Who may be eligible for this Acute Decompensated Heart Failure clinical trial?

Adults aged 18 years or older admitted with Acute Decompensated Heart Failure and receiving intravenous diuretics for fluid overload may be eligible. Participants must demonstrate ongoing fluid overload and meet certain kidney function and biomarker criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this Acute Decompensated Heart Failure clinical trial?

Study-related care, including the use of the WhiteSwell eLym System and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05747196

Evaluating the Safety and Use of the WhiteSwell eLym System to Remove Excess Fluid in Adults Hospitalized with Acute Decompensated Heart Failure

Q: What is the WhiteSwell eLym System studying for Acute Decompensated Heart Failure?

The WhiteSwell eLym System is being studied to evaluate its safety and how well it performs in reducing excess fluid in patients hospitalized with Acute Decompensated Heart Failure. The research focuses on device safety, treatment effectiveness, and patient outcomes during and after hospitalization.

Led by WhiteSwell, Limited · Updated on 2026-01-07

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and performance of the WhiteSwell eLym System for treating fluid overload or congestion in adults hospitalized with Acute Decompensated Heart Failure ADHF. This feasibility study focuses on assessing both acute and chronic device safety, as well as the technical success and patient treatment outcomes related to this device. The WhiteSwell eLym System is a device designed to reduce congestion by creating a low-pressure zone at the thoracic duct outflow, which helps move fluid from the lymphatic system back into the bloodstream. The device consists of a catheter and sheath used with a console and is temporarily placed for up to 60 hours via the left internal jugular vein while patients continue receiving intravenous diuretics. This treatment occurs during hospitalization, with the device placed in a heart catheterization laboratory. Participants will be monitored during their hospital stay and followed up at 30, 60, 90, and 180 days after discharge. Researchers will assess safety by tracking serious adverse events related to the device and treatment, technical success of device placement and removal, as well as changes in body weight, fluid levels, kidney function, lung water, and heart failure therapy needs. Additionally, quality of life and biomarker levels will be evaluated to understand long-term outcomes, including the time to rehospitalization for heart failure.

CONDITIONS

Brief Title

The Safety and Feasibility of the eLym™ System

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Hospitalized with primary diagnosis of Acute Decompensated Heart Failure
Receiving intravenous diuretics for fluid overload with peripheral edema 2+ or higher
Presence of at least one symptom such as jugular venous distension, pulmonary edema, hepatojugular reflux, paroxysmal nocturnal dyspnea or orthopnea, or dyspnea at rest
Total daily diuretic dose prior to admission of 80 mg Lasix or equivalent
Estimated glomerular filtration rate (eGFR) 20 ml/min/1.73m2 or higher
Meet one of the following: recent heart failure hospitalization or worsening event within 6 months, eGFR between 20 and 45 ml/min/1.73m2, or low urine output or urine sodium after initial diuretic dose
Elevated NT-ProBNP or BNP levels above specified thresholds
Albumin level above 2.5 g/dL
Able to have device placement within 96 hours of hospital presentation with ongoing fluid overload
Willing and able to complete study assessments and follow-up
Provided written informed consent

You will not qualify if you...

Anatomy incompatible with device dimensions
Need for intravenous vasoactive therapies, mechanical ventilation, mechanical circulatory support, or ultrafiltration
Thromboembolic event (e.g., pulmonary embolism, deep vein thrombosis, stroke) within past 6 months
Contraindications to systemic anticoagulation
Current use of Dabigatran
International Normalized Ratio (INR) above 2.2 not related to anticoagulation or inability to withhold certain anticoagulants before device placement
Previous intracranial bleed without safe anticoagulation documentation
Gastrointestinal bleeding requiring hospitalization or transfusion within 6 months
Recent major surgery within 30 days with bleeding risk
Platelet count below 75,000 per microliter
Inability to tolerate anticoagulation for up to 3 days
Systolic blood pressure below 85 mmHg at enrollment
Severe liver disease or hepatorenal syndrome
Active bloodstream infection or pneumonia
Sustained malignant arrhythmias in past 90 days
Acute coronary syndrome in past 3 months
Severe concomitant disease expected to shorten life or prolong hospitalization
Recent rhythm management device implantation within 45 days
Pregnancy or lactation; women of childbearing potential must have negative pregnancy test
Physician discretion

Research Team

Sergio Shkurovich

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Evaluating the Safety and Use of the WhiteSwell eLym System to Remove Excess Fluid in Adults Hospitalized with Acute Decompensated Heart Failure

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria