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A Feasibility Study on Ultrafiltration and Blood Volume Measurements

NCT04241718 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-11-14

No results posted yet for this study

Summary

The objective of this feasibility study is to characterize the performance of the Aquadex FlexFlow® System with the hematocrit (HCT) feature in conjunction with Daxor's blood volume analyzer (BVA-100). The study will monitor blood volume changes during ultrafiltration (UF) therapy as a potential means to guide the removal of fluid in subjects hospitalized with acute decompensated heart failure (ADHF).

Conditions

  • Acute Decompensated Heart Failure
  • Fluid Overload

Interventions

DEVICE

Aquadex FlexFlow System and BVA-100

Aquapheresis therapy with Aquadex FlexFlow System and Blood Volume Measurement with BVA-100

Sponsors & Collaborators

  • Daxor Corporation

    collaborator INDUSTRY

  • Nuwellis, Inc.

    lead INDUSTRY

Principal Investigators

  • Maria Rosa Costanzo, MD · Edward Hospital Center for Advanced Heart Failure

  • Maria Rosa Costanzo, MD · Edward-Elmhurst Health System

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2022-12-27
Completion
2022-12-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04241718 on ClinicalTrials.gov