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The Safety and Feasibility of the eLym™ System
Sponsor: WhiteSwell, Limited
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2023-02-28
Completion Date
2026-12
Last Updated
2026-01-07
Healthy Volunteers
No
Conditions
Interventions
WhiteSwell eLym System
The WhiteSwell eLym™ System is designed to treat congestion in Acute Decompensated Heart Failure (ADHF) patients. The device comprises two endovascular components, a Catheter and a Sheath, that are used in combination with a Console. The device is designed to create a low-pressure zone at the Thoracic Duct Outflow which is located adjacent to the venous angle (junction of the left subclavian vein and left internal jugular vein). This low-pressure region facilitates movement of fluid (lymph) from the interstitial compartment through the lymphatic system and the Thoracic Duct and into the intravascular space, while removal of fluids from the intravascular space is enabled using diuretic therapy. The treatment duration will be up to 60 hours.
Locations (11)
Israeli-Georgian Medical Research Clinical Helsicore
Tbilisi, Georgia, Georgia
Tbilisi Heart and Vascular Center
Tbilisi, Georgia, Georgia
Tbilisi Heart Centre
Tbilisi, Georgia, Georgia
Wroclaw University Hospital and Clinics
Wroclaw, Poland
Hospital Clinic de Barcelona
Barcelona, Spain, Spain
Germans Trias i Pujol Hospital
Badalona, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
Hospital Clinico San Carlos
San Carlos, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Hospital Clínico de Valladolid
Valladolid, Spain