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Clinical Trials/NCT03583970
NCT03583970
Unknown
Not Applicable

Veno-arterial Extracorporeal Membrane Oxygenation Support Prior to Left Ventricular Assist Device Implantation : Initial Patients Characteristics and 6 Month Follow-up, a Retrospective Study (2013-2017) (LVAD-ECMO)

Central Hospital, Nancy, France1 site in 1 country100 target enrollmentJuly 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiogenic Shock
Sponsor
Central Hospital, Nancy, France
Enrollment
100
Locations
1
Primary Endpoint
6-month hospital discharge after LVAD implantation
Last Updated
7 years ago

Overview

Brief Summary

Cardiogenic shock is an uncommun pathology with a high mortatily rate around 45%. Veno arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary extracorporeal assist device which restore an adequate blood flow when a circulatory failure occures. VA-ECMO main indication is refractory cardiogenic shock whatever the etiology. Current medical care of terminal cardiac failure includes use of long-term mechanical circulatory support devices (MCSD) such as Left Ventricular Assist Device (LVAD). LVAD therapy may lead to heart transplant (bridge to transplantation), to recovery (bridge to recovery) or to permanent implantation (destination therapy). Few patients with refractory cardiogenic shock treated with VA-ECMO may secondarily need a long term MCSD with LVAD.

LVAD long-term heart assist showed interesting survival rate when implantation occured (71% after 2 years follow-up and 45% after 4 years follow-up) out of acute heart failure situation. There are only few datas concerning LVAD implantion during refractory cardiogenic shock, with a mortality between 20 to 50% in different studies.

In this way, in comparaison of current few datas on the subject of LVAD implantation under VA-ECMO, the investigators (15 french-speacking centers) would retrospectively describe a large population.

Registry
clinicaltrials.gov
Start Date
July 5, 2018
End Date
December 1, 2020
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

Caroline FRITZ

MD

Central Hospital, Nancy, France

Eligibility Criteria

Inclusion Criteria

  • Veno-arterial ExtraCorporeal Membrane Oxygenation prior to left ventricular assist device implantation.
  • Veno-arterial ExtraCorporeal Membrane Oxygenation at the left ventricular assist device implantation operative time

Exclusion Criteria

  • ExtraCorporeal Membrane Oxygenation weaving before left ventricular assist device implantation.
  • Cardiac assist devices other than Veno-arterial ExtraCorporeal Membrane Oxygenation

Outcomes

Primary Outcomes

6-month hospital discharge after LVAD implantation

Time Frame: 6 month after LVAD implantation

6-month hospital discharge after LVAD implantation

Secondary Outcomes

  • Mortality rate(up to six month after LVAD implantation)
  • ICU discharge(up to six month after LVAD implantation)
  • Quality of life(up to six month after LVAD implantation)

Study Sites (1)

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