Actively Recruiting
Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
Led by Nephronyx LTD · Updated on 2025-05-25
10
Participants Needed
4
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient admitted to the hospital with a primary diagnosis of ADHF
- Patient has signs of volume overload as evidence by a score of 2424 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
You will not qualify if you...
- Patient with active DVT or history of DVT
- Patient has documented or evidence of Renal artery stenosis
- BMI >35 Kg/m^2
- Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization
- Patient is in Cardiogenic shock
- Patient has blood dyscrasia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy
- Temperature > 38 0C, or sepsis, or active systemic infection requiring IV anti-microbial treatment
- Patient has shown liver cirrhosis or has signs of liver damage
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Rambam Medical Center
Haifa, Israel
Actively Recruiting
2
Shaare Zedek Medical Center
Jerusalem, Israel
Actively Recruiting
3
The Baruch Padeh Medical Center, Poriya
Poria Illit, Israel
Actively Recruiting
4
Kaplan Medical Center
Rehovot, Israel
Actively Recruiting
Research Team
S
Sagy Karavany
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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