The Safety and Feasibility of the eLym™ System

Official title

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

Overview

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.

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

Primary outcome measures

• Acute safety as assessed by the rate of acute adjudicated device-, treatment-, and procedure-related Serious Adverse Events [Time frame: Device placement skin puncture to 30 days post therapy]
• Chronic safety as assessed by the rate of chronic adjudicated device-, treatment-, and procedure-related Serious Adverse Events (SAE) [Time frame: Day 31 out to 180 days post therapy]
• Technical system performance as measured by the rate of procedures that demonstrate the user's ability to deploy, activate and remove the system. [Time frame: Device placement procedure through eLym System therapy end (therapy lasting less than or equal to 72 hours)]
• Acute response to therapy as evaluated by changes in the patients' body weight [Time frame: Baseline (prior to eLym therapy), after eLym therapy (less than or equal to 72 hours after therapy initiation) and at discharge from the hospital (expected 3 - 10 days after hospital admission)]
• Acute response to therapy as evaluated by changes in patients' net fluid loss or gain (milliliters) [Time frame: Baseline (prior to eLym therapy), after eLym therapy (less than or equal to 72 hours after therapy initiation) and at discharge from the hospital (expected 3 - 10 days after hospital admission)]
• Acute response to therapy as evaluated by assessing changes in patients' renal function using estimated glomerular filtration rate (eGFR) [Time frame: Baseline (prior to eLym therapy), after eLym therapy (less than or equal to 72 hours after therapy initiation), discharge from the hospital (expected 3 - 10 days after hospital admission), and at 30 day follow-up]
• Acute response to therapy as evaluated by assessing changes in patients' renal function using laboratory parameter serum creatinine [Time frame: Baseline (prior to eLym therapy), after eLym therapy (less than or equal to 72 hours after therapy initiation), discharge from the hospital (expected 3 - 10 days after hospital admission), and at 30 day follow-up]
• Acute response to therapy as evaluated by the need for intensified heart failure therapy(ies) over the course of the hospitalization [Time frame: Patient enrollment through hospital discharge (typically 3 - 10 days from admission to the hospital)]
• Acute response to therapy as evaluated by assessing Extra Vascular Lung Water (EVLW) measured by Sensible Medical's ReDS technology. [Time frame: Baseline (pre eLym System therapy) and post eLym System therapy (less than or equal to 72 hours after the initiation of therapy)]
• Patient Quality of Life as evaluated by the Kansas City Quality of Life Questionnaire (KCCQ). [Time frame: Baseline, Hospital discharge (typically 3- 10 days post hospital admission), 30-, 90-, and 180-days after hospital discharge.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• Ultrasound Screening Assessment Exclusion:

• Subjects' anatomy is not compatible with product dimensions as defined on the eLym system labelling
• Subjects requiring intravenous vasoactive therapies (e.g., vasodilators, inodilators, inotropes), mechanical ventilation, MCS, or ultrafiltration
• Subject has experienced a thromboembolic event \[e.g., pulmonary embolism (PE), deep vein thrombosis (DVT), transient ischemic attack (TIA), or cerebrovascular events (CVA)\] within the previous 6 months
• Subject has contraindications to systemic anticoagulation
• Subject currently on Dabigatran
• Subject with International Normalized Ratio (INR) >2.2 not due to anticoagulation therapy, hypercoagulable state including heparin-induced thrombocytopenia, or on novel anticoagulants (NOACs) that cannot be held for a minimum of 24 hours prior to eLym System placement Note: If subject's INR is >2.2 at the screening and baseline assessment, it may be repeated to assess eligibility up to the time of the procedure.
• Previous intracranial bleed unless there is documentation that the patient can safely use anticoagulation for 3 days
• Gastrointestinal (GI) bleeding within 6 months requiring hospitalization and/or transfusion.
• Recent major surgery within 30 days if the surgical would is judged to be associated with increased risk of bleeding.
• Platelet count <75 10\^3/μL
• Inability to tolerate anticoagulation therapy for up to 3 days
• Subject with systolic blood pressure <85 millimeters of mercury (mmHg) at time of enrollment
• Subject has severe liver disease, liver fibrosis, or hempatorenal syndrome
• Subject has evidence of active blood stream infection or pneumonia
• Sustained malignant arrhythmias \[e.g., ventricular tachycardia/fibrillation) in the last 90 days\]
• Subject with acute coronary syndrome (ACS) in the last 3 months
• Subject with severe concomitant disease expected to prolong hospitalization or expected to cause death in ≤ 90 days
• Subject with a rhythm management device implanted within the last 45 days (i.e., cardioverter/defibrillator, pacemaker, cardiac resynchronization device)
• Subject is pregnant or lactating. Women of childbearing age who are not post-menopausal or not surgically sterile will need to demonstrate a negative urine or serum test.
• Physician discretion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

Spain · 7 centers

• Hospital Clinic de Barcelona — Barcelona
• Germans Trias i Pujol Hospital — Badalona
• Hospital 12 de Octubre — Madrid
• Hospital Universitario Puerta de Hierro Majadahonda — Majadahonda
• Hospital Clinico San Carlos — San Carlos
• Hospital Clinico Universitario de Valencia — Valencia
• Hospital Clínico de Valladolid — Valladolid

Georgia · 3 centers

• Israeli-Georgian Medical Research Clinical Helsicore — Tbilisi
• Tbilisi Heart and Vascular Center — Tbilisi
• Tbilisi Heart Centre — Tbilisi

Poland · 1 center

• Wroclaw University Hospital and Clinics — Wroclaw

Publications

• Biegus J, Lindenfeld J, Felker GM, Bakris G, Jonas M, Lala A, Kereselidze Z, Khabeishvili G, Gogorishvili I, Nunez J, Bayes-Genis A, Ponikowski P, Abraham WT. Design and rationale of the eLym System for Decompensation of Excess Lymphatic Fluid via the Thoracic Duct in Acute Heart Failure (DELTA-HF). ESC Heart Fail. 2025 Jun;12(3):1719-1726. doi: 10.1002/ehf2.15192. Epub 2024 Dec 24. PMID 39716986

Identifiers

NCT: NCT05747196 · DELTA-HF CIP-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗