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โ† Trials
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Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF

RecruitingNAAges 18 Years - anyAllNephronyx LTD
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 \> 38ยฐC, or sepsis, or active systemic infection requiring IV anti-microbial treatment * Patient has shown liver cirrhosis or has signs of liver damage
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What it tests

  • Nephronyx system (Perfuser)
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Where

4 sites
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
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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