Evaluating the eLym System for treating fluid overload in heart failure patients

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

This study is testing a new device called the eLym System to see if it can safely help heart failure patients in the hospital who have too much fluid in their bodies.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: WhiteSwell, Limited (Industry-sponsored)
• Locations: 11 sites (Tbilisi, Georgia and 10 other locations)
• Trial ID: NCT05747196 on ClinicalTrials.gov

What this trial studies

This feasibility study assesses the safety and performance of the WhiteSwell eLym System in adults hospitalized with Acute Decompensated Heart Failure (ADHF) experiencing fluid overload. The device will be temporarily placed in patients for up to 72 hours to alleviate congestion, with safety monitored over 30 to 180 days. Participants will be screened based on specific clinical criteria and followed closely during their hospital stay and at subsequent follow-up visits.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are hospitalized with Acute Decompensated Heart Failure and exhibit signs of fluid overload.

Not a fit: Patients with stable heart failure who do not require intravenous diuretics or those with contraindications to the eLym System may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from fluid overload due to heart failure.

How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a novel investigation.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years
2. Subject is admitted to the hospital with a primary diagnosis of Acute Decompensated Heart Failure (ADHF)
3. 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.
4. Total DAILY diuretic dose prior to admission of ≥80mg Lasix or equivalent
5. Renal function parameters as measured by estimated glomerular filtration rate (eGFR) ≥20 ml/min/1.73m2
6. 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.
7. 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).
8. Albumin \>2.5 g/dL
9. 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
10. Subject willing and able to complete study assessments and agrees to comply with all follow-up evaluations
11. Subject has provided written informed consent

Exclusion Criteria:

1. Ultrasound Screening Assessment Exclusion:

   * Subjects' anatomy is not compatible with product dimensions as defined on the eLym system labelling
2. Subjects requiring intravenous vasoactive therapies (e.g., vasodilators, inodilators, inotropes), mechanical ventilation, MCS, or ultrafiltration
3. 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
4. Subject has contraindications to systemic anticoagulation
5. Subject currently on Dabigatran
6. 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.
7. Previous intracranial bleed unless there is documentation that the patient can safely use anticoagulation for 3 days
8. Gastrointestinal (GI) bleeding within 6 months requiring hospitalization and/or transfusion.
9. Recent major surgery within 30 days if the surgical would is judged to be associated with increased risk of bleeding.
10. Platelet count \<75 10\^3/μL
11. Inability to tolerate anticoagulation therapy for up to 3 days
12. Subject with systolic blood pressure \<85 millimeters of mercury (mmHg) at time of enrollment
13. Subject has severe liver disease, liver fibrosis, or hempatorenal syndrome
14. Subject has evidence of active blood stream infection or pneumonia
15. Sustained malignant arrhythmias \[e.g., ventricular tachycardia/fibrillation) in the last 90 days\]
16. Subject with acute coronary syndrome (ACS) in the last 3 months
17. Subject with severe concomitant disease expected to prolong hospitalization or expected to cause death in ≤ 90 days
18. Subject with a rhythm management device implanted within the last 45 days (i.e., cardioverter/defibrillator, pacemaker, cardiac resynchronization device)
19. 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.
20. Physician discretion

Where this trial is running

Tbilisi, Georgia and 10 other locations

• Israeli-Georgian Medical Research Clinical Helsicore — Tbilisi, Georgia, Georgia (Terminated)
• Tbilisi Heart and Vascular Center — Tbilisi, Georgia, Georgia (Recruiting)
• Tbilisi Heart Centre — Tbilisi, Georgia, Georgia (Recruiting)
• Wroclaw University Hospital and Clinics — Wroclaw, Poland (Recruiting)
• Hospital Clinic de Barcelona — Barcelona, Spain, Spain (Recruiting)
• Germans Trias i Pujol Hospital — Badalona, Spain (Recruiting)
• Hospital 12 de Octubre — Madrid, Spain (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 (Recruiting)

Study contacts

• Study coordinator: Sergio Shkurovich

Conditions Heart; Decompensation, Congestive