Veno-arterial Extracorporeal Membrane Oxygenation Prior to Left Ventricular Assist Device Implantation.

• Conditions: Left Ventricular Assist Device; Cardiogenic Shock; Extracorporeal Membrane Oxygenation; Heart Failure

• Registration Number: NCT03583970
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-06-28
• Status Verified: 2018-07
• Study Start: 2018-07-05
• Study First Posted: 2018-07-12
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-17
• Primary Completion: 2019-06-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6-month hospital discharge after LVAD implantation	6 month after LVAD implantation	6-month hospital discharge after LVAD implantation

Secondary Outcome Measures

Name	Time	Method
Mortality rate	up to six month after LVAD implantation	Six month mortality rate after LVAD implantation
ICU discharge	up to six month after LVAD implantation	Days until ICU discharge after LVAD implantation
Quality of life	up to six month after LVAD implantation	ADL and IADL scale

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Nancy, France