Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
- Conditions
- Heart FailureHeart Failure; With DecompensationHeart Failure, CongestiveCardiorenal SyndromeCardio-Renal SyndromeADHFHeart Failure, DiastolicHeart Failure, Systolic
- Interventions
- Device: Aortix System
- Registration Number
- NCT05677100
- Lead Sponsor
- Procyrion
- Brief Summary
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.
- Detailed 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 295
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Advanced HF Registry Aortix System For the Advanced HF registry, all eligible enrolled subjects will receive Aortix system support. Treatment Arm Aortix System 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Net Fluid Loss Baseline to Day 7 Change in Net Fluid Loss from Baseline to Day 7/Discharge
NT-proBNP Baseline to 30 day Follow-Up Evaluation of NT-proBNP
Incidence and percentages of major adverse events (MAE) Pooled Baseline to 30 day Follow-Up Incidence and percentages of major adverse events (MAE) pooled analysis of Aortix randomized cohort and registry cohort
eGFR Baseline to 30 day Follow-Up Evaluation of changes in eGFR
All-cause Mortality Baseline to 30 day Follow-Up Rate of mortality
Patient Reported Dyspnea Assessment Baseline to 30 day Follow-Up Change in patient reported dyspnea scale
Standing body weight Baseline to 30 day Follow-Up Change in standing body weight
HF Re-Hospitalization or escalation of HF therapy Baseline to 30 day Follow-Up Evaluation of HF re-hospitalization and therapy escalation
Trial Locations
- Locations (45)
Birmingham VA Health Care System
🇺🇸Birmingham, Alabama, United States
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
Cardiovascular Research Institute of 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
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
New York Presbyterian - Brooklyn Methodist Hospital
🇺🇸Brooklyn, New York, United States
Nyph/Cumc
🇺🇸New York City, New York, United States
Mount Sinai Morningside
🇺🇸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
🇺🇸Forth Worth, Texas, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
Intermountain Health
🇺🇸Murray, Utah, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States