Heart failure fluid removal device trial halted early

NCT ID NCT05318105

Terminated Disease control Sponsor: Nuwellis, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared a device called Aquadex, which filters excess fluid from the blood, to standard IV diuretics in 167 hospitalized heart failure patients with fluid overload. The goal was to see which method better prevented heart failure events like rehospitalization. However, the trial was terminated early, so the results are incomplete and should be interpreted with caution.

What this could mean

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

Active substance: Aquadex Smartflow System (a device that removes excess fluid from the blood) and IV loop diuretics (medication to increase urine output)
What this could lead to: If successful, this could provide a more effective way to remove excess fluid in heart failure patients, potentially reducing hospital readmissions.
What could go wrong: The trial was terminated early, meaning it did not complete as planned. This limits the reliability of any findings, and the device may not prove better than standard diuretics.

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

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Conditions

The condition(s) this trial relates to.

congestive heart failure Edema heart failure

As listed by the trial registrant

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

FLUID OVERLOAD HEART FAILURE HEART FAILURE (FOR EXAMPLE, FLUID OVERLOAD)

Contacts and locations

Locations

Abington Jefferson Health

Abington, Pennsylvania, 19001, United States
Banner Health

Tucson, Arizona, 85721, United States
BayCare Medical Group, Morton Plant

Clearwater, Florida, 33756, United States
Baylor Scott & White Research Institute

Dallas, Texas, 75207, United States
Henry Ford Health

Detroit, Michigan, 48202, United States
Jackson Madison County General Hospital

Jackson, Tennessee, 38301, United States
MemorialCare, Long Beach Medical Center

Long Beach, California, 90806, United States
Mount Sinai Morningside

New York, New York, 10025, United States
Northwell Health

New York, New York, 10075, United States
Sentara Norfolk General Heart Hospital

Norfolk, Virginia, 23507, United States
Sharp Memorial Hospital, San Diego Cardiac Center

San Diego, California, 92123, United States
The Christ Hospital

Cincinnati, Ohio, 45219, United States
The Mount Sinai Hospital

New York, New York, 10029, United States
The Ohio State University

Columbus, Ohio, 43215, United States
University of Kentucky

Lexington, Kentucky, 40536, United States

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