Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation
EARLY-UNLOAD
1 other identifier
interventional
116
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedStudy Start
First participant enrolled
March 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedJanuary 12, 2024
January 1, 2024
1 year
February 24, 2021
January 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative incidence rate of all-cause death
Cumulative incidence rate of all-cause death
Up to 30 days
Secondary Outcomes (24)
Rate of all-cause death or left atrial septostomy in conventional approach group
Up to 30 days
Rate of left atrial septostomy in conventional approach group
Up to 30 days
Incidence rate of all-cause death during index admission
Up to 6 months
Cumulative incidence rate of cardiac death
Up to 30 days
Cumulative incidence rate of non-cardiac death
Up to 30 days
- +19 more secondary outcomes
Study Arms (2)
Early left atrial septostomy group
EXPERIMENTALEarly left atrial septostomy group will routinely receive left atrial septostomy within 12 hours after VA-ECMO implantation.
Conventional approach group
ACTIVE COMPARATORConventional 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \) Age more than 18 years old 2) Cardiogenic shock\* 3) Successful VA-ECMO implantation
- The definition of cardiogenic shock All these criteria should be met
- Systolic blood pressure \< 90 mmHg for 30 minutes, or needing inotrope or vasopressor to maintain systolic blood pressure \> or = 90 mmHg
- Pulmonary congestion on chest X-ray or increased left ventricular filling pressure by cardiac catheterization
- At least one criteria of organ dysfunction
- \- mental obtundation, clammy skin, oliguria, renal dysfunction, increased level of blood lactate
You may not qualify if:
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- VA-ECMO after open heart surgery
- VA-ECMO for the treatment of non-cardiac shock
- Severe bleeding\*
- Terminal malignancy
- Irreversible brain damage
- Pregnancy or lactation
- Hypovolemic shock due to definite bleeding cause
- Identifiable bleeding causes: gastrointestinal bleeding, hemothorax, traumatic bleeding, central nervous system hemorrhage, pulmonary hemorrhage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chonnam National University Hospital
Gwangju, South Korea
Related Publications (2)
Lim Y, Kim MC, Lee SH, Park S, Ahn JH, Hyun DY, Cho KH, Jung YH, Jeong IS, Ahn Y. Early left ventricular unloading after venoarterial extracorporeal membrane oxygenation: 1-year outcomes of the EARLY-UNLOAD randomized clinical trial. Eur Heart J Acute Cardiovasc Care. 2025 Apr 26;14(4):203-211. doi: 10.1093/ehjacc/zuae150.
PMID: 39749912DERIVEDKim MC, Lim Y, Lee SH, Shin Y, Ahn JH, Hyun DY, Cho KH, Sim DS, Hong YJ, Kim JH, Jeong MH, Jung YH, Jeong IS, Ahn Y. Early Left Ventricular Unloading or Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation: The EARLY-UNLOAD Randomized Clinical Trial. Circulation. 2023 Nov 14;148(20):1570-1581. doi: 10.1161/CIRCULATIONAHA.123.066179. Epub 2023 Oct 18.
PMID: 37850383DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Min Chul Kim, Professor
Chonnam National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 24, 2021
First Posted
March 1, 2021
Study Start
March 4, 2021
Primary Completion
March 14, 2022
Study Completion
October 31, 2023
Last Updated
January 12, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share