NCT04241718

A Feasibility Study on Ultrafiltration and Blood Volume Measurements

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Nuwellis, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study will measure blood volumes at various time intervals using the BVA-100 for comparison to corresponding readings of hematocrit (HCT) levels from the Aquadex FlexFlow HCT sensor. Establishing a correlation between BVA measurements (off-line measurements) and HCT sensor measurements (on-line measurements) may enable the use of the BVA-100 to guide ultrafiltration therapy by the Aquadex system for fluid removal. BVA-100 measurements would be used at baseline to accurately determine patient suitability for fluid removal and while HCT measurements would be used to monitor blood volume changes during ultrafiltration therapy, potentially guiding the removal of fluid in subjects hospitalized with ADHF.

Conditions

• Acute Decompensated Heart Failure
• Fluid Overload

Interventions

Type	Name	Description
DEVICE	Aquadex FlexFlow System and BVA-100	Aquapheresis therapy with Aquadex FlexFlow System and Blood Volume Measurement with BVA-100

Timeline

• Start date: 2019-12-19
• Primary completion: 2022-12-27
• Completion: 2022-12-27
• First posted: 2020-01-27
• Last updated: 2024-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study