16 completed, 8 active not recruiting, 7 unknown, 6 recruiting. 19 Not applicable, 3 Phase 2, 3 Phase 3, 1 Phase 1, 1 Phase 4.
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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 |
|---|---|---|---|---|---|---|
| INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery Impella 5.5 SmartAssist - Heart Failure, Cardiogenic Shock | Not applicable | Recruiting | Abiomed Inc. | 250 | 2026-10-02 | 2026-10-13 |
| Impella Pump Return Study to Analyze Deposits and Biomaterial in Used Pumps Heart Failure | Recruiting | Abiomed Inc. | 200 | 2025-09-21 | 2025-10-03 | |
| Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock Impella - AMI Cardiogenic Shock | Recruiting | Abiomed Inc. | 350 | 2025-07-10 | 2026-10-27 | |
| Platelet Function and Impella Support Analysis of platelet function - Cardiogenic Shock, Cardiac Arrest | Completed | Università Vita-Salute San Raffaele | 30 | 2025-02-24 | 2026-05-05 | |
| Impella Reverse Remodeling in End-Stage Heart Failure Heart Failure, Cardiomyopathy | Recruiting | Columbia University | 50 | 2024-12-04 | 2026-08-19 | |
| Abiomed Impella RT-DAQ - Observational Study Data Acquisition - Cardiogenic Shock | Recruiting | Abiomed Inc. | 125 | 2024-10-04 | 2026-06-17 | |
| Impella RP Flex with Smart Assist Right-sided ventricular assist device - Right Ventricular (RV) Dysfunction | Unknown | Abiomed Inc. | 200 | 2024-05-29 | 2024-10-15 | |
| Awake Axillary Impella 5.5 Placement - A Feasibility Trial Interscalene Block, PECS II Block, Superficial Cervical Plexus Block - Cardiogenic Shock | Not applicable | Withdrawn | University of Pennsylvania | 2024-04-01 | 2024-07-19 | |
| The RECOVER IV Trial Impella CP®, Standard of Care - ST-segment Elevation Myocardial Infarction (STEMI), Cardiogenic Shock | Not applicable | Terminated | Abiomed Inc. | 4 | 2023-10-28 | 2025-01-29 |
| V-A ECMO AUTO Mode Registry V-A ECMO AUTO Mode algorithm - Heart Failure | Completed | Abiomed Inc. | 46 | 2023-10-11 | 2025-07-03 | |
| Unloading in Heart Failure Cardiogenic Shock Impella 5.5, Inotropes - Cardiogenic Shock | Not applicable | Not yet recruiting | Amsterdam UMC, location VUmc | 456 | 2023-10-01 | 2023-08-01 |
| IMpella-Protected cArdiaC Surgery Trial (IMPACT) Impella 5.5 with SmartAssist - Left Ventricular Dysfunction | Not applicable | Completed | Abiomed Inc. | 100 | 2023-09-21 | 2026-08-28 |
| IMPACT EU Post-Market Clinical Follow-Up Study Device: Impella 5.5 with SmartAssist - Left Ventricular Dysfunction | Not applicable | Active not recruiting | Abiomed Inc. | 123 | 2023-04-27 | 2025-09-30 |
| Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol Impella ECP - High-Risk Percutaneous Coronary Intervention | Not applicable | Enrolling by invitation | Abiomed Inc. | 856 | 2022-12-20 | 2026-03-05 |
| Impella Real-World Surveillance of Patients Using Sodium Bicarbonate Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution, Impella RP with Sodium Bicarbonate used as purge solution - Cardiogenic Shock, High Risk PCI | Completed | Abiomed Inc. | 312 | 2022-12-15 | 2024-09-04 | |
| The PROTECT-EU Study PCI procedure - High-risk PCI | Unknown | Fondazione GISE Onlus | 859 | 2022-10-18 | 2024-03-04 | |
| Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock Cardiogenic Shock, Acute Myocardial Infarction | Active not recruiting | Henry Ford Health System | 124 | 2022-07-22 | 2026-04-17 | |
| Impella Supported OPCABG Impella 5.5 with SmartAssist Supported OPCABG - Ischemic Cardiomyopathy | Active not recruiting | Lucian Archambault Durham III | 30 | 2022-05-11 | 2025-01-27 | |
| Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study Impella BTR - Heart Failure, Acute Decompensated Heart Failure | Not applicable | Active not recruiting | Abiomed Inc. | 10 | 2022-04-20 | 2026-01-08 |
| Hemodynamic Effects Of Impella On Renal Circulation And Risk Of CA-AKI Among Patients Undergoing Protected PCI Evaluate the blood flow and pressure into kidneys - Contrast-induced Acute Kidney Injury (CI-AKI) | Withdrawn | Virginia Commonwealth University | 2022-01-01 | 2022-02-04 |
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Shock, Cardiogenic (14) · Heart Failure (12) · ST Elevation Myocardial Infarction (6) · Cardiovascular Diseases (4) · Coronary Artery Disease (4) · Heart Diseases (4) · Myocardial Infarction (4) · Non-ST Elevated Myocardial Infarction (4) · Ventricular Dysfunction, Left (3) · Myocardial Ischemia (2) · Angina, Stable (1) · Angina, Unstable (1) · Anterior Wall Myocardial Infarction (1) · Arterial Occlusive Diseases (1) · Arteriosclerosis (1)
Intra-Aortic Balloon Pumping (2) · Standard of Care (2) · Cervical Plexus Block (1) · Vasoconstrictor Agents (1)
United States (33) · Germany (9) · Italy (5) · Canada (4) · Netherlands (4) · Switzerland (4) · United Kingdom (2) · Czechia (1) · Denmark (1)
William O'Neill, MD (4) · Navin Kapur, MD (3) · Alexander Kersten, MD (2) · Amir Kaki, MD (2) · David D'Alessandro, MD (2) · Edward Soltesz, MD (2) · Mark Anderson, MD (2) · Seth Bilazarian, MD (2) · William O'Neill, M.D. (2) · William W O'Neill, MD (2) · A. Reshad Garan, MD (1) · Adam DeVore, MD, MHS (1) · Adil Yunis, MS (1) · Ahmad Zeeshan, MD (1) · Ajay Kirtane, MD (1)
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