NCT06272734Recruiting
Reprieve System Pilot Study
Reprieve System for the Treatment of Subjects With Acute Decompensated Heart Failure Pilot Study
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 15 Feb 2024
- Start date
- 23 Jan 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Reprieve Cardiovascular, Inc
- Diseases
- Heart failure
- NCT number
- NCT06272734
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 23 Jan 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Significant left ventricular outflow obstruction, uncorrected complex congenital heart disease, known severe stenotic valvular disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiring treatment (within previous week), or any other pathology that, in the opinion of the investigator, would make aggressive diuresis poorly tolerated.
- Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral, or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the protocol instructions or follow-up procedures.
Other illness
- 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.
- Hemodynamic instability as defined by any of the following: systolic blood pressure \<90 mmHg, use of vasopressors, use of IV inotropes to treat hypotension (systolic blood pressure \<90 mm Hg) or suspected/confirmed low cardiac output/shock, mechanical circulatory support, uncontrolled arrhythmias, active severe bleeding, or confirmed or suspected cardiogenic shock. Note: In the absence of the above conditions, use of inotropes to augment diuresis is permitted.
- Dyspnea due primarily to non-cardiac causes (e.g., severe chronic obstructive pulmonary disease or pneumonia).
- Poorly controlled diabetes
Lab values
- Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).
- Estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy (RRT).
- Severe baseline electrolyte abnormalities (e.g., serum potassium \<3.0 mEq/L or magnesium \<1.3 mEq/L). Note: These are based on baseline/screening labs. Subjects whose electrolyte levels are repleted cannot be reassessed for inclusion in the trial.
- Serum sodium \<135 mmol/L or history of severe hyponatremia
Other
- Inability to follow instructions or comply with follow-up procedures.
- Enrollment in another interventional trial during the index hospitalization
- Life expectancy less than 3 months
- Women who are pregnant or intend to become pregnant.
Who the study is looking for
- 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)
- ≥10 lb. (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.
- Patients ≥ 18 years of age able to provide informed consent and comply with study procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tbilisi Heart and Vascular Clinic Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.