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

Not Applicable

Recruiting

• Conditions: Acute Decompensated Heart Failure
• Interventions: Device: Nephronyx system (Perfuser)

• Registration Number: NCT05759806
• Lead Sponsor: Nephronyx LTD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-19
• Study First Submitted: 2023-02-26
• Study First Submitted QC: 2023-02-26
• Study First Posted: 2023-03-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADHF patients	Nephronyx system (Perfuser)	ADHF patients with compromised response to diuretics treated with Nephronyx system

Primary Outcome Measures

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

Trial Locations

Locations (2)

Rambam Medical Center; 🇮🇱 Haifa, Israel

The Baruch Padeh Medical Center, Poriya; 🇮🇱 Poriyya 'Illit, Israel