Reprieve System Pilot Study

NCT06272734 | Recruiting FDA Device

• 1 other identifier: RCV-0007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Functional Device Success

  Defined as the device's ability to perform its intended function as specified in the study protocol without any device-related adverse events or malfunctions as determined by the treating physician.

  Over the 72-hours maximum duration of therapy.

Study Arms (1)

Reprieve System

EXPERIMENTAL

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

Device: Reprieve System

Interventions

Reprieve System 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.

Reprieve System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).
• 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.
• Inability to follow instructions or comply with follow-up procedures.
• 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.
• Serum sodium \<135 mmol/L or history of severe hyponatremia
• Poorly controlled diabetes
• Enrollment in another interventional trial during the index hospitalization
• Life expectancy less than 3 months
• Women who are pregnant or intend to become pregnant.

Sponsors & Collaborators

• Reprieve Cardiovascular, Inc: lead

Study Sites (1)

Tbilisi Heart and Vascular Clinic

Tbilisi, 0159, Georgia

RECRUITING

Study Officials

• Tamaz Shaburishvili, MD

  Tbilisi Heart and Vascular Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony Fields

CONTACT

+1-650-224-3884; tfields@reprievecardio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: January 23, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1)