Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF

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 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