An observational study in Cardiogenic Shock, Heart Failure and Extracorporeal Membrane Oxygenation, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-17.
Sponsored by Central Hospital, Nancy, France · Observational
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Veno-arterial extracorporeal membrane oxygenation prior to left ventricular assist device implantation : initial patients characteristics and 6 Month Follow-up
6-month hospital discharge after LVAD implantation
6-month hospital discharge after LVAD implantation
Time frame: 6 month after LVAD implantation
Mortality rate
Six month mortality rate after LVAD implantation
Time frame: up to six month after LVAD implantation
ICU discharge
Days until ICU discharge after LVAD implantation
Time frame: up to six month after LVAD implantation
Quality of life
ADL and IADL scale
Time frame: up to six month after LVAD implantation
Hemodynamic Failure
Amount of Norepinephrine infused
Time frame: Before LVAD implantation - up to 28 day - up to 6 month
Cardiogenic failure
Amount of inotrope infused
Time frame: Before LVAD implantation - up to 28 day - up to 6 month
Cardio-circulatory failure
ECLS assistance
Time frame: Before LVAD implantation - up to 28 day - up to 6 month
Renal failure
Worst KDIGO stage
Time frame: Before LVAD implantation - up to 28 day - up to 6 month
Hepatic failure
Worst values of PT/bilirubin/ AST and ALT
Time frame: Before LVAD implantation - up to 28 day - up to 6 month
Thrombosis complication
Thrombosis event
Time frame: Before LVAD implantation - up to 28 day - up to 6 month
Haemorragic complication
Haemorragic event
Time frame: Before LVAD implantation - up to 28 day - up to 6 month
Respiratory failure
Ventilation assistance
Time frame: Before LVAD implantation - up to 28 day - up to 6 month
Neurological failure
neurological sequelae
Time frame: Before LVAD implantation - up to 28 day - up to 6 month
Infection complication
documented infection
Time frame: Before LVAD implantation - up to 28 day - up to 6 month
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France