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

Reprieve Cardiovascular, Inc31 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

Fluid ManagementOTHER

Removal of excess extracellular fluid using diuretics

Reprieve Cardiovascular SystemDEVICE

System with Fluid Management Module

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

Outcomes

Primary Outcomes

Fractional Excretion of Sodium measured during therapy

Average fractional excretion of sodium across all patients measured during therapy

Time frame: End of treatment, an average of 24 hours

Device and Procedure related AEs and SAEs

Rate of device and procedure related AEs and SAEs

Time frame: Through study completion, an average of 90 days

Data from ClinicalTrials.gov

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