The goal of this feasibility study is to evaluated the safety and performance of the WhiteSwell eLym System in the treatment of fluid overload or congestion in adult patients with Acute Decompensated Heart Failure (ADHF). The main question\[s\] it aims to answer are: * Acute device safety (30 days) * Chronic device safety (31-180 days) * Primary performance Outcomes (Technical success and patient treatment outcomes) Participants who are hospitalized for ADHF will be screened for treatment with the eLym System. The System, placed in a heart catheterization laboratory, will be temporarily placed for up to 60 hours to treat congestion. The patient will be followed during the hospital stay through discharge and have follow-up assessments at 30-, 60-, 90- and 180-days.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Acute safety as assessed by the rate of acute adjudicated device-, treatment-, and procedure-related Serious Adverse Events
Timeframe: Device placement skin puncture to 30 days post therapy
Chronic safety as assessed by the rate of chronic adjudicated device-, treatment-, and procedure-related Serious Adverse Events (SAE)
Timeframe: Day 31 out to 180 days post therapy
Technical system performance as measured by the rate of procedures that demonstrate the user's ability to deploy, activate and remove the system.
Timeframe: Device placement procedure through eLym System therapy end (therapy lasting less than or equal to 72 hours)
Acute response to therapy as evaluated by changes in the patients' body weight
Timeframe: Baseline (prior to eLym therapy), after eLym therapy (less than or equal to 72 hours after therapy initiation) and at discharge from the hospital (expected 3 - 10 days after hospital admission)
Acute response to therapy as evaluated by changes in patients' net fluid loss or gain (milliliters)
Timeframe: Baseline (prior to eLym therapy), after eLym therapy (less than or equal to 72 hours after therapy initiation) and at discharge from the hospital (expected 3 - 10 days after hospital admission)
Acute response to therapy as evaluated by assessing changes in patients' renal function using estimated glomerular filtration rate (eGFR)
Timeframe: Baseline (prior to eLym therapy), after eLym therapy (less than or equal to 72 hours after therapy initiation), discharge from the hospital (expected 3 - 10 days after hospital admission), and at 30 day follow-up
Acute response to therapy as evaluated by assessing changes in patients' renal function using laboratory parameter serum creatinine
Timeframe: Baseline (prior to eLym therapy), after eLym therapy (less than or equal to 72 hours after therapy initiation), discharge from the hospital (expected 3 - 10 days after hospital admission), and at 30 day follow-up
Acute response to therapy as evaluated by the need for intensified heart failure therapy(ies) over the course of the hospitalization
Timeframe: Patient enrollment through hospital discharge (typically 3 - 10 days from admission to the hospital)
Acute response to therapy as evaluated by assessing Extra Vascular Lung Water (EVLW) measured by Sensible Medical's ReDS technology.
Timeframe: Baseline (pre eLym System therapy) and post eLym System therapy (less than or equal to 72 hours after the initiation of therapy)
Patient Quality of Life as evaluated by the Kansas City Quality of Life Questionnaire (KCCQ).
Timeframe: Baseline, Hospital discharge (typically 3- 10 days post hospital admission), 30-, 90-, and 180-days after hospital discharge.
Chronic response to therapy as evaluated by assessing changes in N Terminal-Pro Brain Natriuretic Peptide (NT-ProBNP) or Brain Natriuretic Peptide (BNP) biomarker levels
Timeframe: Baseline and 30-, 90-, and 180-days after hospital discharge
Long term patient outcomes as evaluated by the time (days) to rehospitalization for acute decompensated heart failure
Timeframe: Hospital discharge through 180 days post hospital discharge