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RECRUITING
NCT05677100
NA

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

Sponsor: Procyrion

View on ClinicalTrials.gov

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.

Official title: DRAIN-HF: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2023-08-23

Completion Date

2027-08

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (48)

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

AnMed Health

Anderson, South Carolina, United States

Baylor Scott & White

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