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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
Fluid Management
Reprieve Cardiovascular System
Sponsored by
Reprieve Cardiovascular, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Israeli-Georgian Medical Research Clinic Helsicore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reprieve Cardiovascular System

Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

Fractional Excretion of Sodium measured during therapy
Average fractional excretion of sodium across all patients measured during therapy
Device and Procedure related AEs and SAEs
Rate of device and procedure related AEs and SAEs

Secondary Outcome Measures

Full Information

First Posted
July 12, 2021
Last Updated
November 2, 2022
Sponsor
Reprieve Cardiovascular, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05015764
Brief Title
Reprieve Cardiovascular System for the Treatment of Subjects With Acute Decompensated Heart Failure Mechanistic Study
Official Title
Reprieve Cardiovascular System for the Treatment of Subjects With Acute Decompensated Heart Failure Mechanistic Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
May 2, 2022 (Actual)
Study Completion Date
May 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reprieve Cardiovascular, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reprieve Cardiovascular System
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Fluid Management
Intervention Description
Removal of excess extracellular fluid using diuretics
Intervention Type
Device
Intervention Name(s)
Reprieve Cardiovascular System
Intervention Description
System with Fluid Management Module
Primary Outcome Measure Information:
Title
Fractional Excretion of Sodium measured during therapy
Description
Average fractional excretion of sodium across all patients measured during therapy
Time Frame
End of treatment, an average of 24 hours
Title
Device and Procedure related AEs and SAEs
Description
Rate of device and procedure related AEs and SAEs
Time Frame
Through study completion, an average of 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Israeli-Georgian Medical Research Clinic Helsicore
City
Tbilisi
Country
Georgia

12. IPD Sharing Statement

Learn more about this trial

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

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