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RECRUITING
NCT05747196
NA

The Safety and Feasibility of the eLym™ System

Sponsor: WhiteSwell, Limited

View on ClinicalTrials.gov

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

Interventions

DEVICE

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