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Ultrafiltration Device

Single-arm for Heart Failure

N/A

Waitlist Available

Led By Maria Rosa Costanzo, MD

Research Sponsored by Nuwellis, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, average of 1 year

Awards & highlights

Study Summary

This trial will test how well the Aquadex FlexFlow system works to remove fluid in people with acute decompensated heart failure, and whether monitoring blood volume changes during therapy could help guide treatment.

Eligible Conditions

Acute Heart Failure
Fluid Overload

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

1. Evaluate changes in blood volume as measured by BVA from before initiation until completion of extracorporeal fluid removal by ultrafiltration

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

3. Evaluate the temporal relationship between changes in blood volume, as measured by BVA , and changes in clinical signs and symptoms of fluid overload

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single-armExperimental Treatment1 Intervention

No comparator, placebo, or randomization

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Who is running the clinical trial?

Nuwellis, Inc.Lead Sponsor

10 Previous Clinical Trials

1,158 Total Patients Enrolled

9 Trials studying Heart Failure

1,061 Patients Enrolled for Heart Failure

Daxor CorporationIndustry Sponsor

12 Previous Clinical Trials

323 Total Patients Enrolled

7 Trials studying Heart Failure

212 Patients Enrolled for Heart Failure

Maria Rosa Costanzo, MDPrincipal InvestigatorEdward-Elmhurst Health System

2 Previous Clinical Trials

710 Total Patients Enrolled

2 Trials studying Heart Failure

710 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count in this clinical investigation?

"Affirmative. The clinicaltrials.gov website attests to this trial's current recruitment status, which began on December 19th 2019 and has been amended as of August 19th 2022. 15 subjects are being enrolled across a single site."

Answered by AI

Are new participants being sought to join this research?

"Per information available on clinicaltrials.gov, this trial is presently looking for participants. It was initially advertised on December 19th 2019 and most recently updated on August 19th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Feasibility Study on Ultrafiltration and Blood Volume Measurements

2019. "A Feasibility Study on Ultrafiltration and Blood Volume Measurements". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04241718.