Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
Acute Decompensated Heart Failure
About this trial
This is an interventional treatment trial for Acute Decompensated Heart Failure
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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°C, or sepsis, or active systemic infection requiring IV anti-microbial treatment Patient has shown liver cirrhosis or has signs of liver damage
Sites / Locations
- Rambam Medical CenterRecruiting
- The Baruch Padeh Medical Center, PoriyaRecruiting
Arms of the Study
Arm 1
Experimental
ADHF patients
ADHF patients with compromised response to diuretics treated with Nephronyx system