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

This study has been completed.
Sponsor:
Collaborator:
Abiomed Inc.
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00417378
First received: December 29, 2006
Last updated: November 27, 2007
Last verified: November 2007

December 29, 2006
November 27, 2007
August 2004
Not Provided
Cardiac index [ Time Frame: within 1 hour after device implantation ]
Hemodynamic improvement within 1 hour after device implantation (cardiac index)
Complete list of historical versions of study NCT00417378 on ClinicalTrials.gov Archive Site
  • Hemodynamic and metabolic parameters [ Time Frame: until to hospital discharge ]
  • Mortality [ Time Frame: within 30 and 180 days ]
  • device-related complications:hemolysis and major bleedings [ Time Frame: during hospitalization ]
  • Hemodynamic and metabolic parameters at longer follow-up
  • mortality at 30 days and 6 months
  • device-related complications:hemolysis and major bleedings
Not Provided
Not Provided
 
Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock (ISAR-SHOCK)
Left Ventricular Assist Device (Impella LP 2.5) vs. Intraaortic Balloon Counterpulsation (IABP) in Patients With Cardiogenic Shock and Acute Coronary Syndromes

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Shock, Cardiogenic
  • Myocardial Infarction
  • Device: Left Ventricular Assist Device Impella LP 2.5
    Left Ventricular Assist Device
  • Device: Intraaortic Balloon Pump
    Counterpulsation
  • Active Comparator: 1
    Intraaortic balloon counterpulsation (IABP)
    Intervention: Device: Intraaortic Balloon Pump
  • Experimental: 2
    Left Ventricular Assist Device (Impella LP2.5)
    Intervention: Device: Left Ventricular Assist Device Impella LP 2.5

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
March 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00417378
Impella M22
Yes
Not Provided
Deutsches Herzzentrum Muenchen
Abiomed Inc.
Study Chair: Melchior Seyfarth, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Josef Dirschinger, MD 1. Medizinische Klinik, Klinikum rechts der Isar
Deutsches Herzzentrum Muenchen
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP