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NCT06898515 · ClinicalTrials.gov registry record · Phase 3
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
A Phase 3 study of Acute Decompensated Heart Failure, sponsored by Reprieve Cardiovascular.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT06898515: Recruiting Phase 3 study of Acute Decompensated Heart Failure, sponsored by Reprieve Cardiovascular.
NCT06898515 is a Phase 3 study of Acute Decompensated Heart Failure that is actively recruiting participants, run by Reprieve Cardiovascular. The registered enrollment target is 400 participants, roughly in line with the 426-participant average among 12 other Acute Decompensated Heart Failure trials with a reported enrollment target. The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06898515, a Phase 3 study of Acute Decompensated Heart Failure, is actively recruiting participants, sponsored by Reprieve Cardiovascular.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
1. Freedom from 30-day CV mortality 2. Freedom from HF Rehospitalization 30 days post-discharge 3. Greater net sodium loss per 24 hours during treatment
Conditions Studied
Interventions
- DEVICE Reprieve System
- DRUG furosemide infusion
Study Locations (20)
California
- University of California Irvine - Irvine
- Scripps Memorial Hospital - La Jolla
- UC Davis Medical Center - Sacramento
Georgia
- Piedmont Atlanta Hospital - Atlanta
- Piedmont Augusta Hospital - Augusta
- Northeast Georgia Medical Center - Gainesville
Michigan
- Trinity Health Ann Arbor Hospital - Ann Arbor
- Corewell Health Butterworth Hospital - Grand Rapids
- Corewell William Beaumont University Hospital - Royal Oak
Missouri
- Harry S. Truman Veteran's Memorial Hospital - Columbia
- St. Louis VA - St Louis
- Washington University - St Louis
Florida
- University of Florida - Gainesville
Illinois
- Advocate Christ Medical Center - Oak Lawn
Kansas
- University of Kansas Medical Center - Kansas City
Kentucky
- University of Louisville Hospital - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2025-07-14 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
What NCT06898515 shows while recruiting
NCT06898515 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 426-participant average among 12 other Acute Decompensated Heart Failure trials with a reported enrollment target.
The record links to 1 condition, with Acute Decompensated Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Reprieve System is the first listed.
NCT06898515 names 20 study sites across 12 states, led by California, Georgia, Michigan.
Frequently Asked Questions
What is clinical trial NCT06898515 about?
NCT06898515 is a clinical study titled "Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)". 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 ...
What is the current status of trial NCT06898515?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2025-07-14. Estimated completion is 2027-12.
What conditions does trial NCT06898515 study?
This clinical trial studies the following conditions: Acute Decompensated Heart Failure.
What interventions are being tested in trial NCT06898515?
The interventions under investigation include: Reprieve System (DEVICE), furosemide infusion (DRUG).
Who is sponsoring clinical trial NCT06898515?
This trial is sponsored by Reprieve Cardiovascular, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06898515 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06898515's enrollment target sits among peer trials
400 6th of 12 higher than 7 of 12 other Acute Decompensated Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Decompensated Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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