Heart Failure
Conditions
Brief summary
Reprieve Cardiovascular System for the Treatment of Subjects with Acute Decompensated Heart Failure Mechanistic Study
Detailed description
The key objective of the trial was to provide an optimized decongestion treatment for subjects with acute decompensated heart failure and identify the critical parameters that could be incorporated into the design of the next generation of the Reprieve Cardiovascular System.
Interventions
OTHERFluid Management
Removal of excess extracellular fluid using diuretics
System with Fluid Management Module
Sponsors
Reprieve Cardiovascular, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hospitalized with a diagnosis of heart failure 2. Patients ≥ 18 years of age able to provide informed consent and comply with study procedures.
Exclusion criteria
1. Inability to place Foley catheter or IV catheter 2. Hemodynamic instability 3. Dyspnea due primarily to non-cardiac causes 4. Acute infection with evidence of systemic involvement 5. Inability to follow instructions or comply with follow-up procedures. 6. Other concomitant disease or condition that investigator deems unsuitable for the study 7. Enrollment in another interventional trial during the index hospitalization 8. Life expectancy less than 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device and Procedure related AEs and SAEs | Through study completion, an average of 90 days | Rate of device and procedure related AEs and SAEs |
| Fractional Excretion of Sodium measured during therapy | End of treatment, an average of 24 hours | Average fractional excretion of sodium across all patients measured during therapy |
Countries
Georgia
Outcome results
None listed