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.

Study Overview

• Status: Recruiting
• Conditions: Acute Decompensated Heart Failure
• Intervention / Treatment: Device: Nephronyx system (Perfuser)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sagy Karavany; Phone Number: 972-8-9999734; Email: sagy@nephronyx.com

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Rambam Medical Center
    • Contact: Amir Solomonica, MD; Email: a_solomonica@rambam.health.gov.il
  • Jerusalem, Israel
    • Recruiting
    • Shaare Zedek Medical Center
    • Contact: Shemy Carasso, MD; Phone Number: +972-2-5645646; Email: shemyca@szmc.org.il
  • Poriyya 'Illit, Israel
    • Recruiting
    • The Baruch Padeh Medical Center, Poriya
    • Contact: Wadi Kinany, MD; Email: WKinany@poria.health.gov.il
  • Rehovot, Israel
    • Recruiting
    • Kaplan Medical Center
    • Contact: Sorel Goland, MD; Phone Number: +972-8-9440070; Email: Sorel_G@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADHF patients; ADHF patients with compromised response to diuretics treated with Nephronyx system	Device: Nephronyx system (Perfuser); Temporary deployment of the Nephronyx system (Perfuser); Other Names: The Nephronyx system (Perfuser)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Events	Device and/or investigational procedure related SAEs	24 hours post device retrieval
Performance/ Procedural success	Device preforms as planned with no associated device malfunction	procedure day

Collaborators and Investigators

• Sponsor: Nephronyx LTD
• Investigators: Study Director: Doron Aronson, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 26, 2023
• First Submitted That Met QC Criteria: February 26, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: CLD-NPX-085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No