RecruitingNot ApplicableNCT05747196

The Safety and Feasibility of the eLym™ System

The Safety and Feasibility of the eLym™ System for the Decongestion of Excess Lymphatic Fluid Via the Thoracic Duct in Acute Decompensated Heart Failure


Sponsor

WhiteSwell, Limited

Enrollment

70 participants

Start Date

Feb 28, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and feasibility of a new device called the eLym™ System, which is designed to help the body remove excess fluid more effectively in patients hospitalized for severe fluid overload (decompensated heart failure) who are not responding well to standard diuretic (water pill) treatment. **You may be eligible if...** - You are 18 or older and hospitalized for acute decompensated heart failure - You are on IV diuretics and still have significant fluid overload (leg swelling, shortness of breath, etc.) - Your kidney function meets the minimum threshold (eGFR ≥20) - You have had a prior heart failure hospitalization in the last 6 months, reduced kidney function, or poor response to your first IV diuretic dose - Your heart failure markers (BNP or NT-proBNP) are elevated **You may NOT be eligible if...** - You do not have significant fluid overload - Your kidneys are severely impaired (eGFR <20) - You have certain types of heart failure not suitable for the device - You are in cardiogenic shock or require immediate intensive interventions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEWhiteSwell 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

View Full Details on ClinicalTrials.gov

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NCT05747196