RecruitingNot ApplicableNCT06272734

Reprieve System Pilot Study

Reprieve System for the Treatment of Subjects With Acute Decompensated Heart Failure Pilot Study

Sponsor

Reprieve Cardiovascular, Inc

Enrollment

50 participants

Start Date

Jan 23, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Decompensated Heart Failure

Summary

The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the Reprieve System, a device designed to improve urine output (diuresis) in people hospitalized with heart failure who are retaining fluid. The device works by regulating fluid removal through a urinary catheter in combination with IV fluids. **You may be eligible if...** - You are 18 or older - You are hospitalized with a diagnosis of heart failure - You are retaining significant fluid — at least 10 pounds above your normal body weight - You are able to give informed consent **You may NOT be eligible if...** - You cannot have a urinary catheter placed safely - You have hemodynamic instability (your blood pressure is too unstable) - You have severe kidney disease or other conditions that make the device unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEReprieve System

The study is broken into stages: 1. In Stage one, Subjects enrolled in the study received Reprieve System (RS) therapy, a hospital bedside fluid management system designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure. (complete, N=10) 2. In future Stages, Subjects enrolled in the study will receive RS therapy and will be given varying levels of water consumption to challenge the algorithm. Future Stages will also assess new RS hardware and software features.