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Veno-arterial Extracorporeal Membrane Oxygenation Prior to Left Ventricular Assist Device Implantation. (LVAD-ECMO)

C

Central Hospital, Nancy, France

Status

Unknown

Conditions

Left Ventricular Assist Device
Heart Failure
Cardiogenic Shock
Extracorporeal Membrane Oxygenation

Treatments

Device: Left Ventricular Assist Device Implantation

Study type

Observational

Funder types

Other

Identifiers

NCT03583970
PSS2017/LVADECMO-FRITZ/YB

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Caroline Fritz, MD

Data sourced from clinicaltrials.gov

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