Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 4:46 PM
Study NCT ID:
NCT06766006
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2023-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECMO LEft Ventricle UNloading Strategy
Sponsor:
Maastricht University Medical Center
Organization:
Study Overview
Official Title:
A Multicentric Left Ventricular Venting Strategy Comparison in Patients Receiving Venoarterial Extracorporeal Life Support
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECMOLENS
Brief Summary:
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:
* To investigate the meaning of LV overload during veno-arterial (VA) extracorporeal life support;
* To extensively describe the left ventricular (LV) unloading strategy during VA extracorporeal life support in a large prospective international cohort.
* To compare different strategies to unload the left ventricular in terms of efficacy and outcomes;
* To investigate the meaning of LV overload during veno-arterial (VA) extracorporeal life support;
* To extensively describe the left ventricular (LV) unloading strategy during VA extracorporeal life support in a large prospective international cohort.
* To compare different strategies to unload the left ventricular in terms of efficacy and outcomes;
Detailed Description:
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:
* To extensively describe the left ventricular unloading strategy during veno-arterial extracorporeal life support in a large prospective international cohort, providing detailed information on indications, timing, type and modality among a wide spectrum of clinical conditions
* To compare different strategies to unload the left ventricular in terms of efficacy and outcomes
* To provide a common definition of left ventricular overload by collecting clinical, hemodynamic data and radiological information before and after unloading.
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.
This is a prospective clinical study which is observational. The aims of the study are:
* To extensively describe the left ventricular unloading strategy during veno-arterial extracorporeal life support in a large prospective international cohort, providing detailed information on indications, timing, type and modality among a wide spectrum of clinical conditions
* To compare different strategies to unload the left ventricular in terms of efficacy and outcomes
* To provide a common definition of left ventricular overload by collecting clinical, hemodynamic data and radiological information before and after unloading.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: