Actively Recruiting
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
Led by Procyrion · Updated on 2026-04-07
320
Participants Needed
48
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently hospitalized with decompensated heart failure regardless of ejection fraction
- On maximum tolerated diuretic therapy but still not producing enough urine or losing enough fluid
- Persistent fluid congestion evidenced by at least 2+ pitting edema, elevated jugular venous pressure over 12 cm water, or ascites despite IV diuretics
- Age 21 years or older and able to give written informed consent
- Negative pregnancy test if of child-bearing potential
You will not qualify if you...
- Use of high dose IV inotropes within 48 hours before enrollment
- Ongoing low blood pressure with systolic below 90 mmHg or mean arterial pressure below 60 mmHg for over 30 minutes
- Use of vasopressors within 48 hours before enrollment
- Pulmonary artery systolic pressure over 80 mmHg or mainly right heart failure on echocardiogram
- Acute kidney failure with serum creatinine 4.0 mg/dL or higher at enrollment
- History of kidney transplant, single kidney, partial nephrectomy, or recent dialysis or renal replacement therapy within 90 days
- Confirmed decompensated cirrhosis or shock liver
- Active uncontrolled infection preventing safe device placement or removal
- Prior heart transplant or planned transplant before 30-day follow-up
- Current or previous durable LVAD support or planned LVAD insertion before 30-day follow-up
- Use of intra-aortic balloon pump, ECMO, or percutaneous ventricular assist devices within last 30 days
- Diagnosis of AL amyloidosis
- Recent acute myocardial infarction or planned coronary procedures within 30 days
- Stroke within 30 days
- Severe bleeding risks including recent intracranial bleed, GI bleeding, major surgery, or coagulopathy
- Contraindicated vascular anatomy preventing safe device placement
- Known allergies or contraindications to study medications or device materials
- Participation in other conflicting clinical trials
- Poor health preventing device procedures or survival to 30-day visit
- Unable or unwilling to undergo study procedures and follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 48 locations
1
Banner--University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Mayo Clinic - Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
HonorHealth Medical Center
Scottsdale, Arizona, United States, 85258
Terminated
4
John Muir Health
Concord, California, United States, 94520
Actively Recruiting
5
Zuckerberg San Francisco General
San Francisco, California, United States, 94110
Actively Recruiting
6
San Francisco Veterans Administration
San Francisco, California, United States, 94121
Actively Recruiting
7
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
8
Ascension Sacred Heart
Pensacola, Florida, United States, 32504
Withdrawn
9
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Active, Not Recruiting
10
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
11
BayCare Medical/St. Joseph's Hospital
Tampa, Florida, United States, 33607
Actively Recruiting
12
AdventHealth Tampa
Tampa, Florida, United States, 33613
Actively Recruiting
13
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Actively Recruiting
14
Emory University Hospital
Atlanta, Georgia, United States, 30308
Actively Recruiting
15
Piedmont Healthcare Inc.
Augusta, Georgia, United States, 30309
Actively Recruiting
16
Wellstar Research Institue
Marietta, Georgia, United States, 30060
Active, Not Recruiting
17
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
18
Advocate IMMC
Chicago, Illinois, United States, 60657
Actively Recruiting
19
Advocate Aurora - Good Samaritan
Downers Grove, Illinois, United States, 60515
Actively Recruiting
20
Ascension via Christi Kansas
Wichita, Kansas, United States, 67226
Terminated
21
University of Michigan, Cardiovascular Medicine
Ann Arbor, Michigan, United States, 48109
Withdrawn
22
Henry Ford
Detroit, Michigan, United States, 48202
Actively Recruiting
23
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
24
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
25
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
26
New York Presbyterian - Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
Actively Recruiting
27
Mount Sinai Morningside
New York, New York, United States, 10025
Actively Recruiting
28
Nyph/Cumc
New York, New York, United States, 10032
Actively Recruiting
29
Northwell Health (Lenox Hill)
New York, New York, United States, 10075
Terminated
30
Nuvance Health
Poughkeepsie, New York, United States, 12601
Actively Recruiting
31
Northwell Health (Staten Island)
Staten Island, New York, United States, 10305
Actively Recruiting
32
Atrium Health Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
33
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
34
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
Actively Recruiting
35
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
36
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
37
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
Active, Not Recruiting
38
Jefferson Abington Hospital
Abington, Pennsylvania, United States, 19001
Actively Recruiting
39
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
40
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
41
AnMed Health
Anderson, South Carolina, United States, 29621
Actively Recruiting
42
Baylor Scott & White
Fort Worth, Texas, United States, 76104
Withdrawn
43
Texas Heart Institute
Houston, Texas, United States, 77030
Actively Recruiting
44
Baylor Scott & White
Plano, Texas, United States, 75093
Withdrawn
45
Intermountain Health
Murray, Utah, United States, 84107
Withdrawn
46
University of Virginia
Charlottesville, Virginia, United States, 22908
Terminated
47
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Actively Recruiting
48
Semmelweis University
Budapest, Hungary
Actively Recruiting
Research Team
R
Rubi Reyes-Fuentez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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