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

Primary Purpose

Acute Decompensated Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Nephronyx system (Perfuser)
Sponsored by
Nephronyx LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Decompensated Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rambam Medical CenterRecruiting
  • The Baruch Padeh Medical Center, PoriyaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADHF patients

Arm Description

ADHF patients with compromised response to diuretics treated with Nephronyx system

Outcomes

Primary Outcome Measures

Serious Adverse Events
Device and/or investigational procedure related SAEs
Performance/ Procedural success
Device preforms as planned with no associated device malfunction

Secondary Outcome Measures

Full Information

First Posted
February 26, 2023
Last Updated
February 26, 2023
Sponsor
Nephronyx LTD
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1. Study Identification

Unique Protocol Identification Number
NCT05759806
Brief Title
Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
Official Title
Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nephronyx LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADHF patients
Arm Type
Experimental
Arm Description
ADHF patients with compromised response to diuretics treated with Nephronyx system
Intervention Type
Device
Intervention Name(s)
Nephronyx system (Perfuser)
Other Intervention Name(s)
The Nephronyx system (Perfuser)
Intervention Description
Temporary deployment of the Nephronyx system (Perfuser)
Primary Outcome Measure Information:
Title
Serious Adverse Events
Description
Device and/or investigational procedure related SAEs
Time Frame
24 hours post device retrieval
Title
Performance/ Procedural success
Description
Device preforms as planned with no associated device malfunction
Time Frame
procedure day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sagy Karavany
Phone
972-8-9999734
Email
sagy@nephronyx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doron Aronson, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Study Director
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Solomonica, MD
Email
a_solomonica@rambam.health.gov.il
Facility Name
The Baruch Padeh Medical Center, Poriya
City
Poriyya 'Illit
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wadi Kinany, MD
Email
WKinany@poria.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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