The Safety and Feasibility of the eLym™ System

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 28, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2026

Conditions
Heart; Decompensation, Congestive
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 72 hours.

Trial Locations (9)

46010

RECRUITING

Hospital Clinico Universitario de Valencia, Valencia

0112

TERMINATED

Israeli-Georgian Medical Research Clinical Helsicore, Tbilisi

0159

RECRUITING

Tbilisi Heart and Vascular Center, Tbilisi

0186

RECRUITING

Tbilisi Heart Centre, Tbilisi

50-556

RECRUITING

Wroclaw University Hospital and Clinics, Wroclaw

Unknown

RECRUITING

Hospital Clinic de Barcelona, Barcelona

RECRUITING

Hospital 12 de Octubre, Madrid

RECRUITING

Hospital Clínico de Valladolid, Valladolid

08916

RECRUITING

Germans Trias i Pujol Hospital, Badalona

All Listed Sponsors
lead

WhiteSwell, Limited

INDUSTRY