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Completed

NCT Number: NCT05015764

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

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

Completed

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized with a diagnosis of heart failure
  • Patients ≥ 18 years of age able to provide informed consent and comply with study procedures.

Exclusion criteria

  • Inability to place Foley catheter or IV catheter
  • Hemodynamic instability
  • Dyspnea due primarily to non-cardiac causes
  • Acute infection with evidence of systemic involvement
  • Inability to follow instructions or comply with follow-up procedures.
  • Other concomitant disease or condition that investigator deems unsuitable for the study
  • Enrollment in another interventional trial during the index hospitalization
  • Life expectancy less than 3 months

Treatment and study plan

Fluid Management

Other

Removal of excess extracellular fluid using diuretics

Reprieve Cardiovascular System

Device

System with Fluid Management Module

Primary outcomes

  1. Fractional Excretion of Sodium measured during therapy

    Time frame: End of treatment, an average of 24 hours

    Average fractional excretion of sodium across all patients measured during therapy

  2. Device and Procedure related AEs and SAEs

    Time frame: Through study completion, an average of 90 days

    Rate of device and procedure related AEs and SAEs

Sponsors and collaborators

Lead sponsor

Reprieve Cardiovascular, Inc

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2021
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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