Status: Recruiting
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 efficiently decongest ADHF patients in comparison to Control Therapy.
Participants needed: 400
Trial details
Age: 22+Biological sex: AllType: InterventionalSponsor: Reprieve Cardiovascular, IncUpdated: Oct 13, 2026Locations: 50
Eligibility criteria
Diagnosis of HF with expected hospitalization >24 hours, with >1 new or worsenin... [+4]
Urologic issues that would predispose the participant to a high rate of urogenit... [+12]