Aortix Device for Acute Heart Failure
This study is looking at a device called the Aortix System for people hospitalized with acute heart failure (when your heart can't pump enough blood to meet your body's needs) and who aren't responding well to diuretics (water pills). You might be able to join if you are 21 or older, have heart failure, and your body isn't getting rid of enough fluid with your current diuretic treatment. The study wants to see if the Aortix System is safe and effective compared to standard medical care. Success would mean fewer serious problems related to the device and a good combination of fluid loss, staying alive, and not needing to be re-hospitalized for heart failure or have your treatment increased within 30 days.
- Study design
- This study is a randomized, nonblinded study with up to 320 participants. Participants will either receive the Aortix System or standard medical care.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety for 30 days after the procedure. Effectiveness will also be measured up to 30 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05677100
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
Recruiting
NAAges 21+InterventionalTreatmentProcyrion
~320 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Aortix System
At a glance
Recruiting sites
33 of 50 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of Follow-up.
Measured over Baseline to 30 day Follow-Up
+1 more outcome measured
Conditions
NCT05677100
Where you'd take part
This study runs at 50 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
BayCare Medical/St. Joseph's Hospital
Tampa, Floridastudy coordinator listed
Recruiting
Mayo Clinic - Arizona
Phoenix, Arizonastudy coordinator listed
Recruiting
New York Presbyterian - Brooklyn Methodist Hospital
Brooklyn, New Yorkstudy coordinator listed
Recruiting
Semmelweis University
Budapest, Hungarystudy coordinator listed
Recruiting
AdventHealth Tampa
Tampa, Floridano site contact published
Recruiting
Advocate IMMC
Chicago, Illinoisno site contact published
Recruiting
AnMed Health
Anderson, South Carolinano site contact published
Recruiting
Ascenscion Alexian Brothers
Elk Grove Village, Illinoisno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Eligibility criteria
Inclusion
Currently admitted to the hospital with a primary diagnosis of decompensated heart failure, irrespective of ejection fraction (EF);
Patients should be on maximally tolerated diuretic therapy and not diuresing sufficiently before being enrolled in DRAIN-HF. After being up-titrated on diuretics, patients should be followed for at least 24 hours on the higher of: i) furosemide 80 mg IV bid or equivalent or ii) IV furosemide or equivalent IV loop diuretic at a dose 2.5 x total daily home dose of furosemide equivalents in 2 divided doses, as tolerated, patient must have: Urine Output \<1,500mL in a 12-hour period OR a Net Fluid Loss ≤375mL in a 12-hour period.
Persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \>12 cm water or ascites after treatment with IV diuretics per inclusion criterion 2.;
Age \>21 years and able to provide written informed consent;
Negative pregnancy test if patient is of child-bearing potential.
Currently admitted to the hospital with a primary diagnosis of decompensated HF, irrespective of ejection fraction (EF).
Patient has already been evaluated and indicated to receive an LVAD or heart transplant and will receive the LVAD or be listed for heart transplantation in the next 30 days if their congestion status and renal function improves.
Patient must have been treated with ≥ 80 mg IV furosemide bid or equivalent and have evidence of increasing diuretic dosing requirements over the past 12 months, as tolerated.
Must have evidence of refractoriness to medical management as documented by persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \>12 cm water, or ascites after treatment with IV diuretics for a minimum of 24 hours.
Serum creatinine ≥ 2.0 mg/dL AND eGFR ≤ 45 ml/min/1.73m2 at time of enrollment
Age ≥ 21 years and able to provide written informed consent.
Negative pregnancy test if patient is of childbearing potential.
Exclusion
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;
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 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;
Confirmed diagnosis of AL amyloidosis;
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.
Treatment with high dose IV inotropes within 48 hours prior to enrollment. High dose is defined as any one of the following: \>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 \<80 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \<55 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.
Acute kidney failure defined as an increase in serum creatinine to ≥ 4.0mg/dL at enrollment.
Evidence of contrast-induced nephropathy, nephritis, or nephrotic syndrome.
Prior kidney transplant, single kidney, partial nephrectomy 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.
Current or previous support with a durable LVAD.
INTERMACS Profile 1 at enrollment.
Currently on mechanical ventilatory support.
Use of an extracorporeal membrane oxygenation (ECMO) or percutaneous ventricular assist device (e.g., Impella or TandemHeart) within the last 30 days.
Confirmed diagnosis of AL amyloidosis.
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):
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.
GI bleeding within 6 months requiring hospitalization and/or transfusion.
Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding.
Procedure with arterial ilio-femoral access \> 6 Fr within 30 days.
Platelet count \<75,000 cells/mm3 .
Uncorrectable bleeding diathesis or coagulopathy (e.g., INR≥ 2 not due to anticoagulation therapy) or hypercoagulable state including HIT.
Inability to tolerate anticoagulation therapy for up to 7 days.
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 21 Fr (outer diameter) introducer sheath.
Femoral artery depth inconsistent with use of closure device.
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.
Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction/removal of the Aortix pump as demonstrated by imaging.
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, device implant and retrieval procedures, or return for 30-day visit.
What this trial measures
- Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of Follow-up.Baseline to 30 day Follow-Up
Incidence of Major Adverse Events
- Primary Effectiveness Endpoint: Combined composite of clinically significant reduction in net fluid loss over 7 days and freedom from mortality or heart failure re-hospitalization/therapy escalation from the baseline visit to the 30-day follow-up visit.Baseline to 30 day Follow-Up
Composite of net fluid loss, mortality and HF hospitalization/escalation of therapy