Condition: Heart; Decompensation, Congestive · Sponsor: WhiteSwell, Limited
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.
This description comes directly from the study's public registry record.
Sergio Shkurovich · +1(818)207-7743 · sergio@whiteswell.com
Always discuss trial participation with your own doctor first.
| Israeli-Georgian Medical Research Clinical Helsicore | Tbilisi, Georgia, Georgia | Terminated |
| Tbilisi Heart and Vascular Center | Tbilisi, Georgia, Georgia | Recruiting |
| Tbilisi Heart Centre | Tbilisi, Georgia, Georgia | Recruiting |
| Wroclaw University Hospital and Clinics | Wroclaw, Poland | Recruiting |
| Hospital Clinic de Barcelona | Barcelona, Spain, Spain | Recruiting |
| Germans Trias i Pujol Hospital | Badalona, Spain | Recruiting |
| Hospital 12 de Octubre | Madrid, Spain | Recruiting |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda, Spain | Recruiting |
| Hospital Clinico San Carlos | San Carlos, Spain | Recruiting |
| Hospital Clinico Universitario de Valencia | Valencia, Spain | Recruiting |
| Hospital Clínico de Valladolid | Valladolid, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05747196