New heart pump could help when diuretics fail in acute heart failure

NCT ID NCT05677100

Disease control Sponsor: Procyrion Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 5 times

Summary

This study tests a device called Aortix, a small pump placed in the main artery, to help remove excess fluid in people hospitalized with acute heart failure who are not responding well to diuretic medications. About 320 participants will be randomly assigned to receive either the Aortix pump plus standard care or standard care alone. The goal is to see if the device improves fluid loss and reduces the risk of death or repeat hospitalizations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Aortix System (a pump device placed in the aorta to help the heart and kidneys remove excess fluid)
What this could lead to: If successful, this device could offer a new option for heart failure patients who don't respond well to standard diuretics, potentially reducing hospital readmissions and improving fluid removal.
What could go wrong: This is an early-stage trial (no phase assigned) with 320 participants, so results may not apply to all patients. The device is invasive and carries risks like any implanted pump, including infection or device-related complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (Randomized Study): * 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. 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; * 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): 1. 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, 2. GI bleeding within 6 months requiring hospitalization and/or transfusion, 3. Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding, 4. Procedure with arterial ilio-femoral access \> 6 FR within 30 days, 5. Platelet count \<75,000 cells/mm3, 6. Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy) or hypercoaguable state including HIT; 7. Inability to tolerate anticoagulation therapy for up to 7 days. * Contraindicated Anatomy : 1. Descending aortic anatomy that would prevent safe placement of the device \[\<18 mm or \>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\], 2. Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath, 3. Femoral artery depth inconsistent with use of closure device, 4. 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), 5. Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury, 6. 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 (imaging, PA Catheter placement), device implant and retrieval procedures or return for 30-day visit. Inclusion Criteria (Advanced Heart Failure Registry): * 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 Criteria (Advanced Heart Failure Registry): * 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.

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Conditions

The condition(s) this trial relates to.

cardio-renal syndrome congestive heart failure diastolic heart failure heart failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADHF Cardio-renal syndrome Cardiorenal syndrome Heart failure Heart failure, congestive Heart failure, diastolic Heart failure, systolic Heart failure; with decompensation

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

33 sites in 2 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AdventHealth Tampa
RECRUITING

Tampa, Florida, 33613, United States
Advocate Aurora - Good Samaritan
TERMINATED

Downers Grove, Illinois, 60515, United States
Advocate IMMC
RECRUITING

Chicago, Illinois, 60657, United States
AnMed Health
RECRUITING

Anderson, South Carolina, 29621, United States
Ascenscion Alexian Brothers
RECRUITING

Elk Grove Village, Illinois, 60007, United States
Ascension Sacred Heart
WITHDRAWN

Pensacola, Florida, 32504, United States
Ascension via Christi Kansas
TERMINATED

Wichita, Kansas, 67226, United States
Atrium Health Sanger Heart and Vascular Institute
RECRUITING

Charlotte, North Carolina, 28204, United States
Banner--University Medical Center Phoenix
RECRUITING

Phoenix, Arizona, 85006, United States
BayCare Medical/St. Joseph's Hospital
RECRUITING

Tampa, Florida, 33607, United States
Baylor Scott & White
WITHDRAWN

Fort Worth, Texas, 76104, United States
Baylor Scott & White
WITHDRAWN

Plano, Texas, 75093, United States
Broward Health
RECRUITING

Fort Lauderdale, Florida, 33316, United States
Cleveland Clinic Florida
RECRUITING

Weston, Florida, 33331, United States
Duke University Medical Center
ACTIVE_NOT_RECRUITING

Durham, North Carolina, 27710, United States
Emory University Hospital
RECRUITING

Atlanta, Georgia, 30308, United States
Hackensack University Medical Center
RECRUITING

Hackensack, New Jersey, 07601, United States
Henry Ford
RECRUITING

Detroit, Michigan, 48202, United States
HonorHealth Medical Center
TERMINATED

Scottsdale, Arizona, 85258, United States
Intermountain Health
WITHDRAWN

Murray, Utah, 84107, United States
Jefferson Abington Hospital
RECRUITING

Abington, Pennsylvania, 19001, United States
Jersey Shore University Medical Center
RECRUITING

Neptune City, New Jersey, 07753, United States
John Muir Health
RECRUITING

Concord, California, 94520, United States
Mayo Clinic - Arizona
RECRUITING

Phoenix, Arizona, 85054, United States
Mount Sinai Morningside
RECRUITING

New York, New York, 10025, United States
New York Presbyterian - Brooklyn Methodist Hospital
RECRUITING

Brooklyn, New York, 11215, United States
Northwell Health (Lenox Hill)
TERMINATED

New York, New York, 10075, United States
Northwell Health (Staten Island)
RECRUITING

Staten Island, New York, 10305, United States
Novant Health New Hanover Regional Medical Center
WITHDRAWN

Wilmington, North Carolina, 28401, United States
Nuvance Health
RECRUITING

Poughkeepsie, New York, 12601, United States
Nyph/Cumc
RECRUITING

New York, New York, 10032, United States
Oklahoma Cardiovascular Research Group
RECRUITING

Oklahoma City, Oklahoma, 73120, United States
Oregon Health & Sciences University
ACTIVE_NOT_RECRUITING

Portland, Oregon, 97239, United States
Penn Presbyterian Medical Center
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Piedmont Healthcare Inc.
RECRUITING

Augusta, Georgia, 30309, United States
San Francisco Veterans Administration
TERMINATED

San Francisco, California, 94121, United States
Semmelweis University
RECRUITING

Budapest, Hungary
Tallahassee Research Institute
TERMINATED

Tallahassee, Florida, 32308, United States
Texas Heart Institute
RECRUITING

Houston, Texas, 77030, United States
The Ohio State University
RECRUITING

Columbus, Ohio, 43210, United States
Thomas Jefferson University Hospital
WITHDRAWN

Philadelphia, Pennsylvania, 19107, United States
University of California San Francisco
RECRUITING

San Francisco, California, 94143, United States
University of Chicago
RECRUITING

Chicago, Illinois, 60637, United States
University of Michigan, Cardiovascular Medicine
WITHDRAWN

Ann Arbor, Michigan, 48109, United States
University of Mississippi Medical Center
RECRUITING

Jackson, Mississippi, 39216, United States
University of South Florida
RECRUITING

Tampa, Florida, 33606, United States
University of Virginia
TERMINATED

Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University
RECRUITING

Richmond, Virginia, 23219, United States
Wellstar Research Institue
TERMINATED

Marietta, Georgia, 30060, United States
Zuckerberg San Francisco General
RECRUITING

San Francisco, California, 94110, United States

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