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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNephronyx LTD

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Patient with active DVT or history of DVT

Patient has documented or evidence of Renal artery stenosis

BMI>35 Kg/m²

Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization

Trial design

Treatments tested in this trial

  • Nephronyx system (Perfuser)

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators