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

Acute Decompensated Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759806
• Other study ID #: CLD-NPX-085
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Nephronyx LTD
• Contact: Sagy Karavany
• Phone: 972-8-9999734
• Email: sagy[@]nephronyx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa
Israel	The Baruch Padeh Medical Center, Poriya	Poriyya 'Illit

Sponsors (1)

Lead Sponsor	Collaborator
Nephronyx LTD

Country where clinical trial is conducted

Israel, 

Outcome

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