Skip to main content
Clinical Trials/NCT04480151
NCT04480151
Completed
Not Applicable

ExtraCorporeal Life Support (ECLS) Versus IMPELLA™ Pump as Bridge to Left Ventricular Assist Device

University Hospital, Bordeaux5 sites in 1 country92 target enrollmentJanuary 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiogenic Shock
Sponsor
University Hospital, Bordeaux
Enrollment
92
Locations
5
Primary Endpoint
Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8 at 30 days after the LVAD implantation
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

In this retrospective observational multicenter study the authors tested the hypothesis that the use of IMPELLA™ pump as bridge to bridge, by giving the opportunity of active rehabilitation, should improve patient's outcomes after the implantation of Left Ventricular Assist Device (LVAD).

Detailed Description

End stage heart failure patients admitted in Intensive Care Unit (ICU) for refractory cardiogenic shock requiring short-term mechanical circulatory support as a bridge to a long-term LVAD might benefit from early mobilization and rehabilitation with IMPELLA™ inserted via the axillary artery. The aim of this study is to compare the early rehabilitation and outcomes after LVAD implantation between patients previously treated by IMPELLA™ or ExtraCorporeal Life Support (ECLS)

Registry
clinicaltrials.gov
Start Date
January 20, 2021
End Date
April 21, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients supported with IMPELLA™ or ECLS for refractory cardiogenic shock as a bridge to long duration LVAD

Exclusion Criteria

  • Patient refusing to give access to their medical chart
  • Guardianship and curactorship
  • Deprived of liberty
  • short term mechanical circulatory system weaned before LVAD implantation

Outcomes

Primary Outcomes

Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8 at 30 days after the LVAD implantation

Time Frame: Day 30 after Left Ventricular Assist Device (LVAD) implantation

Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8) at 30 days after the LVAD implantation

Secondary Outcomes

  • Organ dysfunction before LVAD implantation(The day before LVAD implantation)
  • SOFA score(Day 7 post LVAD implantation)
  • length of stay(up to hospital discharge (not more than 6 months after LVAD implantation))
  • Complication and rehabilitation under Short-term Mechanical Circulatory support(The day of Left Ventricular Assist Device (LVAD) implantation)
  • complication Under LVAD(The day of Intensive Care Unit (ICU) discharge)
  • Vital status(6 months after LVAD implantation)

Study Sites (5)

Loading locations...

Similar Trials