60
Participants
Start Date
February 28, 2023
Primary Completion Date
June 30, 2026
Study Completion Date
December 31, 2026
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 72 hours.
RECRUITING
Hospital Clinico Universitario de Valencia, Valencia
TERMINATED
Israeli-Georgian Medical Research Clinical Helsicore, Tbilisi
RECRUITING
Tbilisi Heart and Vascular Center, Tbilisi
RECRUITING
Tbilisi Heart Centre, Tbilisi
RECRUITING
Wroclaw University Hospital and Clinics, Wroclaw
RECRUITING
Hospital Clinic de Barcelona, Barcelona
RECRUITING
Hospital 12 de Octubre, Madrid
RECRUITING
Hospital Clínico de Valladolid, Valladolid
RECRUITING
Germans Trias i Pujol Hospital, Badalona
WhiteSwell, Limited
INDUSTRY