) | 7 days | 
| Device Performance | Rate of occurrence of ADS, ARS and pump device-related adverse events (includes device malfunctions) (rate will be calculated and reported) | 30 days | 
| Effectiveness | Clinically significant decongestion as measured by the PA catheter. Decrease in CVP or PCWP of > 20%. | 7 days | 
| Urine Output | Change in Urine Output Assessed as the hourly rate of urine output before pump placed vs hourly rate of urine output over the Aortix therapy period (until congestion target met or therapy deemed ineffective) | 7 days | 
| BNP (Brain natriuretic peptide) | Decrease in BNP or NT-pro-BNP by 20% (pre-implant vs when congestion target is met or therapy deemed ineffective) | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical circulatory support, percutaneous