6 terminated, 4 completed, 1 withdrawn. 8 Not applicable, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 8 | Terminated 5, Completed 2, Withdrawn 1 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Ultrafiltration Versus IV Diuretics in Worsening Heart Failure Aquadex Smartflow® System, IV Loop Diuretics - Heart Failure (for Example, Fluid Overload), Heart Failure | Not applicable | Terminated | Nuwellis, Inc. | 167 | 2022-06-28 | 2026-06-25 |
| Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds) Aquadex™ System - Fluid Overload | Terminated | Nuwellis, Inc. | 97 | 2021-04-09 | 2024-02-20 | |
| A Feasibility Study on Ultrafiltration and Blood Volume Measurements Aquadex FlexFlow System and BVA-100 - Acute Decompensated Heart Failure, Fluid Overload | Not applicable | Terminated | Nuwellis, Inc. | 6 | 2019-12-19 | 2024-11-14 |
| C-Pulse® System European Multicenter Study Heart Failure | Completed | Nuwellis, Inc. | 15 | 2014-01-13 | 2023-08-08 | |
| C-Pulse® System: A Heart Assist Device Clinical Study C-Pulse® System Counterpulsation - Heart Failure | Not applicable | Terminated | Nuwellis, Inc. | 38 | 2012-09-12 | 2024-01-11 |
| Study of Heart Failure Hospitalizations After Aquapheresis Therapy Compared to Intravenous (IV) Diuretic Treatment Isolated veno-venous ultrafiltration (AQ), IV Loop Diuretics (LD) - Heart Failure, Cardiac Failure | Not applicable | Terminated | Nuwellis, Inc. | 224 | 2012-01-01 | 2023-08-29 |
| C-Pulse Implantable Counterpulsation Pump (ICP) - A Heart Assist Device C-Pulse™ (Implantable Counterpulsation Therapy) - Heart Failure | Not applicable | Terminated | Nuwellis, Inc. | 3 | 2010-06-21 | 2023-08-15 |
| C-Pulse IDE Feasibility Study- A Heart Assist System C-Pulse™ (Implantable Counterpulsation Therapy) - Heart Failure | Not applicable | Completed | Nuwellis, Inc. | 21 | 2008-09-10 | 2023-08-24 |
| Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure and Cardiorenal Syndrome (The CARRESS Study) Stepped pharmacologic care, Ultrafiltration - Heart Failure | Phase 3 | Completed | Duke University | 188 | 2008-03-01 | 2013-06-24 |
| Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial Ultrafiltration therapy - Congestive Heart Failure | Not applicable | Withdrawn | Hennepin Healthcare Research Institute | 2006-04-01 | 2012-10-04 | |
| Ultrafiltration Versus Intravenous (IV) Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: (UNLOAD) Aquadex system, IV diuretic - Congestive Heart Failure | Not applicable | Completed | Nuwellis, Inc. | 200 | 2004-04-01 | 2007-03-15 |
Heart Failure (9) · Edema (5) · Motor Activity (2) · Cardio-Renal Syndrome (1)
Sodium Potassium Chloride Symporter Inhibitors (2) · Ultrafiltration (2) · Diuretics (1) · Furosemide (1)
United States (9) · Canada (2) · Austria (1) · Germany (1)
Maria Rosa Costanzo, MD (2) · Bradley Bart, MD (1) · Kerry L. Lee, PhD (1) · Margarita T Camacho, MD (1) · Maria DeVita, MD, FASN (1) · Maria R Costanzo, MD (1) · Pat McCarthy, MD (1) · Renzo Cecere, MD (1) · Sean Pinney, MD (1) · Stuart Goldstein, MD (1) · William Abraham, MD (1) · William T Abraham, MD (1)
PMID 17291932, PMID 23131078, PMID 25301151, PMID 25543972, PMID 26041600, PMID 26887528, PMID 26927285, PMID 28130379, PMID 31163974, PMID 36787124
U01HL084904 (1)