Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
NCT ID: NCT05759806
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2022-12-19
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ADHF patients
ADHF patients with compromised response to diuretics treated with Nephronyx system
Nephronyx system (Perfuser)
Temporary deployment of the Nephronyx system (Perfuser)
Interventions
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Nephronyx system (Perfuser)
Temporary deployment of the Nephronyx system (Perfuser)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Nephronyx LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Doron Aronson, MD
Role: STUDY_DIRECTOR
Rambam Health Care Campus
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CLD-NPX-085
Identifier Type: -
Identifier Source: org_study_id
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