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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 72 hours to treat congestion. The patient will be followed during the hospital stay through discharge and have follow-up assessments at 30-, 90- and 180-days.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Subject is admitted to the hospital with a primary diagnosis of Acute Decompensated Heart Failure (ADHF)

• Subjects receiving intravenous (IV) diuretic for decompensated heart failure and demonstrating fluid overload. This includes peripheral edema ≥2+ (on a 0 to 4+ scale) and a minimum of 1 of the following:

‣ Jugular venous distension ≥10 cm H20;

⁃ Pulmonary edema as determined by auscultation or imaging;

⁃ Hepatojugular reflux;

⁃ Paroxysmal nocturnal dyspnea or ≥ two-pillow orthopnea;

⁃ Dyspnea at rest with respiration rate ≥20 per minute.

• Total DAILY diuretic dose prior to admission of ≥80mg Lasix or equivalent

• Renal function parameters as measured by estimated glomerular filtration rate (eGFR) ≥20 ml/min/1.73m2

• Subject must meet on one of the following criteria:

‣ Subject has had a heart failure hospitalization or worsening of heart failure event requiring IV diuretic therapy (in hospital, emergency room, urgent care, or HF clinic) within the previous 6 months;

⁃ Renal function as measured by eGFR ≥20 and ≤45 ml/min/1.73m2;

⁃ At initial HF admission, \<600 ml of urine output within 6 hours of initial IV bolus or urine sodium of \<50 mmol/L at 1-2 hours after initial IV diuretic dose.

• Elevated N-Terminal (NT) Pro B-type Natriuretic Peptide (BNP) or BNP:

‣ NT Pro BNP \>1000 pg/ml (\>1500 for subjects with atrial fibrillation);

⁃ BNP \>250 pg/ml (\>375 for subjects with atrial fibrillation).

• Albumin \>2.5 g/dL

• Subject must be able to have device placement procedure within 96 hours of presentation to the hospital and still be demonstrating fluid overload at the time of device placement

⁃ Subject willing and able to complete study assessments and agrees to comply with all follow-up evaluations

⁃ Subject has provided written informed consent

Locations
Other Locations
Georgia
Israeli-Georgian Medical Research Clinical Helsicore
TERMINATED
Tbilisi
Tbilisi Heart and Vascular Center
RECRUITING
Tbilisi
Tbilisi Heart Centre
RECRUITING
Tbilisi
Poland
Wroclaw University Hospital and Clinics
RECRUITING
Wroclaw
Spain
Germans Trias i Pujol Hospital
RECRUITING
Badalona
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital 12 de Octubre
RECRUITING
Madrid
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Hospital Clínico de Valladolid
RECRUITING
Valladolid
Contact Information
Primary
Sergio Shkurovich
sergio@whiteswell.com
+1(818)207-7743
Time Frame
Start Date: 2023-02-28
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Treatments
Experimental: Open Label Treatment Arm
Hospitalized patients with acute decompensated heart failure that meet eligibility criteria will have an eLym System temporarily placed via left internal jugular access. The eLym System will be in place for up to 72 hours.
Related Therapeutic Areas
Sponsors
Leads: WhiteSwell, Limited

This content was sourced from clinicaltrials.gov