Actively Recruiting
The Safety and Feasibility of the eLym™ System
Led by WhiteSwell, Limited · Updated on 2026-01-07
70
Participants Needed
11
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Safety and Feasibility of the eLym™ System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Hospitalized with a primary diagnosis of Acute Decompensated Heart Failure (ADHF)
- Receiving intravenous diuretics for fluid overload with peripheral edema 2+ or more and at least one of: jugular venous distension 10 cm H20 or more, pulmonary edema by exam or imaging, hepatojugular reflux, paroxysmal nocturnal dyspnea or two-pillow orthopnea, or dyspnea at rest with respiratory rate 20 or more
- Total daily diuretic dose prior to admission of 80 mg Lasix or equivalent
- Estimated glomerular filtration rate (eGFR) of 20 ml/min/1.73m2 or higher
- Meets one of the following: recent heart failure hospitalization or worsening requiring IV diuretics within 6 months; eGFR between 20 and 45 ml/min/1.73m2; urine output less than 600 ml within 6 hours of initial IV bolus or urine sodium less than 50 mmol/L 1-2 hours after initial IV diuretic dose
- Elevated NT Pro BNP (>1000 pg/ml, >1500 if atrial fibrillation) or BNP (>250 pg/ml, >375 if atrial fibrillation)
- Albumin level greater than 2.5 g/dL
- Able to have device placed within 96 hours of hospital presentation and still show fluid overload
- Willing and able to complete study assessments and follow-ups
- Provided written informed consent
You will not qualify if you...
- Anatomy not compatible with the eLym system device dimensions
- Need for intravenous vasoactive drugs, mechanical ventilation, mechanical circulatory support, or ultrafiltration
- Thromboembolic event (e.g., pulmonary embolism, deep vein thrombosis, TIA, stroke) within past 6 months
- Contraindications to systemic anticoagulation
- Currently taking Dabigatran
- International Normalized Ratio (INR) over 2.2 not due to anticoagulation therapy or hypercoagulable states
- Previous intracranial bleeding unless safe anticoagulation use documented
- Gastrointestinal bleeding within 6 months requiring hospital stay or transfusion
- Major surgery within 30 days with increased bleeding risk
- Platelet count below 75,000 per microliter
- Unable to tolerate anticoagulation therapy for 3 days
- Systolic blood pressure below 85 mmHg at enrollment
- Severe liver disease, liver fibrosis, or hepatorenal syndrome
- Active bloodstream infection or pneumonia
- Sustained malignant arrhythmias in last 90 days
- Acute coronary syndrome in last 3 months
- Severe other diseases likely to prolong hospitalization or cause death within 90 days
- Rhythm management device implanted within last 45 days
- Pregnant or lactating women; women of childbearing potential must have negative pregnancy test
- Physician discretion
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Israeli-Georgian Medical Research Clinical Helsicore
Tbilisi, Georgia, Georgia, 0112
Terminated
2
Tbilisi Heart and Vascular Center
Tbilisi, Georgia, Georgia, 0159
Actively Recruiting
3
Tbilisi Heart Centre
Tbilisi, Georgia, Georgia, 0186
Actively Recruiting
4
Wroclaw University Hospital and Clinics
Wroclaw, Poland, 50-556
Actively Recruiting
5
Hospital Clinic de Barcelona
Barcelona, Spain, Spain
Actively Recruiting
6
Germans Trias i Pujol Hospital
Badalona, Spain, 08916
Actively Recruiting
7
Hospital 12 de Octubre
Madrid, Spain
Actively Recruiting
8
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
Actively Recruiting
9
Hospital Clinico San Carlos
San Carlos, Spain
Actively Recruiting
10
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
11
Hospital Clínico de Valladolid
Valladolid, Spain
Actively Recruiting
Research Team
S
Sergio Shkurovich
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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