An interventional study of Early left atrial septostomy within 12 hours after VA-ECMO implantation and Selective left atrial septostomy in Cardiogenic Shock, sponsored by Chonnam National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-01-12.
Sponsored by Chonnam National University Hospital · Not applicable, Interventional, and Treatment
The use of venoarterial-extracorporeal membrane oxygenation(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 pressure(LVEDP), 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 Objectives:
To determine the effect of early left atrial septostomy versus conventional approach(left atrial septostomy only in cases of significant changes due to left ventricular end-diastolic pressure increase) in patients who received venoarterial-extracorporeal membrane oxygenation(VA-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 pump(IABP), 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 pressure(LVEDP), 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.
277 studies on the registry are indexed under Shock, Cardiogenic; 127 are open to participants now.
This study's enrollment of 116 is above the median of 80 across 127 interventional studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →Chonnam National University Hospital is the lead sponsor of 70 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The definition of cardiogenic shock All these criteria should be met
At least one criteria of organ dysfunction
Exclusion Criteria:
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The definition of severe bleeding Hemoglobin decrease after VA-ECMO or cannulation site bleeding is not a exclusion criteria
Early left atrial septostomy group will routinely receive left atrial septostomy within 12 hours after VA-ECMO implantation.
Procedure: Early left atrial septostomy within 12 hours after VA-ECMO implantation
Conventional approach group will receive left atrial septostomy in cases of deleterious effect of increased LVEDP after VA-ECMO implantation, such as refractory pulmonary edema, abnormal opening of aortic valve, left ventricular dilatation, refractory ventricular tachycardia or fibrillation.
Procedure: Selective left atrial septostomy
Early left atrial septostomy group will routinely receive left atrial septostomy within 12 hours after VA-ECMO implantation. Left atrial septostomy will be done using percutaneous technique.
Left atrial septostomy will be done in cases of deleterious effect of increased LVEDP after VA-ECMO implantation, such as refractory pulmonary edema, abnormal opening of aortic valve, left ventricular dilatation, refractory ventricular tachycardia or fibrillation.
Cumulative incidence rate of all-cause death
Cumulative incidence rate of all-cause death
Time frame: Up to 30 days
Rate of all-cause death or left atrial septostomy in conventional approach group
Rate of all-cause death or left atrial septostomy in conventional approach group
Time frame: Up to 30 days
Rate of left atrial septostomy in conventional approach group
Rate of left atrial septostomy in conventional approach group
Time frame: Up to 30 days
Incidence rate of all-cause death during index admission
Incidence rate of all-cause death during index admission
Time frame: Up to 6 months
Cumulative incidence rate of cardiac death
Cumulative incidence rate of cardiac death
Time frame: Up to 30 days
Cumulative incidence rate of non-cardiac death
Cumulative incidence rate of non-cardiac death
Time frame: Up to 30 days
Weaning rate from venoarterial extracorporeal membrane oxygenation during index admission
Weaning rate from venoarterial extracorporeal membrane oxygenation during index admission
Time frame: Up to 6 months
Rate of disappearance of pulmonary edema on chest X-ray during index admission
Rate of disappearance of pulmonary edema on chest X-ray during index admission
Time frame: Up to 6 months
Weaning rate from mechanical ventilator during index admission
Weaning rate from mechanical ventilator during index admission
Time frame: Up to 6 months
Intensive care unit length of stay during index admission
Intensive care unit length of stay during index admission
Time frame: Up to 6 months
Hospital length of stay
Hospital length of stay
Time frame: Up to 6 months
Lactate normalization rate
Lactate normalization rate
Time frame: Up to 30 days
Lactate clearance rate
Lactate clearance rate
Time frame: Up to 30 days
Rate of renal replacement therapy during index admission
Rate of renal replacement therapy during index admission
Time frame: Up to 6 months
Rate of limb ischemia during index admission
Rate of limb ischemia during index admission
Time frame: Up to 6 months
Rate of infection during index admission
Rate of infection during index admission
Time frame: Up to 6 months
Rate of transient ischemic attack or stroke during index admission
Rate of transient ischemic attack or stroke during index admission
Time frame: Up to 6 months
Rate of BARC bleeding type 3 or 5 during index admission
Rate of BARC bleeding type 3 or 5 during index admission
Time frame: Up to 6 months
Rate of bridge to ventricular assist device or heart transplantation during index admission
Rate of bridge to ventricular assist device or heart transplantation during index admission
Time frame: Up to 6 months
Rate of major vascular injury or cardiac tamponade during left atrial septostomy
Rate of major vascular injury or cardiac tamponade during left atrial septostomy
Time frame: Up to 30 days
Cumulative incidence rate of all-cause death
Cumulative incidence rate of all-cause death
Time frame: Up to 12 months
Cumulative incidence rate of cardiac death
Cumulative incidence rate of cardiac death
Time frame: Up to 12 months
Cumulative incidence rate of non-cardiac death
Cumulative incidence rate of non-cardiac death
Time frame: Up to 12 months
Re-hospitalization rate due to heart failure
Re-hospitalization rate due to heart failure
Time frame: Up to 12 months
All-cause death or re-hospitalization rate due to heart failure
All-cause death or re-hospitalization rate due to heart failure
Time frame: Up to 12 months
Plan to share: No
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Chonnam National University Hospital