Clinical trialNCT05747196RecruitingInterventional

The Safety and Feasibility of the eLym™ System

SponsorWhiteSwell, LimitedEnrollment70Heart; Decompensation, Congestive

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

William Abraham, MD
Ohio State University
Study DirectorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Georgia

Israeli-Georgian Medical Research Clinical Helsicore
Tbilisi, Georgia, Georgia
Terminated
Tbilisi Heart Centre
Tbilisi, Georgia, Georgia
Archil Chukhrukidze, MD
Recruiting
Tbilisi Heart and Vascular Center
Tbilisi, Georgia, Georgia
George Khabeishvili, MD
Recruiting

Poland

Wroclaw University Hospital and Clinics
Wroclaw, Poland
Recruiting

Spain

Hospital Clinic de Barcelona
Barcelona, Spain, Spain
Omar Abdul-Jawad Altisent
Recruiting
Germans Trias I Pujol Hospital
Badalona, Spain
Recruiting
Hospital 12 de Octubre
Madrid, Spain
Jorge NucheMaría Dolores García-Cosío
Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
Recruiting
Hospital Clinico San Carlos
San Carlos, Spain
Recruiting
Hospital Clinico Universitario de Valencia
Valencia, Spain
Recruiting
Hospital Clínico de Valladolid
Valladolid, Spain
Ignacio AmatJavier López
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 28 Feb 2023
Primary completion: 31 Dec 2026
Completion: 31 Dec 2026
Last update posted: 7 Jan 2026
Registered enrollment: 70
Registry id: NCT05747196

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.