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Reprieve System Pilot Study

NCT06272734 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-05

No results posted yet for this study

Summary

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

Conditions

  • Acute Decompensated Heart Failure

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.

Sponsors & Collaborators

  • Reprieve Cardiovascular, Inc

    lead INDUSTRY

Principal Investigators

  • Tamaz Shaburishvili, MD · Tbilisi Heart and Vascular Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • Georgia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06272734 on ClinicalTrials.gov