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| Sponsor: | Deutsches Herzzentrum Muenchen |
|---|---|
| Collaborator: |
Abiomed Inc. |
| Information provided by: | Deutsches Herzzentrum Muenchen |
| ClinicalTrials.gov Identifier: | NCT00417378 |
Purpose
The purpose of this study is to evaluate the efficacy and safety of a left ventricular assist device in comparison to a standard treatment with an intraaortic balloon pump (IABP) in patients with cardiogenic shock due to left ventricular failure following an acute coronary syndrome (myocardial infarction).
| Condition | Intervention | Phase |
|---|---|---|
|
Shock, Cardiogenic Myocardial Infarction |
Device: Left Ventricular Assist Device Impella LP 2.5 Device: Intraaortic Balloon Pump |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Left Ventricular Assist Device (Impella LP 2.5) vs. Intraaortic Balloon Counterpulsation (IABP) in Patients With Cardiogenic Shock and Acute Coronary Syndromes |
| Enrollment: | 26 |
| Study Start Date: | August 2004 |
| Study Completion Date: | March 2006 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Intraaortic balloon counterpulsation (IABP)
|
Device: Intraaortic Balloon Pump
Counterpulsation
|
|
Experimental: 2
Left Ventricular Assist Device (Impella LP2.5)
|
Device: Left Ventricular Assist Device Impella LP 2.5
Left Ventricular Assist Device
|
Cardiogenic shock due to a left ventricular failure after myocardial infarction (MI) is associated with a mortality rate of 50-70 % despite all efforts such as immediate PCI of the occluded vessel, positive inotropic drugs, and the use of intraaortic balloon counterpulsation (IABP). While urgent heart transplantation or the surgical implantation of high-volume left ventricular assist devices are possible treatment options, a widespread use of these techniques for this common complication of myocardial infarction is limited. Because of the easy, percutaneous use of an intraaortic balloon pump, IABP is the method of choice for mechanical assistance in these patients. Despite a lack of randomized data, the ACC/AHA guidelines recommend the use of an intraaortic balloon counterpulsation (Level of evidence IB) in patients with a cardiogenic shock after myocardial infarction. However, improvement of the hemodynamic state by the use of an IABP is limited and the lack of an active cardiac support remains the major limitation of this treatment. Percutaneous left ventricular assist devices may both overcome the limitation of a surgical approach and offer the potential benefit of an active cardiac support during recovery of the failing left ventricle after PCI.
Previous studies have demonstrated a significant improvement of hemodynamic parameters by the use of a catheter-based miniaturized rotary blood pump (Impella LP2.5, Abiomed-Impella CardioSystems GmbH, Aachen, Germany), that is placed retrogradely through the aortic valve. The microaxial pump aspirates blood from the left ventricle and expels it to the ascending aorta with a maximal flow of 2.5 L/min. Randomized data comparing the LVAD with IABP are missing. Therefore, this trial will primarily compare the hemodynamic improvement of the LVAD (Impella LP2.5) with the hemodynamic improvement of an intraaortic balloon counterpulsation (IABP), while secondarily feasibility, safety and mortality will be compared.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Acute coronary syndrome (ACS/AMI) < 48h and cardiogenic shock defined as:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Deutsches Herzzentrum Muenchen | |
| Munich, Germany, 80636 | |
| 1. Medizinische Klinik, Klinikum rechts der Isar | |
| Munich, Germany, 81675 | |
| Study Chair: | Melchior Seyfarth, MD | Deutsches Herzzentrum Muenchen |
| Principal Investigator: | Josef Dirschinger, MD | 1. Medizinische Klinik, Klinikum rechts der Isar |
More Information
| ClinicalTrials.gov Identifier: | NCT00417378 History of Changes |
| Other Study ID Numbers: | Impella M22 |
| Study First Received: | December 29, 2006 |
| Last Updated: | November 27, 2007 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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ACS |
|
Infarction Myocardial Infarction Shock Shock, Cardiogenic Acute Coronary Syndrome Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Angina Pectoris Chest Pain Pain Signs and Symptoms |