Use of Mechanical Assist Sample Clauses

Use of Mechanical Assist. Intra-Aortic Balloon Pump or Ventricular Assist Devices (through Day 5) 49 9.3 Efficacy Criteria 49 9.3.1 Composite Co-primary Efficacy Endpoints 49 9.3.2 Secondary Efficacy Endpoints 49 9.4 Pharmacokinetic Evaluation 50 9.5 Health Economic Evaluations 50 9.6 Safety Evaluations 50 9.7 Safety Criteria 53 9.8 Other Exploratory Evaluations 54
Sample 1
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Use of Mechanical Assist. Intra-Aortic Balloon Pump or Ventricular Assist Devices (through Day 5) Information on the use of IABP will be obtained and recorded for all patients during index hospitalization and procedure. Similarly, the data on use of LVAD (left ventricular, right ventricular or biventricular) will also be collected. The endpoint applies to the use of mechanical assist (IABP, LVAD) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement. Note: Investigators are encouraged to use IABP or LVAD in patients presenting with LCOS following the start of surgery. The investigator must identify that the patient has presented with “poor cardiac function despite inotropic support and adequate fluid replacement” in the eCRF.
Sample 1

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