Heart; Decompensation, CongestiveDELTA-HFNCT05747196
The Safety and Feasibility of the eLym™ System
A study testing WhiteSwell eLym System in people with Heart; Decompensation, Congestive, run by WhiteSwell, Limited at 11 sites in 3 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart; Decompensation, Congestive
- What is being tested?
- WhiteSwell eLym System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 28 Feb 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 21Show fewer
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 3 countries
Spain7 sites, 7 recruiting
- Recruiting
Germans Trias i Pujol Hospital
Badalona, 08916
Antoni Bayes-Genis, MD, +34 934978915, abayesgenis@gmail.com
Paloma Gastelurrutia, +34 930330521, pgastelurrutia@gmail.com
- Recruiting
Hospital Clinic de Barcelona
Barcelona, Spain
Paula Cayuela Villanueva, +34 932275400 ext. 2912, pacayuela@recerca.clinic.cat
Omar Abdul-Jawad Altisent
- Recruiting
Hospital 12 de Octubre
Madrid
Esther Meruś, +34 917792642 ext. 4642, estermelus.imas12@h12o.es
María Dolores García-Cosío
- Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
María del Trigo, MD, PhD, +34 615138264, mariadeltrigo@hotmail.com
Iraxte Goicolea, +34 618095486, iraxte.goicolea@gmail.com
- Recruiting
Hospital Clinico San Carlos
San Carlos
Lucía Rodríguez Vázquez, 913303000, lrvazquez.externo@salud.madrid.org
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Julio Nunez Villota, MD, +34 961973520, yulnunez@gmail.com
Anna Mollar, +34 961973520, annam.mollar@gmail.com
- Recruiting
Hospital Clínico de Valladolid
Valladolid
Carlos Baladrón, +34 644144282, cblazor@gmail.com
Ignacio Amat
Georgia3 sites, 2 recruiting
- Terminated
Israeli-Georgian Medical Research Clinical Helsicore
Tbilisi, Georgia, 0112
- Recruiting
Tbilisi Heart and Vascular Center
Tbilisi, Georgia, 0159
George Khabeishvili, MD, georgekhabeishvili@me.com
George Khabeishvili, MD
- Recruiting
Tbilisi Heart Centre
Tbilisi, Georgia, 0186
Archil Chukhrukidze, MD, achidoc@gmail.com
Archil Chukhrukidze, MD
Poland1 site, 1 recruiting
- Recruiting
Wroclaw University Hospital and Clinics
Wroclaw, 50-556
Jan Biegus, MD, jan.biegus@umw.edu.pl
Aleksandra Szygula, +48 881 940 944, szygulaleksandra@gmail.com
About this study
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
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.
- Conditions
- Heart; Decompensation, Congestive
- Being tested
- WhiteSwell eLym System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WhiteSwell eLym SystemDevice
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 60 hours.
| Study group | Role | What they receive |
|---|---|---|
| Open Label Treatment Arm | Experimental | 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 60 hours. Receives: Device: WhiteSwell eLym System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute safety as assessed by the rate of acute adjudicated device-, treatment-, and procedure-related Serious Adverse Events
The rate of acute device-, treatment-, and procedure-related Serious Adverse Events (SAE) as adjudicated by an independent Clinical Events Committee will be reported.
Measured: 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)
The rate of chronic device-, treatment-, and procedure-related Serious Adverse Events (SAE) as adjudicated by an independent Clinical Events Committee will be reported.
Measured: 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.
The system's technical performance will be assessed by evaluating the rate of procedures in which the user is able to deploy, activate and remove the system.
Measured: 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
Patients' acute response to therapy will be evaluated by assessing changes in body weight as measured in kilograms at 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). The change in weight will be expressed as an absolute change and percent change with an expected decrease corresponding to a treatment response.
Measured: 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)
Patients' acute response to therapy will be evaluated by assessing changes in patients' net fluid loss or gain based in total intake and output over 24 hours and expressed in milliliters at 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). An expected net fluid loss would correspond to a treatment response.
Measured: 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)
Patients' acute response to therapy will be evaluated by assessing changes in renal function as measured by estimated glomerular filtration rate (eGFR) (ml/min/1.73 (2)) using the Modification of Diet in Renal Disease (MDRD) calculation. Stable renal function would indicate a neutral response to therapy.
Measured: 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
Patients' acute response to therapy will be evaluated by assessing changes in renal function as measured by changes in serum creatinine (mg/dL). Stable renal function would indicate a neutral response to therapy.
Measured: 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
Patients' acute response to therapy will be evaluated by assessing the need for intensified heart failure therapies indicating a worsening of the patient's condition, specifically evaluating the use of mechanical circulatory support, intravenous inotropes, or intravenous venodilators.
Measured: 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.
Patients' acute response to therapy will be evaluated by assessing Extra Vascular Lung Water (EVLW) as measured by Sensible Medical ReDS technology. The digital readout is provide as percent (%) with increasing numbers indicating a higher percentage of lung water and more congestion. Normal is consider to be less than 30%. Assessments will be made on seated patients prior to and just after the completion of therapy (less than or equal to 72 hours after the initiation of therapy).
Measured: 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).
Changes in patients' quality of life will be assessed based on responses to the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. All items are measured on a Likert scale with 5-7 response options. All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent. The scale will be administered at baseline, hospital discharge, and 30- 90- and 180- days post discharge.
Measured: Baseline, Hospital discharge (typically 3- 10 days post hospital admission), 30-, 90-, and 180-days after hospital discharge.
Chronic response to therapy as evaluated by assessing changes in N Terminal-Pro Brain Natriuretic Peptide (NT-ProBNP) or Brain Natriuretic Peptide (BNP) biomarker levels
Changes in N Terminal Pro Brain Natriuretic Peptide in picograms/milliliter (pg/ml) (NT-ProBNP) or Brain Naturiretic Peptide picograms/milliliter (pg/ml)(BNP) will assessed to evaluate the patient heart failure status at baseline, 30-, 90- and 180- days. NT-ProBNP or BNP increases are noted with increased patient congestion. A reduction in NT-ProBNP or BNP would indicate a patient improvement. Changes in NT-ProBNP or BNP will be expressed as an absolute change and a percent change from baseline.
Measured: Baseline and 30-, 90-, and 180-days after hospital discharge
Long term patient outcomes as evaluated by the time (days) to rehospitalization for acute decompensated heart failure
Patients' need for rehospitalization for acute decompensated heart failure will be reported as observed starting at hospital discharge post therapy through the 180-day follow up window. An independent clinical events committee will adjudicate hospitalizations for heart failure relatedness.
Measured: Hospital discharge through 180 days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start28 Feb 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart; Decompensation, CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study protocol indicates that subjects signing consent will be "enrolled"; however, the number of subjects treated with the investigational device will be less due to screening for inclusion / exclusion criteria.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WhiteSwell, Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Abraham, MD, Study director, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747196
- Sponsor's protocol ID
- DELTA-HF CIP-01
- Acronym
- DELTA-HF
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39716986
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05747196
- Acronym / sponsor ID
- DELTA-HF / DELTA-HF CIP-01
- Conditions
- Heart; Decompensation, Congestive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- WhiteSwell, LimitedIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study protocol indicates that subjects signing consent will be "enrolled"; however, the number of subjects treated with the investigational device will be less due to screening for inclusion / exclusion criteria.
| Arm | Type | Receives |
|---|---|---|
| Open Label Treatment Arm | Experimental | Device: WhiteSwell eLym SystemHospitalized 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 60 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- 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
Key exclusion criteria (21 listed)
- Ultrasound Screening Assessment Exclusion:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WhiteSwell eLym SystemThe 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 60 hours. | Device | Open Label Treatment Arm |
Primary outcome
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
The rate of acute device-, treatment-, and procedure-related Serious Adverse Events (SAE) as adjudicated by an independent Clinical Events Committee will be reported.
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
The rate of chronic device-, treatment-, and procedure-related Serious Adverse Events (SAE) as adjudicated by an independent Clinical Events Committee will be reported.
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)
The system's technical performance will be assessed by evaluating the rate of procedures in which the user is able to deploy, activate and remove the system.
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)
Patients' acute response to therapy will be evaluated by assessing changes in body weight as measured in kilograms at 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). The change in weight will be expressed as an absolute change and percent change with an expected decrease corresponding to a treatment response.
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)
Patients' acute response to therapy will be evaluated by assessing changes in patients' net fluid loss or gain based in total intake and output over 24 hours and expressed in milliliters at 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). An expected net fluid loss would correspond to a treatment response.
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
Patients' acute response to therapy will be evaluated by assessing changes in renal function as measured by estimated glomerular filtration rate (eGFR) (ml/min/1.73 (2)) using the Modification of Diet in Renal Disease (MDRD) calculation. Stable renal function would indicate a neutral response to therapy.
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
Patients' acute response to therapy will be evaluated by assessing changes in renal function as measured by changes in serum creatinine (mg/dL). Stable renal function would indicate a neutral response to therapy.
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)
Patients' acute response to therapy will be evaluated by assessing the need for intensified heart failure therapies indicating a worsening of the patient's condition, specifically evaluating the use of mechanical circulatory support, intravenous inotropes, or intravenous venodilators.
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)
Patients' acute response to therapy will be evaluated by assessing Extra Vascular Lung Water (EVLW) as measured by Sensible Medical ReDS technology. The digital readout is provide as percent (%) with increasing numbers indicating a higher percentage of lung water and more congestion. Normal is consider to be less than 30%. Assessments will be made on seated patients prior to and just after the completion of 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.
Changes in patients' quality of life will be assessed based on responses to the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. All items are measured on a Likert scale with 5-7 response options. All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent. The scale will be administered at baseline, hospital discharge, and 30- 90- and 180- days post discharge.
Chronic response to therapy as evaluated by assessing changes in N Terminal-Pro Brain Natriuretic Peptide (NT-ProBNP) or Brain Natriuretic Peptide (BNP) biomarker levels
Time frame: Baseline and 30-, 90-, and 180-days after hospital discharge
Changes in N Terminal Pro Brain Natriuretic Peptide in picograms/milliliter (pg/ml) (NT-ProBNP) or Brain Naturiretic Peptide picograms/milliliter (pg/ml)(BNP) will assessed to evaluate the patient heart failure status at baseline, 30-, 90- and 180- days. NT-ProBNP or BNP increases are noted with increased patient congestion. A reduction in NT-ProBNP or BNP would indicate a patient improvement. Changes in NT-ProBNP or BNP will be expressed as an absolute change and a percent change from baseline.
Long term patient outcomes as evaluated by the time (days) to rehospitalization for acute decompensated heart failure
Time frame: Hospital discharge through 180 days post hospital discharge
Patients' need for rehospitalization for acute decompensated heart failure will be reported as observed starting at hospital discharge post therapy through the 180-day follow up window. An independent clinical events committee will adjudicate hospitalizations for heart failure relatedness.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Derived from this study: PubMed 39716986Biegus 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.
- Individual participant dataSharing planned: No
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The FOCUS-ADHF Registry
Acute Heart Failure With Reduced Ejection Fraction, Decompensation; Heart, Congestive
RecruitingObservational study
Prediction of Heart-Failure with Machine Learning
Heart Failure with Reduced Ejection Fraction, Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Abraham, MD study director
Ohio State University
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WhiteSwell eLym System in people with Heart; Decompensation, Congestive, run by WhiteSwell, Limited at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, Georgia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergio Shkurovich (+1(818)207-7743, sergio@whiteswell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05747196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.