Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock (ISAR-SHOCK)
NCT00417378 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2007-11-28
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).
Conditions
- Shock, Cardiogenic
- Myocardial Infarction
Interventions
- DEVICE
-
Left Ventricular Assist Device Impella LP 2.5
Left Ventricular Assist Device
- DEVICE
-
Intraaortic Balloon Pump
Counterpulsation
Sponsors & Collaborators
-
Abiomed Inc.
collaborator INDUSTRY -
Deutsches Herzzentrum Muenchen
lead OTHER
Principal Investigators
-
Melchior Seyfarth, MD · Deutsches Herzzentrum Muenchen
-
Josef Dirschinger, MD · 1. Medizinische Klinik, Klinikum rechts der Isar
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-08-31
- Completion
- 2006-03-31
Countries
- Germany
Study Locations
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