NCT05015764

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2022

Completed
Last Updated

April 4, 2025

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

July 12, 2021

Last Update Submit

April 1, 2025

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Reprieve Cardiovascular System

EXPERIMENTAL
Device: Reprieve Cardiovascular System

Standard of Care

ACTIVE COMPARATOR
Other: Fluid Management

Interventions

Fluid ManagementOTHER

Removal of excess extracellular fluid using diuretics

Standard of Care
Reprieve Cardiovascular SystemDEVICE

System with Fluid Management Module

Reprieve Cardiovascular System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2021

First Posted

August 20, 2021

Study Start

April 12, 2021

Primary Completion

May 2, 2022

Study Completion

May 2, 2022

Last Updated

April 4, 2025

Record last verified: 2022-11

Locations

GE(1)