Early feasibility study to evaluate safety and performance of the WhiteSwell System in the treatment of fluid overload in hospitalized patients with acutely decompensated heart failure.
This study will evaluate the safety and feasibility of the WhiteSwell System for the treatment of patients hospitalized with acutely decompensated heart failure. Subjects who have been admitted to the hospital less than 72 hours for ADHF will be evaluated for inclusion into the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
9
To promote movement of interstitial fluid to the intravascular space to allow for the body to remove it, in conjunction with a diuresis regimen.
Advocate Health/Edwards Heart Hospital
Naperville, Illinois, United States
Ohio State University
Columbus, Ohio, United States
The Rate of adjudicated device- or procedure-related Serious Adverse Events vents
The rate of adjudicated device- or procedure-related Serious Adverse Events (SAEs). All primary safety endpoints will be reported as-adjudicated by the designated Clinical Events Committee (CEC) during treatment and through the 30-day follow-up period.
Time frame: 30 days
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