Clinical Trial

Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)

Study acronym: FASTR-II
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve System to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve System can more efficiently decongest ADHF patients in comparison to Control Therapy.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-03-25; most recent amendment 2025-11-24.
Status change: Not Yet Recruiting → Recruiting 2025-07-21
Trial Details
NCT Number NCT06898515
Lead Sponsor Reprieve Cardiovascular, Inc
Conditions Acute Decompensated Heart Failure
Enrollment 400 participants
Start Date 2025-07-14
Primary Completion 2027-08 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-11-26