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Recruiting NCT05759806

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

No phase Interventional Acute Decompensated Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nephronyx system (Perfuser).
Who it may be relevant to
Registry conditions: Acute Decompensated Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Nephronyx system (Perfuser)
    Temporary deployment of the Nephronyx system (Perfuser)

Primary outcome measures

  • Serious Adverse Events [Time frame: 24 hours post device retrieval]
  • Performance/ Procedural success [Time frame: procedure day]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 4 centers
  • Rambam Medical Center — Haifa
  • Shaare Zedek Medical Center — Jerusalem
  • The Baruch Padeh Medical Center, Poriya — Poria Illit
  • Kaplan Medical Center — Rehovot

Identifiers

NCT: NCT05759806 · CLD-NPX-085

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗