The objective of this pilot study is to compare decongestive therapy administered by the Reprieve System to optimize diuretic therapy in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve System can more efficiently decongest ADHF patients in comparison to Control Therapy. This trial is enrolling patients in the United States and Europe.

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 < 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy (RRT). Note: In the absence of the above conditions, the 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 study instructions or
follow-up procedures.

Severe electrolyte abnormalities (e.g., serum potassium mEq/L, magnesium electrolyte
levels are repleted cannot be reassessed for inclusion in the trial. Note: These are based on
baseline/screening labs. Subjects whose electrolyte levels are repleted cannot be
reassessed for inclusion in the trial.

Enrollment in another interventional trial during the index hospitalization.

Inability to return for follow-up study visits.

Women who are pregnant or intend to become pregnant.

The sponsor does not expect that these exclusion criteria will disproportionately exclude the
Medicare population who are Medicare-eligible due to either age or end-stage renal disease
(ESRD).

Clinical Trial

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).

≥10 lb. (4.5 kg) above dry weight either by historical weights or as estimated by health
care provider.

Prior use of outpatient oral loop diuretics within 30 days prior to admission.

Patients ≥ 18 years of age are able to provide informed consent and comply with study
procedures.

The sponsor expects that the Medicare population who are Medicare eligible
due to either age or End Stage Renal Disease (ESRD) will be included under these criteria.

FASTR Trial description on ClinicalTrials.gov

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The objective of the FASTR Pilot Study is to compare decongestive therapy administered by the Reprieve System to optimized diuretic therapy in the treatment of patients diagnosed with acute decompensated heart failure (ADHF).

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The FASTR trial is currently enrolling patients in the United States and Europe.

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FASTR Trial

Fluid management of Acute decompensated heart failure Subjects Treated with Reprieve System

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