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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
  Purpose

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 Intervention Phase
Shock, Cardiogenic
Myocardial Infarction
Device: Left Ventricular Assist Device Impella LP 2.5
Device: Intraaortic Balloon Pump
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: August 2004
Study Completion Date: March 2006
Arms Assigned Interventions
Active Comparator: 1
Intraaortic balloon counterpulsation (IABP)
Device: Intraaortic Balloon Pump
Counterpulsation
Experimental: 2
Left Ventricular Assist Device (Impella LP2.5)
Device: Left Ventricular Assist Device Impella LP 2.5
Left Ventricular Assist Device

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417378

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

Publications:
ClinicalTrials.gov Identifier: NCT00417378     History of Changes
Other Study ID Numbers: Impella M22
Study First Received: December 29, 2006
Last Updated: November 27, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:
ACS

Additional relevant MeSH terms:
Shock
Shock, Cardiogenic
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014