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Lymph-Draining catheter could ease fluid overload in heart failure

NCT ID NCT05747196

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.

  1. The places running it

    10 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Badalona, 08916, Spain

  • Hospital 12 de Octubre

    RECRUITING

    Madrid, Spain

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, Spain, Spain

  • Hospital Clinico San Carlos

    RECRUITING

    San Carlos, Spain

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Clínico de Valladolid

    RECRUITING

    Valladolid, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    RECRUITING

    Majadahonda, Spain

  • Israeli-Georgian Medical Research Clinical Helsicore

    TERMINATED

    Tbilisi, Georgia, 0112, Georgia

  • Tbilisi Heart Centre

    RECRUITING

    Tbilisi, Georgia, 0186, Georgia

  • Tbilisi Heart and Vascular Center

    RECRUITING

    Tbilisi, Georgia, 0159, Georgia

  • Wroclaw University Hospital and Clinics

    RECRUITING

    Wroclaw, 50-556, Poland

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