Tests the Nephronyx device for acute decompensated heart failure
Tests the Nephronyx device in adults with sudden worsening heart failure and fluid buildup.
Plain-language title generated from the registry record
Registry title: Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
Key facts
- Where
- Haifa, Jerusalem, Poria Illit, and Rehovot, IsraelSee the 4 sites
Where in Israel
- Rambam Medical CenterHaifa, IsraelTaking people
- Shaare Zedek Medical CenterJerusalem, IsraelTaking people
- The Baruch Padeh Medical Center, PoriyaPoria Illit, IsraelTaking people
- Kaplan Medical CenterRehovot, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nephronyx LTD
- Trial code
- NCT05759806
- Record updated
- 25 May 2025
- Original description
The objective of this interventional study is to evaluate the safety and functional performance of the Nephronyx System in patients with ADHF, presenting clinical signs of volume overload and compromised response to diuretics.Read full original descriptionShow less
Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
The objective of this interventional study is to evaluate the safety and functional performance of the Nephronyx System in patients with ADHF, presenting clinical signs of volume overload and compromised response to diuretics.
Inclusion: Patient admitted to the hospital with a primary diagnosis of ADHF; Patient has signs of volume overload as evidence by a score of ≥ 4 on the EVEREST score; Patient with Left Ventricular Ejection Fraction LVEF >15%; Patient has compromised response to diuretics; NT-proBNP >450 pg/mL if aged <55 years, >900 pg/mL if aged between 55 and 75 years and >1800 pg/mL if aged >75 years.
Exclusion: Patient with active DVT or history of DVT; Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization; Patient has blood dyscrasia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy; Temperature > 38°C, or sepsis, or active systemic infection requiring IV anti-microbial treatment; Patient has documented or evidence of Renal artery stenosis; BMI>35 Kg/m\^2; Patient is in Cardiogenic shock; Patient has shown liver cirrhosis or has signs of liver damage.