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

Nephronyx

Status

Enrolling

Conditions

Acute Decompensated Heart Failure

Treatments

Device: Nephronyx system (Perfuser)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05759806

CLD-NPX-085

Details and patient eligibility

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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