Evaluating Safety and Effectiveness of the Nephronyx Device for Adults With Acute Decompensated Heart Failure Who Do Not Respond Well to Diuretics

What this Trial Is About

Researchers are evaluating the safety and functional performance of the Nephronyx System in patients with Acute Decompensated Heart Failure ADHF who show signs of excess fluid buildup and have a reduced response to diuretics. This interventional study focuses on patients admitted to the hospital with these specific heart failure conditions to understand how well the device works and how safe it is to use. The study involves temporarily deploying the Nephronyx system Perfuser in patients who have compromised responses to diuretics. These patients will be treated with the device during their hospital stay. The main outcomes measured include serious adverse events within 24 hours after the device is removed and the success of the procedure on the day it is performed. Participants will be closely monitored during and after the procedure, with assessments focusing on safety and the devices performance. Researchers will track any serious side effects shortly after the device is taken out and evaluate how effectively the device manages the patients condition during the procedure. The study is expected to continue until July 2026, with participants involved for the duration of their hospital treatment and immediate follow-up period.

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