NCT06272734

Reprieve System Pilot Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Reprieve Cardiovascular, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-01-23
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-02-22
• Last updated: 2026-02-05

Locations

1 site across 1 country: Georgia

Regulatory

• FDA-regulated device study