Reprieve System Pilot Study

NCT ID: NCT06272734

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-23
• Study Completion Date: 2026-12-31

Brief Summary

The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure.

Conditions

Acute Decompensated Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reprieve System

Subjects will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.

Group Type: EXPERIMENTAL

Reprieve System

Intervention Type: DEVICE

The study is broken into stages:

1. In Stage one, Subjects enrolled in the study received Reprieve System (RS) therapy, a hospital bedside fluid management system designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure. (complete, N=10)

2. In future Stages, Subjects enrolled in the study will receive RS therapy and will be given varying levels of water consumption to challenge the algorithm. Future Stages will also assess new RS hardware and software features.

Interventions

Reprieve System

The study is broken into stages:

1. In Stage one, Subjects enrolled in the study received Reprieve System (RS) therapy, a hospital bedside fluid management system designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure. (complete, N=10)

2. In future Stages, Subjects enrolled in the study will receive RS therapy and will be given varying levels of water consumption to challenge the algorithm. Future Stages will also assess new RS hardware and software features.

Intervention Type: DEVICE

Eligibility Criteria

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 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.

3. Dyspnea due primarily to non-cardiac causes (e.g., severe chronic obstructive pulmonary disease or pneumonia).

4. Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).

5. Estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy (RRT).

6. 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.

7. Inability to follow instructions or comply with follow-up procedures.

8. 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.

9. 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.

10. Serum sodium <135 mmol/L or history of severe hyponatremia

11. Poorly controlled diabetes

12. Enrollment in another interventional trial during the index hospitalization

13. Life expectancy less than 3 months

14. Women who are pregnant or intend to become pregnant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reprieve Cardiovascular, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamaz Shaburishvili, MD

Role: PRINCIPAL_INVESTIGATOR

Tbilisi Heart and Vascular Clinic

Locations

Tbilisi Heart and Vascular Clinic

Tbilisi, , Georgia

Site Status: RECRUITING

Countries

Georgia

Central Contacts

Tony Fields

Role: CONTACT

tfields@reprievecardio.com

+1-650-224-3884

Facility Contacts

Tamaz Shaburishvili, MD

Role: primary

tamaz_shaburishvili@yahoo.com

+995 322 479300

Other Identifiers

RCV-0007

Identifier Type: -

Identifier Source: org_study_id