San Fernando

Researchers are evaluating the safety and performance of the WhiteSwell eLym System in adults hospitalized with Acute Decompensated Heart Failure (ADHF) who have fluid overload or congestion. This feasibility study aims to assess acute and chronic device safety, technical success, and patient treatment outcomes over time. The study focuses on how the system may help manage fluid overload in these patients during and after hospital care. The WhiteSwell eLym System is a device consisting of a catheter and sheath used together with a console. It is temporarily placed in a heart catheterization lab and remains in place for up to 60 hours. The device creates a low-pressure area near the thoracic duct outflow to help move lymphatic fluid back into the bloodstream, while patients continue to receive diuretic therapy to remove excess fluid. Treatment is delivered during hospitalization, followed by monitoring after discharge. Participants will be monitored throughout their hospital stay and will have follow-up visits at 30, 60, 90, and 180 days after discharge. Researchers will collect data on safety events, device performance, changes in body weight, fluid balance, kidney function, lung water content, and quality of life using questionnaires. They will also track heart failure therapies, lab biomarkers, and rates of rehospitalization for up to six months to evaluate both short-term and long-term effects of the treatment.