Clinical trial NCT03583970: Veno-arterial Extracorporeal Membrane Oxygenation Prior to Left Ventricular Assist Device Implantation.
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiogenic Shock
Heart Failure
Extracorporeal Membrane Oxygenation
Left Ventricular Assist Device
Keywords: Left Ventricular Assist Device
Extracorporeal Membrane Oxygenation
Refractory Cardiogenic Shock
Heart Failure
Cardiovascular diseases
Myocardial Infarction
Myocardial Ischemia
Shock
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients between 01.01.2013 and 31.12.2017 in the participating centers implanted with LVAD during VA-ECMO therapy for refractory cardiogenic shock.

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.


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

Primary outcomes:
measure: 6-month hospital discharge after LVAD implantation
timeFrame: 6 month after LVAD implantation
Secondary outcomes:
measure: Mortality rate
timeFrame: up to six month after LVAD implantation
measure: ICU discharge
timeFrame: up to six month after LVAD implantation
measure: Quality of life
timeFrame: up to six month after LVAD implantation
Other outcomes:
measure: Hemodynamic Failure
timeFrame: Before LVAD implantation - up to 28 day - up to 6 month
measure: Cardiogenic failure
timeFrame: Before LVAD implantation - up to 28 day - up to 6 month
measure: Cardio-circulatory failure
timeFrame: Before LVAD implantation - up to 28 day - up to 6 month
measure: Renal failure
timeFrame: Before LVAD implantation - up to 28 day - up to 6 month
measure: Hepatic failure
timeFrame: Before LVAD implantation - up to 28 day - up to 6 month
measure: Thrombosis complication
timeFrame: Before LVAD implantation - up to 28 day - up to 6 month
measure: Haemorragic complication
timeFrame: Before LVAD implantation - up to 28 day - up to 6 month
measure: Respiratory failure
timeFrame: Before LVAD implantation - up to 28 day - up to 6 month
measure: Neurological failure
timeFrame: Before LVAD implantation - up to 28 day - up to 6 month
measure: Infection complication
timeFrame: Before LVAD implantation - up to 28 day - up to 6 month
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: CHRU Nancy
name: Bruno Levy, MD-PhD
role: STUDY_CHAIR
References: