Reprieve System Pilot Study

Last updated: March 7, 2025
Sponsor: Reprieve Cardiovascular, Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Heart Failure

Congestive Heart Failure

Treatment

Reprieve System

Clinical Study ID

NCT06272734
RCV-0007
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Hospitalized with a diagnosis of heart failure as defined by the presence of atleast 1 symptom (dyspnea, orthopnea, or edema/swelling) AND 1 sign (peripheraledema, ascites, jugular venous distension, pulmonary vascular congestion on chestradiography)

  2. ≥10 lb. (4.5 kg) above dry weight either by historical weights or as estimated byhealth care provider.

  3. Patients ≥ 18 years of age able to provide informed consent and comply with studyprocedures.

Exclusion

Exclusion Criteria:

  1. Inability to place Foley catheter or IV catheter or other urologic issues that wouldpredispose the patient to a high rate of urogenital trauma or infection withcatheter 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 (systolicblood pressure <90 mm Hg) or suspected/confirmed low cardiac output/shock,mechanical circulatory support, uncontrolled arrhythmias, active severe bleeding, orconfirmed or suspected cardiogenic shock. Note: In the absence of the aboveconditions, use of inotropes to augment diuresis is permitted.

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

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

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

  6. Significant left ventricular outflow obstruction, uncorrected complex congenitalheart disease, known severe stenotic valvular disease, infiltrative or constrictivecardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiringtreatment (within previous week), or any other pathology that, in the opinion of theinvestigator, 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 thestudy, including drug or alcohol abuse or psychiatric, behavioral, or cognitivedisorders, sufficient to interfere with the patient's ability to understand andcomply with the protocol instructions or follow-up procedures.

  9. Severe baseline electrolyte abnormalities (e.g., serum potassium <3.0 mEq/L ormagnesium <1.3 mEq/L). Note: These are based on baseline/screening labs. Subjectswhose electrolyte levels are repleted cannot be reassessed for inclusion in thetrial.

  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.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Reprieve System
Phase:
Study Start date:
January 23, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Tbilisi Heart and Vascular Clinic

    Tbilisi, 0159
    Georgia

    Active - Recruiting

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