The Safety and Feasibility of the eLym™ System
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 saf
| Condition(s) | Heart; Decompensation, Congestive |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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). 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. |
| Who can participate | 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 on |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | WhiteSwell, Limited |
| Locations | Tbilisi, Georgia, Georgia; Tbilisi, Georgia, Georgia; Tbilisi, Georgia, Georgia; Wroclaw, Poland; Barcelona, Spain, Spain; Badalona, Spain (+5 more sites) |
| Start date | 2023-02-28 |
| NCT ID | NCT05747196 |
| Official listing | https://clinicaltrials.gov/study/NCT05747196 |