Reprieve Cardiovascular System for the Treatment of Subje... | NCT05015764

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

NCT05015764

Sponsor

Reprieve Cardiovascular, Inc

Status

Completed

Last Update Posted

Apr 4, 2025Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Heart Failure

Interventions

Fluid Management
Reprieve Cardiovascular System

Countries

Georgia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2021Actual

Primary Completion Date

May 2, 2022Actual

Completion Date

May 2, 2022Actual

First Submitted Date

Jul 12, 2021

First Submission Date that Met QC Criteria

Aug 16, 2021

First Posted Date

Aug 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2025

Last Update Posted Date

Apr 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reprieve Cardiovascular System	Experimental		Device: Reprieve Cardiovascular System
Standard of Care	Active Comparator		Other: Fluid Management

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluid Management	Other	Removal of excess extracellular fluid using diuretics	Standard of Care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fractional Excretion of Sodium measured during therapy	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	Rate of device and procedure related AEs and SAEs	Through study completion, an average of 90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Israeli-Georgian Medical Research Clinic Helsicore		Tbilisi			Georgia

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided