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RECRUITING
NCT06272734
NA

Reprieve System Pilot Study

Sponsor: Reprieve Cardiovascular, Inc

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-01-23

Completion Date

2026-12-31

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

DEVICE

Reprieve 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.

Locations (1)

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia