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

April 1, 2025 updated by: Reprieve Cardiovascular, Inc
Reprieve Cardiovascular System for the Treatment of Subjects with Acute Decompensated Heart Failure Mechanistic Study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Georgia
      • Tbilisi, Georgia
        • Israeli-Georgian Medical Research Clinic Helsicore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

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 the study
  7. Enrollment in another interventional trial during the index hospitalization
  8. Life expectancy less than 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Other: Fluid Management
Removal of excess extracellular fluid using diuretics
Experimental: Reprieve Cardiovascular System
Device: Reprieve Cardiovascular System
System with Fluid Management Module

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
End of treatment, an average of 24 hours
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
Through study completion, an average of 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reprieve Cardiovascular, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Actual)

May 2, 2022

Study Completion (Actual)

May 2, 2022

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCV-0005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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