Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
NCT ID: NCT05677100
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
295 participants
INTERVENTIONAL
2023-08-23
2026-12-31
Brief Summary
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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.
Detailed Description
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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 295 subjects with heart failure at 45 clinical sites in the United States and up to 5 OUS sites. The randomized study includes up to 215 subjects and the Advanced HF registry includes up to 80 subjects.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Arm
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.
Aortix System
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 are resistant to diuretic therapy.
Control Arm
The Control arm should receive standard of care therapy as per the study directed Diuretic Care Treatment Algorithm.
No interventions assigned to this group
Advanced HF Registry
For the Advanced HF registry, all eligible enrolled subjects will receive Aortix system support.
Aortix System
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 are resistant to diuretic therapy.
Interventions
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Aortix System
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 are resistant to diuretic therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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 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):
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.
* 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 intra-aortic balloon pump (IABP) within the last 14 days or use of an extracorporeal membrane oxygenation (ECMO) or percutaneous ventricular assist device (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):
* 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.
21 Years
ALL
No
Sponsors
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Procyrion
INDUSTRY
Responsible Party
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Locations
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Banner--University Medical Center Phoenix
Phoenix, Arizona, United States
Mayo Clinic - Arizona
Phoenix, Arizona, United States
HonorHealth Medical Center
Scottsdale, Arizona, United States
John Muir Health
Concord, California, United States
Zuckerberg San Francisco General
San Francisco, California, United States
San Francisco Veterans Administration
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
Ascension Sacred Heart
Pensacola, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
University of South Florida
Tampa, Florida, United States
BayCare Medical/St. Joseph's Hospital
Tampa, Florida, United States
AdventHealth Tampa
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Piedmont Healthcare Inc.
Augusta, Georgia, United States
Wellstar Research Institue
Marietta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Advocate IMMC
Chicago, Illinois, United States
Advocate Aurora - Good Samaritan
Downers Grove, Illinois, United States
Ascension via Christi Kansas
Wichita, Kansas, United States
University of Michigan, Cardiovascular Medicine
Ann Arbor, Michigan, United States
Henry Ford
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
New York Presbyterian - Brooklyn Methodist Hospital
Brooklyn, New York, United States
Mount Sinai Morningside
New York, New York, United States
Nyph/Cumc
New York, New York, United States
Northwell Health (Lenox Hill)
New York, New York, United States
Nuvance Health
Poughkeepsie, New York, United States
Northwell Health (Staten Island)
Staten Island, New York, United States
Atrium Health Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States
Oregon Health & Sciences University
Portland, Oregon, United States
Jefferson Abington Hospital
Abington, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Baylor Scott & White Research Institute
Fort Worth, Texas, United States
Texas Heart Institute
Houston, Texas, United States
Baylor Scott & White
Plano, Texas, United States
Intermountain Health
Murray, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Semmelweis University
Budapest, , Hungary
Countries
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Central Contacts
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Facility Contacts
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Abisola Akinbobola, MSc
Role: primary
Alexandra Gaughan, R.N.
Role: primary
Rita Trachuk
Role: primary
Katherine Steineman
Role: primary
Cynthia Huynh
Role: primary
Cherry Ng
Role: primary
Wendie Najdowski, RN
Role: primary
Mia Eifrid
Role: primary
Nirav Raval, MD
Role: primary
Cynthia Paysor, LPN
Role: primary
Juan Armijos
Role: primary
Wei Xu
Role: primary
Jennifer Hansen
Role: primary
Amuthanayaki Kanagaraj
Role: primary
Kristen Hanauer
Role: primary
Maci Eiber
Role: primary
Debra Heidenreich
Role: primary
Kristen Thomas
Role: primary
Kelsey Neaton
Role: primary
Memrie Cochran
Role: primary
Stephanie Lynes
Role: primary
Anne DeToro
Role: primary
Jhane Phanor
Role: primary
Kathy Idrissi
Role: primary
Barbara Alvarez
Role: primary
Tricia Landi
Role: primary
Sammi Ruan
Role: primary
Zaida Roman
Role: primary
Kimberly Biever
Role: primary
Lyn Lanier
Role: primary
Diane Burke
Role: primary
Katie Kennedy
Role: primary
Colleen Marchand
Role: primary
Margaret Bussineau
Role: primary
Maura Wasilewski
Role: primary
Jess Amos
Role: backup
Jeanine Bacani
Role: primary
Daniel Babcock
Role: primary
Melissa Sears
Role: primary
Laura Kosa-Hobor
Role: primary
Other Identifiers
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CSP001
Identifier Type: -
Identifier Source: org_study_id