Actively Recruiting
Reprieve System Pilot Study
Led by Reprieve Cardiovascular, Inc · Updated on 2026-02-05
50
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure.
CONDITIONS
Official Title
Reprieve System Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospitalized with a diagnosis of heart failure with at least 1 symptom (dyspnea, orthopnea, or edema/swelling) and 1 sign (peripheral edema, ascites, jugular venous distension, pulmonary vascular congestion on chest radiography)
- At least 10 lb. (4.5 kg) above dry weight by historical weight or health care provider estimate
- Age 18 years or older and able to provide informed consent and comply with study procedures
You will not qualify if you...
- Unable to place Foley catheter or IV catheter or other urologic issues that increase risk of injury or infection
- Hemodynamic instability such as low blood pressure (systolic <90 mmHg), use of vasopressors, IV inotropes for hypotension, mechanical circulatory support, uncontrolled arrhythmias, severe bleeding, or cardiogenic shock
- Dyspnea mainly caused by non-cardiac issues (e.g., severe COPD or pneumonia)
- Acute infection with systemic involvement (e.g., fever or high white blood cell count)
- Estimated glomerular filtration rate (eGFR) below 20 ml/min/1.73m2 or current renal replacement therapy
- Significant left ventricular outflow obstruction, severe heart valve disease, complex congenital heart disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, recent type 1 acute myocardial infarction (within 1 week), or other conditions making aggressive diuresis unsafe
- Unable to follow instructions or comply with follow-up
- Other diseases or conditions (including drug or alcohol abuse, psychiatric or cognitive disorders) that interfere with study compliance
- Severe baseline electrolyte abnormalities (serum potassium <3.0 mEq/L or magnesium <1.3 mEq/L) based on screening labs
- Serum sodium below 135 mmol/L or history of severe hyponatremia
- Poorly controlled diabetes
- Enrollment in another interventional trial during current hospitalization
- Life expectancy less than 3 months
- Women who are pregnant or intend to become pregnant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia, 0159
Actively Recruiting
Research Team
T
Tony Fields
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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