Reprieve System Pilot Study
The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure.
| Condition(s) | Acute Decompensated Heart Failure |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure. |
| Who can participate | Inclusion Criteria: 1. Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema/swelling) AND 1 sign (peripheral edema, ascites, jugular venous distension, pulmonary vascular congestion on chest radiography) 2. ≥10 lb. (4.5 kg) above dry weight either by historical weights or as estimated by health care provider. 3. 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 or other urologic issues that would predispose the patient to a high rate of urogenital trauma or infection with catheter placement. 2. Hemodynamic instability as defined by any of the following: systolic blood pressure \<90 mmHg, use of vasopress |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Reprieve Cardiovascular, Inc |
| Locations | Tbilisi, Georgia |
| Start date | 2024-01-23 |
| NCT ID | NCT06272734 |
| Official listing | https://clinicaltrials.gov/study/NCT06272734 |