Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
1 other identifier
interventional
10
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2022
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2022
CompletedFirst Submitted
Initial submission to the registry
February 26, 2023
CompletedFirst Posted
Study publicly available on registry
March 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedMay 25, 2025
May 1, 2025
3.5 years
February 26, 2023
May 21, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
ADHF patients
EXPERIMENTALADHF patients with compromised response to diuretics treated with Nephronyx system
Interventions
Temporary deployment of the Nephronyx system (Perfuser)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nephronyx LTDlead
Study Sites (4)
Rambam Medical Center
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
The Baruch Padeh Medical Center, Poriya
Poria Illit, Israel
Kaplan Medical Center
Rehovot, Israel
Study Officials
- STUDY DIRECTOR
Doron Aronson, MD
Rambam Health Care Campus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2023
First Posted
March 8, 2023
Study Start
December 19, 2022
Primary Completion
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
May 25, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share