Lymph-Draining catheter could ease fluid overload in heart failure
NCT ID NCT05747196
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a device called the eLym System that drains excess fluid from the lymphatic system to treat congestion in people hospitalized with acute decompensated heart failure. The device is placed temporarily for up to 60 hours in a heart catheterization lab. Researchers are checking if it is safe and works as intended in 70 adult patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- WhiteSwell eLym System (a catheter device that creates a low-pressure zone to drain lymphatic fluid)
- What this could lead to
- If it works, this device could offer a new way to quickly remove excess fluid in heart failure patients, potentially reducing symptoms and hospital stays.
- What could go wrong
- This is an early feasibility study with only 70 participants, so the device may not prove safe or effective. Risks include complications from catheter placement and the procedure itself.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2023
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute decompensated heart failure are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
10 sites in 3 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Germans Trias i Pujol Hospital
RECRUITINGBadalona, 08916, Spain
-
Hospital 12 de Octubre
RECRUITINGMadrid, Spain
-
Hospital Clinic de Barcelona
RECRUITINGBarcelona, Spain, Spain
-
Hospital Clinico San Carlos
RECRUITINGSan Carlos, Spain
-
Hospital Clinico Universitario de Valencia
RECRUITINGValencia, 46010, Spain
-
Hospital Clínico de Valladolid
RECRUITINGValladolid, Spain
-
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITINGMajadahonda, Spain
-
Israeli-Georgian Medical Research Clinical Helsicore
TERMINATEDTbilisi, Georgia, 0112, Georgia
-
Tbilisi Heart Centre
RECRUITINGTbilisi, Georgia, 0186, Georgia
-
Tbilisi Heart and Vascular Center
RECRUITINGTbilisi, Georgia, 0159, Georgia
-
Wroclaw University Hospital and Clinics
RECRUITINGWroclaw, 50-556, Poland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stick-On patch aims to catch dangerous heart decline sooner
- Blood test clues: could two proteins predict heart failure crises?
- Are heart failure patients taking their meds? a urine test at the ER aims to find out
- Can common heart drugs stay safe during a crisis? a trial investigates
- Heart failure fluid removal device trial halted early
- Massive new registry aims to unlock secrets of deadly heart shock