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

Study acronym: FASTR-II
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 2 of 2 entries Trial sites reduced: 53 → 50 locations · Secondary endpoints: details revised at 3 of 11 entries · Eligibility criteria shortened, about 2 words Show 3 more changesShow less
    • Trial sites reduced: 53 → 50 locations
    • Secondary endpoints: details revised at 3 of 11 entries
    • Eligibility criteria shortened, about 2 words
  2. Study sites: 27 to 53v6
  3. Primary endpoints: 1 to 2 Study sites: 12 to 27 · Secondary endpoints: 10 to 11v5 Show 2 more changesShow less
    • Study sites: 12 to 27
    • Secondary endpoints: 10 to 11

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 11 to 12v4
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 2025 to Jul 14, 2025 · Site details revised at 11 of 11 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of May 2025 to Jul 14, 2025
    • Site details revised at 11 of 11 sites
  6. Study title expanded, about 1 wordv2 See this version in full on ClinicalTrials.gov ↗
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06898515
Lead Sponsor Reprieve Cardiovascular, Inc
Conditions Acute Decompensated Heart Failure
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov