Reprieve Cardiovascular System for the Treatment of Subjects With Acute Decompensated Heart Failure Mechanistic Study

Last updated: April 1, 2025
Sponsor: Reprieve Cardiovascular, Inc
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Heart Failure

Treatment

Fluid Management

Reprieve Cardiovascular System

Clinical Study ID

NCT05015764
RCV-0005
  • Ages > 18
  • All Genders

Study Summary

Reprieve Cardiovascular System for the Treatment of Subjects with Acute Decompensated Heart Failure Mechanistic Study

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Hospitalized with a diagnosis of heart failure

  2. 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

  2. Hemodynamic instability

  3. Dyspnea due primarily to non-cardiac causes

  4. Acute infection with evidence of systemic involvement

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

  6. Other concomitant disease or condition that investigator deems unsuitable for thestudy

  7. Enrollment in another interventional trial during the index hospitalization

  8. Life expectancy less than 3 months

Study Design

Total Participants: 31
Treatment Group(s): 2
Primary Treatment: Fluid Management
Phase:
Study Start date:
April 12, 2021
Estimated Completion Date:
May 02, 2022

Study Description

The key objective of the trial was to provide an optimized decongestion treatment for subjects with acute decompensated heart failure and identify the critical parameters that could be incorporated into the design of the next generation of the Reprieve Cardiovascular System.

Connect with a study center

  • Israeli-Georgian Medical Research Clinic Helsicore

    Tbilisi,
    Georgia

    Site Not Available

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