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
About this trial
This is an interventional treatment trial for Heart Failure
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
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
NCT ID
NCT05015764
First Posted
July 12, 2021
Last Updated
November 2, 2022
Sponsor
Reprieve Cardiovascular, Inc
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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