Status:
COMPLETED
Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock (ISAR-SHOCK)
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Collaborating Sponsors:
Abiomed Inc.
Conditions:
Shock, Cardiogenic
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 card...
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, po...
Eligibility Criteria
Inclusion
- Acute coronary syndrome (ACS/AMI) \< 48h and cardiogenic shock defined as:
- Clinical criteria: Hypotension (syst.BP \< 90 mmHg and HR \> 90/min or an AV- Block II-III) or the need for positive inotropic drugs to maintain BB \> 90mm Hg)and end-organ hypoperfusion
- Hemodynamic criteria: CI \< 2.2 L/min/qm and a PCWP \> 15 mmHg or an EF of LV \< 30% and LVEDP \> 20 mmHg.
- Written informed consent of the patient or his/hers relatives
Exclusion
- Age \< 18 years
- Prolonged Resuscitation (\> 30min)
- Hypertrophic Obstructive Cardiomyopathy
- Thrombus in left ventricle
- Treatment with IABP
- Severe valvular disease or mechanical heart valve
- Cardiogenic Shock due to mechanical complications of myocardial infarction such as VSD, acute mitral regurgitation \>II°, rupture of the ventricle
- Failure of the right ventricle defined as the need for a RV Assist Device
- Septic condition
- Cerebral Disease
- Bleeding with a need for surgical intervention
- Pulmonary embolism
- Allergy to Heparin or any known coagulopathy
- Aortic regurgitation \>II°
- Pregnancy
- Inclusion in another study or trial
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00417378
Start Date
August 1 2004
End Date
March 1 2006
Last Update
November 28 2007
Active Locations (2)
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1
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
2
1. Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675