An observational study in Shock, Cardiogenic, Cardiac Arrest and Extracorporeal Membrane Oxygenation Complication, sponsored by Maastricht University Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 1 Day to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by Maastricht University Medical Center · Observational
The present study is an International multicentric prospective observational cohort study. This will be an international research campaign to prospectively collect and analyze clinical data of all VA ECLS patients admitted to participating ICUs with a focus on LV venting modalities. The aims of the study are:
Cardiogenic shock and cardiac arrest are among the most lethal manifestations of acute cardiovascular disease, both burdened by extremely high in-hospital mortality rates. Extracorporeal life support is increasingly used either in adults or children with acutely impaired cardiac function refractory to conventional medical management, mainly in profound cardiogenic shock and refractory cardiac arrest. Veno-arterial extracorporeal life support works as a partial cardiopulmonary bypass draining the venous circulation directly into the systemic circulation. Veno-arterial extracorporeal life support provides biventricular support and provides respiratory gas exchange. One of the most important issues occurring during veno-arterial extracorporeal life support is the effect of the retrograde aortic flow which causes a marked increase in the left ventricular afterload with detrimental effects on myocardial performance. Left ventricular overload increases wall stress and myocardial oxygen consumption, jeopardizing ventricular recovery. Nowadays, different techniques are available for unloading the left chambers. However, despite the increasing worldwide experience with extracorporeal life support and the increased knowledge on the benefits of left ventricular unloading, the best veno-arterial extracorporeal life support configuration to achieve hemodynamic support, myocardial recovery, and left ventricular unloading, is still a matter of debate.
This is a prospective clinical study which is observational. The aims of the study are:
Demographics, clinical, instrumental and laboratory data prior and post implantation of veno-arterial extracorporeal life support will be collected. No interventions on top on the ones necessary as a standard of care will be taken.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's planned enrollment of 500 is above the median of 200 across 383 observational studies indexed under Heart Arrest.
Browse Heart Arrest studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients affected by cardiogenic shock or cardiac arrest independent of etiology supported with VA ECLS.
Exclusion Criteria:
All patients undergoing VA ECLS will be enrolled. Patients without VA ECLS will not be considered. Centers will follow their standard protocols for the management of patients on VA ECLS.
Procedure: Venoarterial extracorporeal life support (VA ECLS) implant
Implantation of venoarterial extracorporeal life support implant for refractory cardiogenic shock or cardiac arrest of any cause.
In-hospital mortality
Death during hospital stay
Time frame: Day 30
Overload detection, Echocardiographic parameters
Presence of left ventricle (LV) overload (defined as: aortic valve opening impairment and/or smoke like effect and/or LA distension and/or LV distension). The aforementioned criteria are defined as follows: * Aortic valve opening impairment: Aortic valve does not open every beat. * Smoke like effect: spontaneous echo contrast inside left ventricle chamber. * Left Atrium (LA) distension: male/female LA volume/body surface area (BSA)\>=34 or increase\>15% * LV distension: LV end-diastolic volume (ml) \>150 ml, male; female LV end-diastolic volume (ml) \>106 ml or increase\>15%
Time frame: Within 12 hours before the applied unloading technique
Unloading effectiveness, Echocardiographic parameters
Echocardiographic qualitative parameters: * aortic valve opening (yes/no) * smoke like effect (yes/no) * LA distension (yes/no) * LV distension (yes/no) * inferior vena cava collapse/dilation (yes/no) * grade of mitral regurgitation (mild/moderatre/severe) Echocardiographic quantitative parameters: * LV end-diastolic diameter (mm) * LV end-diastolicvolume (ml) * LV end-systolic diameter (mm) * LV end-systolic volume(ml) * LA volume (ml) * E/E' septal and lateral (ratio, no unit of measurement ) * systolic pulmonary artery pressure (mmHg)
Time frame: 12 hours after the unloading technique implementation
Unloading Effectiveness, Qualitative echocardiographic parameters
Unloading effectiveness, qualitative evaluation (yes/no) ( any of the following criteria: restored aortic valve opening (yes/no) and/or solved smoke like effect (yes/no) and/or reduced LA distension (yes/no) and/or reduced LV distension (yes/no) and/or decreased grade of mitral regurgitation)
Time frame: 12 hours after the unloading technique implementation
Major adverse events
Cerebral injury (stroke, transitory ischemic attack, intracranial hemorrhage and seizures by electroencephalogram), acute kidney injury requiring continuous renal replacement therapy, hemolysis (defined as increased free hemoglobin level, peripheral vascular damage, infections (defined as positive bacterial, fungal or viral culture or polymerase chain reaction test), coagulation disorders (either thrombosis or hemorrhage) and ECLS failure (pump or oxygenator failure, or both), liver and kidney organ function.
Time frame: Day 30
Left Ventricular functional status
Left ventricle Ejection fraction (%)
Time frame: Day 30
LVAD Implementation
LVAD implant
Time frame: Day 30
Heart transplant
Heart transplant
Time frame: Day 30
Neurological status at discharge
Cerebral Performance Category (CPC)
Time frame: Day 30
Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-diastolic diameter (mm)
LV end-diastolic diameter (mm)
Time frame: 12 hours after the unloading technique implementation
Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-diastolic volume (ml)
LV end-diastolic volume (ml)
Time frame: 12 hours after the unloading technique implementation
Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-systolic diameter (mm)
LV end-systolic diameter (mm)
Time frame: 12 hours after the unloading technique implementation
Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-systolic volume(ml)
LV end-systolic volume(ml)
Time frame: 12 hours after the unloading technique implementation
Unloading Effectiveness, Quantitative echocardiographic parameters, LA volume (ml)
LA volume (ml)
Time frame: 12 hours after the unloading technique implementation
Unloading Effectiveness, Quantitative echocardiographic parameters, E/E' septal and lateral (ratio, no unit of measurement )
E/E' septal and lateral (ratio, no unit of measurement )
Time frame: 12 hours after the unloading technique implementation
Unloading Effectiveness, Quantitative echocardiographic parameters, Systolic pulmonary artery pressure (mmHg)
Systolic pulmonary artery pressure (mmHg)
Time frame: 12 hours after the unloading technique implementation
Plan to share: Undecided
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