Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-02-28
2026-12-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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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.
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 the interstitial compartment through the lymphatic system and the Thoracic Duct and into the intravascular space, while removal of fluids from the intravascular space is enabled using diuretic therapy. The treatment duration will be up to 72 hours.
Interventions
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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 the interstitial compartment through the lymphatic system and the Thoracic Duct and into the intravascular space, while removal of fluids from the intravascular space is enabled using diuretic therapy. The treatment duration will be up to 72 hours.
Eligibility Criteria
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Inclusion Criteria
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
* Subjects have anatomical abnormalities that would affect the insertion and deployment of the eLym System
* Subject has vein diameters at anticipated sites of deployment balloons that are not within the following specifications:
* Proximal restriction balloon site must have a venous diameter of 8 - 18 millimeters (mm)
* Distal balloon site must have a diameter of 12 - 20 mm
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
18 Years
ALL
No
Sponsors
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WhiteSwell, Limited
INDUSTRY
Responsible Party
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Principal Investigators
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William Abraham, MD
Role: STUDY_DIRECTOR
Ohio State University
Locations
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Israeli-Georgian Medical Research Clinical Helsicore
Tbilisi, Georgia, Georgia
Tbilisi Heart and Vascular Center
Tbilisi, Georgia, Georgia
Tbilisi Heart Centre
Tbilisi, Georgia, Georgia
Wroclaw University Hospital and Clinics
Wroclaw, , Poland
Hospital Clinic de Barcelona
Barcelona, Spain, Spain
Germans Trias i Pujol Hospital
Badalona, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Clínico de Valladolid
Valladolid, , Spain
Countries
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Central Contacts
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Facility Contacts
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George Khabeishvili, MD
Role: primary
Archil Chukhrukidze, MD
Role: primary
Jan Biegus, MD
Role: primary
Aleksandra Szygula
Role: backup
Paula Cayuela Villanueva
Role: primary
Antoni Bayes-Genis, MD
Role: primary
Paloma Gastelurrutia
Role: backup
Esther Meruś
Role: primary
María del Trigo, MD, PhD
Role: primary
Iraxte Goicolea
Role: backup
Julio Nunez Villota, MD
Role: primary
Anna Mollar
Role: backup
Carlos Baladrón
Role: primary
References
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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.
Other Identifiers
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DELTA-HF CIP-01
Identifier Type: -
Identifier Source: org_study_id