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

Heart Failure Clinical Trial

— LVAD-ECMO  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03583970
• Other study ID #: PSS2017/LVADECMO-FRITZ/YB
• Status: Recruiting
• Start date: July 5, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2018
• Source: Central Hospital, Nancy, France
• Contact: Caroline Fritz, MD
• Phone: +3383157379
• Email: fritzcaro[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Extracorporeal Membrane Oxygenation
• Heart Failure
• Left Ventricular Assist Device
• Shock, Cardiogenic

Intervention

Device:
• Left Ventricular Assist Device Implantation
Veno-arterial extracorporeal membrane oxygenation prior to left ventricular assist device implantation : initial patients characteristics and 6 Month Follow-up

Locations

Country	Name	City	State
France	CHRU Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemodynamic Failure	Amount of Norepinephrine infused	Before LVAD implantation - up to 28 day - up to 6 month
Other	Cardiogenic failure	Amount of inotrope infused	Before LVAD implantation - up to 28 day - up to 6 month
Other	Cardio-circulatory failure	ECLS assistance	Before LVAD implantation - up to 28 day - up to 6 month
Other	Renal failure	Worst KDIGO stage	Before LVAD implantation - up to 28 day - up to 6 month
Other	Hepatic failure	Worst values of PT/bilirubin/ AST and ALT	Before LVAD implantation - up to 28 day - up to 6 month
Other	Thrombosis complication	Thrombosis event	Before LVAD implantation - up to 28 day - up to 6 month
Other	Haemorragic complication	Haemorragic event	Before LVAD implantation - up to 28 day - up to 6 month
Other	Respiratory failure	Ventilation assistance	Before LVAD implantation - up to 28 day - up to 6 month
Other	Neurological failure	neurological sequelae	Before LVAD implantation - up to 28 day - up to 6 month
Other	Infection complication	documented infection	Before LVAD implantation - up to 28 day - up to 6 month
Primary	6-month hospital discharge after LVAD implantation	6-month hospital discharge after LVAD implantation	6 month after LVAD implantation
Secondary	Mortality rate	Six month mortality rate after LVAD implantation	up to six month after LVAD implantation
Secondary	ICU discharge	Days until ICU discharge after LVAD implantation	up to six month after LVAD implantation
Secondary	Quality of life	ADL and IADL scale	up to six month after LVAD implantation