Reprieve System Pilot Study
ConditionAcute Decompensated Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorReprieve Cardiovascular, Inc
About this trial
The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Reprieve System
DeviceThe 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Reprieve SystemExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Over the 72-hours maximum duration of therapy.Sponsors and contacts
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Source ClinicalTrials.gov