Not provided
Not provided
Not provided
Not provided
Not provided
Slow enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Daxor Corporation | INDUSTRY |
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | Other | No comparator, placebo, or randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquadex FlexFlow System and BVA-100 | Device | Aquapheresis therapy with Aquadex FlexFlow System and Blood Volume Measurement with BVA-100 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. Evaluate changes in blood volume as measured by BVA from before initiation until completion of extracorporeal fluid removal by ultrafiltration | BVA will be used to evaluate changes in blood volume from baseline (i.e., before initiation) until completion of extracorporeal fluid removal by ultrafiltration. | Through study procedure completion, average of 2 weeks |
| 2. Evaluate if changes in blood volume, as measured by BVA, correlate with changes in HCT as measured by the device embedded in the Aquadex FlexFlow System ultrafiltration device | A correlation between BVA measured change in blood volume to changes in hematocrit (HCT) as measured by the online HCT sensor embedded in the Aquadex Flexflow system will be determined. | Through study procedure completion, average of 2 weeks |
| 3. Evaluate the temporal relationship between changes in blood volume, as measured by BVA , and changes in clinical signs and symptoms of fluid overload | Temporal relationship between blood volume change (as measured by the BVA) and changes in clinical signs and symptoms of fluid overload will be evaluated. | Through study procedure completion, average of 2 weeks |
| 4. Evaluate the temporal relationship between changes in HCT, as measured by Aquadex HCT, and changes in clinical signs and symptoms of fluid overload | Temporal relationship between HCT change (as measured by Aquadex HCT sensor) and changes in clinical signs and symptoms of fluid overload will be evaluated. | Through study procedure completion, average of 2 weeks |
| 5. Total net fluid loss prior to hospital discharge | The total net fluid removed during the ultrafiltration therapy will be evaluated. | Daily during study procedure, average of 2 weeks |
Not provided
Not provided
Inclusion Criteria:
Age 18 years or older
Subject or legally authorized representative is able to provide appropriate consent to participate
Hospitalized for ADHF with fluid overload as indicated by at least two of the following:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maria Rosa Costanzo, MD | Edward Hospital Center for Advanced Heart Failure | Principal Investigator |
| Maria Rosa Costanzo, MD | Edward-Elmhurst Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Cardiovascular Institute | Naperville | Illinois | 60540 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6. Change in urinary sodium concentration from baseline to ultrafiltration completion | Urinary sodium concentration profile from baseline to ultrafiltration completion will be evaluated. | Through study procedure completion, average of 2 weeks |
| 7. Change in biomarkers from baseline until discharge: |
| through study completion, average of 2 weeks |
| 8. Adverse events of special interest |
| through study completion, average of 1 year |