Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645990
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Early Left Ventricular unLoading by Impella vs Intra-aortic Balloon Pump
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Left Ventricular unLoading by Impella ECMELLA or Intra-aortic Balloon Pump for Cardiogenic Shock in Patients on VA-ECMO
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELLIPSE1
Brief Summary:
Over the past decade VA-ECMO has become the main mechanical support for cardiogenic shock CS unresponsive to medical therapy However recent studies failed to show any significant survival benefit at 30 days compared to medical treatment for myocardial infarction-related CS This could be due to the complications of VA-ECMO such as LV overload and increased LV distension which can hinder heart recovery
To address this early LV unloading using devices like IABP or Impella ECMELLA may help by reducing LV wall stress and oxygen consumption However these techniques carry risks and their benefit is still unclear A randomized trial is needed to compare these approaches but observational studies are also contributing to understanding the best strategies
To address this early LV unloading using devices like IABP or Impella ECMELLA may help by reducing LV wall stress and oxygen consumption However these techniques carry risks and their benefit is still unclear A randomized trial is needed to compare these approaches but observational studies are also contributing to understanding the best strategies
Detailed Description:
Over the last decade veno-arterial extracorporeal membrane oxygenation VA-ECMO has become the mechanical circulatory support of choice for cardiogenic shock CS refractory to medical treatment VA-ECMO allows to supplement cardiac function until myocardium recovers or in bridge to long-term left ventricular assist device LVAD or to heart transplant However recent randomized controlled trials RCT and meta-analysis have failed to demonstrate any benefit of VA-ECMO in terms of 30-day survival compared with optimal medical treatment in CS related to myocardial infarction
Reasons for these disappointing results are multifactorial The associated risk of temporary mechanical circulatory support t-MCS-related complications might counterbalance any hemodynamic benefit In addition to hemorrhagic and ischemic complications the significant myocardial impact due to VA-ECMO drawbacks should not be overlooked Indeed while VA-ECMO restores systemic perfusion it can also lead to an increase in left ventricle LV loading conditions Although LV distension is not consistently observed recent publications strongly suggest that the origin of LV overload seems to be multifactorial and contributes partially to cardiac remodeling through the modulation of cardioprotective cellular pathways resulting in reduced cardiomyocyte apoptosis Furthermore peripheral VA-ECMO affects myocardial contractility and increases myocardial work potential energy stroke work and pressure-volume area particularly at native low blood flow
Thus cardiac recovery may be compromised and weaning from VA-ECMO delayed This vicious cycle affects the patients overall prognosis as delayed and possibly failure of VA-ECMO weaning and may convert the initial medical strategy of recovery towards heart transplantation or LVAD To optimize the chance of VA-ECMO weaning early LV unloading may be a good therapeutic option It aims at increasing coronary flow directly and indirectly by improving sub-endocardial myocardial perfusion through decreasing LV wall stress and myocardial oxygen consumption Currently 2 techniques are mainly used the intra-aortic balloon pump IABP and the microaxial flow pump as Impella device familly ECMELLA These invasive techniques carry risks of bleeding and thromboembolic complications and the benefitrisk ratio of their use for myocardial recovery is not clearly established
A few retrospective studies suggest that early left ventricular unloading during VA-ECMO could improve prognosis In the absence of RCT the choice of the technique Impella or IABP is mainly driven by center practice A multicenter randomized clinical trial would be the best choice to address this question However due to the acute poor prognosis of these patients 50 of early deaths reliable preliminary data about the expected effect size are necessary to design the most efficient clinical trial Recent epidemiologic developments of observational studies the emulated trials allow a better control of immortal time bias and indication bias
This innovative multicenter study will compare the effectiveness and safety of LV unloading by Impella ECMELLA versus IABP in terms of survival with myocardial recovery in patients with refractory CS
Reasons for these disappointing results are multifactorial The associated risk of temporary mechanical circulatory support t-MCS-related complications might counterbalance any hemodynamic benefit In addition to hemorrhagic and ischemic complications the significant myocardial impact due to VA-ECMO drawbacks should not be overlooked Indeed while VA-ECMO restores systemic perfusion it can also lead to an increase in left ventricle LV loading conditions Although LV distension is not consistently observed recent publications strongly suggest that the origin of LV overload seems to be multifactorial and contributes partially to cardiac remodeling through the modulation of cardioprotective cellular pathways resulting in reduced cardiomyocyte apoptosis Furthermore peripheral VA-ECMO affects myocardial contractility and increases myocardial work potential energy stroke work and pressure-volume area particularly at native low blood flow
Thus cardiac recovery may be compromised and weaning from VA-ECMO delayed This vicious cycle affects the patients overall prognosis as delayed and possibly failure of VA-ECMO weaning and may convert the initial medical strategy of recovery towards heart transplantation or LVAD To optimize the chance of VA-ECMO weaning early LV unloading may be a good therapeutic option It aims at increasing coronary flow directly and indirectly by improving sub-endocardial myocardial perfusion through decreasing LV wall stress and myocardial oxygen consumption Currently 2 techniques are mainly used the intra-aortic balloon pump IABP and the microaxial flow pump as Impella device familly ECMELLA These invasive techniques carry risks of bleeding and thromboembolic complications and the benefitrisk ratio of their use for myocardial recovery is not clearly established
A few retrospective studies suggest that early left ventricular unloading during VA-ECMO could improve prognosis In the absence of RCT the choice of the technique Impella or IABP is mainly driven by center practice A multicenter randomized clinical trial would be the best choice to address this question However due to the acute poor prognosis of these patients 50 of early deaths reliable preliminary data about the expected effect size are necessary to design the most efficient clinical trial Recent epidemiologic developments of observational studies the emulated trials allow a better control of immortal time bias and indication bias
This innovative multicenter study will compare the effectiveness and safety of LV unloading by Impella ECMELLA versus IABP in terms of survival with myocardial recovery in patients with refractory CS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None