RecruitingNot ApplicableNCT05759806

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

Sponsor

Nephronyx LTD

Enrollment

10 participants

Start Date

Dec 19, 2022

Study Type

INTERVENTIONAL

Conditions

Acute Decompensated Heart Failure

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria8

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