Cardiovascular Research Institute of Kansas, LLC | Wichita, KS
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Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy.
Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management.
Full description
The study is a prospective, multi-center, randomized, nonblinded study to evaluate the safety and effectiveness of the Aortix System versus standard of care medical therapy in patients hospitalized with acute decompensated heart failure (ADHF) and persistent congestion despite usual medical management.Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management. Randomization will be stratified by ejection fraction..
An additional registry arm will enroll patients who are considered candidates for advanced therapies in the near-term, but need improvement in their renal function to be able to receive additional medical therapies. All eligible enrolled registry subjects will receive Aortix system support.
Planned study population is male or female patients 21 years of age or greater, with acute decompensated heart failure and diuretic resistance who remain congested despite standard of care medical therapy.
This study will enroll up to 268 subjects with heart failure at 45 clinical sites in the United States. The randomized study includes up to 188 subjects and the Advanced HF registry includes up to 80 subjects.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria (Randomized Study):
Exclusion Criteria (Randomized Study):
Treatment with high dose IV inotropes within the last 48 hours prior to enrollment. High dose is defined as >5 µg/kg/min dopamine OR >5 µg/kg/min dobutamine OR >0.375 µg/kg/min milrinone;
Active and ongoing hypotension with a systolic blood pressure <90 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) <60 mmHg lasting more than 30 minutes at enrollment;
Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment;
An estimated PASP of >80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure;
Treatment with IV diuretics (does not have to be continuous) for ≥21 days during the current hospitalization (including time spent at an outside hospital);
Acute kidney failure defined as an increase in serum creatinine to ≥4.0mg/dL (≥353.6 µmol/L) at enrollment;
Evidence of contrast induced nephropathy, nephritis or nephrotic syndrome;
Prior kidney transplant, single kidney, partial nephrectomy, stage V chronic kidney disease (eGFR <18) at enrollment OR use of dialysis, continuous renal replacement therapy (CRRT) or ultrafiltration in the last 90 days prior to enrollment;
Confirmed decompensated cirrhosis (defined as Child Pugh class B or C) or concern for shock liver (AST > 1000U/L or total Bilirubin > 5.0mg/dl) at enrollment;
Presence of an active, uncontrolled infection that would preclude safe placement or removal of the device;
Prior heart transplant or likely heart transplantation before the 30- day follow-up visit;
Current or previous support with a durable LVAD at any time or planned LVAD insertion before the 30-day follow-up visit;
Use of an intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g. Impella or TandemHeart) within the last 30 days;
Known amyloidosis of any type;
Acute myocardial infarction Type 1 within 30 days of enrollment, or planned coronary revascularization in the next 30 days;
Stroke within 30 days of enrollment;
Severe Bleeding Risk (any of the following):
Contraindicated Anatomy :
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);
Participation in any other clinical investigation that is likely to confound study results or affect the study;
Poor health such that the patient is unable to undergo the Aortix device placement/retrieval and/or unlikely to be able to survive to the 30-day visit;
Unable or unwilling to undergo screening (imaging, PA Catheter placement), device implant and retrieval procedures or return for 30-day visit.
Primary purpose
Allocation
Interventional model
Masking
268 participants in 3 patient groups
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Central trial contact
Rubi Reyes-Fuentez
Data sourced from clinicaltrials.gov
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