Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADHF patients | Experimental | ADHF patients with compromised response to diuretics treated with Nephronyx system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nephronyx system (Perfuser) | Device | Temporary deployment of the Nephronyx system (Perfuser) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | Device and/or investigational procedure related SAEs | 24 hours post device retrieval |
| Performance/ Procedural success | Device preforms as planned with no associated device malfunction | procedure day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sagy Karavany | Contact | 972-8-9999734 | sagy@nephronyx.com |
| Name | Affiliation | Role |
|---|---|---|
| Doron Aronson, MD | Rambam Health Care Campus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical Center | Recruiting | Haifa | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Shaare Zedek Medical Center | Recruiting | Jerusalem | Israel |
|
| The Baruch Padeh Medical Center, Poriya | Recruiting | Poria Illit | Israel |
|
| Kaplan Medical Center | Recruiting | Rehovot | Israel |
|