Acute Decompensated Heart Failure
Conditions
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.
Interventions
DEVICENephronyx system (Perfuser)
Temporary deployment of the Nephronyx system (Perfuser)
Sponsors
Nephronyx LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Israel
Contacts
Primary ContactSagy Karavany
Outcome results
None listed