Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417378
Status:
COMPLETED
Last Update Posted:
2007-11-28
First Post:
2006-12-29
Brief Title:
Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock ISAR-SHOCK
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Deutsches Herzzentrum Muenchen
Study Overview
Official Title:
Left Ventricular Assist Device Impella LP 25 vs Intraaortic Balloon Counterpulsation IABP in Patients With Cardiogenic Shock and Acute Coronary Syndromes
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 ACCAHA 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 LP25 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 25 Lmin Randomized data comparing the LVAD with IABP are missing Therefore this trial will primarily compare the hemodynamic improvement of the LVAD Impella LP25 with the hemodynamic improvement of an intraaortic balloon counterpulsation IABP while secondarily feasibility safety and mortality will be compared
Previous studies have demonstrated a significant improvement of hemodynamic parameters by the use of a catheter-based miniaturized rotary blood pump Impella LP25 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 25 Lmin Randomized data comparing the LVAD with IABP are missing Therefore this trial will primarily compare the hemodynamic improvement of the LVAD Impella LP25 with the hemodynamic improvement of an intraaortic balloon counterpulsation IABP while secondarily feasibility safety and mortality will be compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None