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Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock (ISAR-SHOCK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00417378
Recruitment Status : Completed
First Posted : January 1, 2007
Last Update Posted : November 28, 2007
Abiomed Inc.
Information provided by:
Deutsches Herzzentrum Muenchen

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).

Condition or disease Intervention/treatment Phase
Shock, Cardiogenic Myocardial Infarction Device: Left Ventricular Assist Device Impella LP 2.5 Device: Intraaortic Balloon Pump Phase 4

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2004
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: 1
Intraaortic balloon counterpulsation (IABP)
Device: Intraaortic Balloon Pump

Experimental: 2
Left Ventricular Assist Device (Impella LP2.5)
Device: Left Ventricular Assist Device Impella LP 2.5
Left Ventricular Assist Device

Primary Outcome Measures :
  1. Cardiac index [ Time Frame: within 1 hour after device implantation ]

Secondary Outcome Measures :
  1. Hemodynamic and metabolic parameters [ Time Frame: until to hospital discharge ]
  2. Mortality [ Time Frame: within 30 and 180 days ]
  3. device-related complications:hemolysis and major bleedings [ Time Frame: during hospitalization ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00417378

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Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
1. Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Abiomed Inc.
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Study Chair: Melchior Seyfarth, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Josef Dirschinger, MD 1. Medizinische Klinik, Klinikum rechts der Isar

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00417378    
Other Study ID Numbers: Impella M22
First Posted: January 1, 2007    Key Record Dates
Last Update Posted: November 28, 2007
Last Verified: November 2007
Keywords provided by Deutsches Herzzentrum Muenchen:
Additional relevant MeSH terms:
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Myocardial Infarction
Shock, Cardiogenic
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases