Heart; Decompensation, Congestive Clinical Trial
Official title:
The Safety and Feasibility of the eLym™ System for the Decongestion of Excess Lymphatic Fluid Via the Thoracic Duct in Acute Decompensated Heart Failure
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 72 hours to treat congestion. The patient will be followed during the hospital stay through discharge and have follow-up assessments at 30-, 90- and 180-days.
n/a