Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04775472
Status:
COMPLETED
Last Update Posted:
2024-01-12
First Post:
2021-02-24
Brief Title:
Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation
Sponsor:
Chonnam National University Hospital
Organization:
Chonnam National University Hospital
Study Overview
Official Title:
Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-01
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:
EARLY-UNLOAD
Brief Summary:
The use of venoarterial-extracorporeal membrane oxygenationVA-ECMO was associated with lower in-hospital mortality in patients with cardiogenic shock However VA-ECMO has a deleterious effect for hemodynamics It can increase left ventricular end-diastolic pressureLVEDP followed by left ventricular dilatation abnormal opening of aortic valve and jeopardizes of myocardial recovery Therefore several methods have been used to reduce LVEDP Among these left atrial septostomy is effective but less invasive than surgical left ventricular unloading However there is few data regarding this issue Therefore the investigators will evaluate the effect of routine early left atrial septostomy in patients with VA-ECMO for the treatment of cardiogenic shock
Detailed Description:
Study Objectives
To determine the effect of early left atrial septostomy versus conventional approachleft atrial septostomy only in cases of significant changes due to left ventricular end-diastolic pressure increase in patients who received venoarterial-extracorporeal membrane oxygenationVA-ECMO for the treatment of cardiogenic shock
Study Background
Cardiogenic shock is due to myocardial dysfunction from multifactorial causes which has high mortality The treatment for cardiogenic shock includes early coronary revascularization inotropes vasopressors or mechanical circulatory support such as intraaortic balloon pumpIABP VA-ECMO However the routine use of IABP is not recommended for the treatment of cardiogenic shock in recent guidelines VA-ECMO can be easily implanted and can maintain high cardiac output In several studies The use of VA-ECMO was associated with lower in-hospital mortality in patients with cardiogenic shock
However VA-ECMO has a deleterious effect for hemodynamics It can increase left ventricular end-diastolic pressureLVEDP followed by left ventricular dilatation abnormal opening of aortic valve and jeopardizes of myocardial recovery Therefore several methods have been used to reduce LVEDP Among these left atrial septostomy is effective but less invasive than surgical left ventricular unloading However there is few data regarding this issue Therefore the investigators will evaluate the effect of routine early left atrial septostomy in patients with VA-ECMO for the treatment of cardiogenic shock
Study Hypothesis
Early routine left atrial septostomy for left heart unloading is superior compared to conventional approach to reduce in-hospital mortality and the duration of VA-ECMO
To determine the effect of early left atrial septostomy versus conventional approachleft atrial septostomy only in cases of significant changes due to left ventricular end-diastolic pressure increase in patients who received venoarterial-extracorporeal membrane oxygenationVA-ECMO for the treatment of cardiogenic shock
Study Background
Cardiogenic shock is due to myocardial dysfunction from multifactorial causes which has high mortality The treatment for cardiogenic shock includes early coronary revascularization inotropes vasopressors or mechanical circulatory support such as intraaortic balloon pumpIABP VA-ECMO However the routine use of IABP is not recommended for the treatment of cardiogenic shock in recent guidelines VA-ECMO can be easily implanted and can maintain high cardiac output In several studies The use of VA-ECMO was associated with lower in-hospital mortality in patients with cardiogenic shock
However VA-ECMO has a deleterious effect for hemodynamics It can increase left ventricular end-diastolic pressureLVEDP followed by left ventricular dilatation abnormal opening of aortic valve and jeopardizes of myocardial recovery Therefore several methods have been used to reduce LVEDP Among these left atrial septostomy is effective but less invasive than surgical left ventricular unloading However there is few data regarding this issue Therefore the investigators will evaluate the effect of routine early left atrial septostomy in patients with VA-ECMO for the treatment of cardiogenic shock
Study Hypothesis
Early routine left atrial septostomy for left heart unloading is superior compared to conventional approach to reduce in-hospital mortality and the duration of VA-ECMO
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None