Cardiogenic ShockEARLY-UNLOADNCT04775472
Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation
A study testing Early left atrial septostomy within 12 hours after VA-ECMO implantation and Selective left atrial septostomy in people with Cardiogenic Shock, run by Chonnam National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Early left atrial septostomy within 12 hours after VA-ECMO implantation and Selective left atrial septostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Mar 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) 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
Who cannot join
- <!-- -->
- VA-ECMO after open heart surgery
- VA-ECMO for the treatment of non-cardiac shock
- Severe bleeding*
- Terminal malignancy
- Irreversible brain damage
Show all 10Show fewer
- Pregnancy or lactation
- The definition of severe bleeding Hemoglobin decrease after VA-ECMO or cannulation site bleeding is not a exclusion criteria
- Hypovolemic shock due to definite bleeding cause
- Identifiable bleeding causes: gastrointestinal bleeding, hemothorax, traumatic bleeding, central nervous system hemorrhage, pulmonary hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Controlled Study
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.
Read the detailed description
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.
- Conditions
- Cardiogenic Shock
- Being tested
- Early left atrial septostomy within 12 hours after VA-ECMO implantation, Selective left atrial septostomy
- Keywords
- Extracorporeal membrane oxygenation, Myocardial Infarction, Heart Diseases, Cardiovascular Diseases, Coronary Disease
- Medical subject headings
- Shock, Cardiogenic, Myocardial Infarction, Heart Diseases, Cardiovascular Diseases, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early left atrial septostomy within 12 hours after VA-ECMO implantationProcedure or surgery
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.
Selective left atrial septostomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Early left atrial septostomy group | Experimental | Early left atrial septostomy group will routinely receive left atrial septostomy within 12 hours after VA-ECMO implantation. Receives: Procedure: Early left atrial septostomy within 12 hours after VA-ECMO implantation |
| Conventional approach group | Active comparator | 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. Receives: Procedure: Selective left atrial septostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence rate of all-cause death
Cumulative incidence rate of all-cause death
Measured: Up to 30 days
Secondary outcomes (24)
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
Measured: Up to 30 days
Rate of left atrial septostomy in conventional approach group
Rate of left atrial septostomy in conventional approach group
Measured: Up to 30 days
Incidence rate of all-cause death during index admission
Incidence rate of all-cause death during index admission
Measured: Up to 6 months
Cumulative incidence rate of cardiac death
Cumulative incidence rate of cardiac death
Measured: Up to 30 days
Cumulative incidence rate of non-cardiac death
Cumulative incidence rate of non-cardiac death
Measured: Up to 30 days
Weaning rate from venoarterial extracorporeal membrane oxygenation during index admission
Weaning rate from venoarterial extracorporeal membrane oxygenation during index admission
Measured: 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
Measured: Up to 6 months
Weaning rate from mechanical ventilator during index admission
Weaning rate from mechanical ventilator during index admission
Measured: Up to 6 months
Intensive care unit length of stay during index admission
Intensive care unit length of stay during index admission
Measured: Up to 6 months
Hospital length of stay
Hospital length of stay
Measured: Up to 6 months
Lactate normalization rate
Lactate normalization rate
Measured: Up to 30 days
Lactate clearance rate
Lactate clearance rate
Measured: Up to 30 days
Rate of renal replacement therapy during index admission
Rate of renal replacement therapy during index admission
Measured: Up to 6 months
Rate of limb ischemia during index admission
Rate of limb ischemia during index admission
Measured: Up to 6 months
Rate of infection during index admission
Rate of infection during index admission
Measured: Up to 6 months
Rate of transient ischemic attack or stroke during index admission
Rate of transient ischemic attack or stroke during index admission
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 30 days
Cumulative incidence rate of all-cause death
Cumulative incidence rate of all-cause death
Measured: Up to 12 months
Cumulative incidence rate of cardiac death
Cumulative incidence rate of cardiac death
Measured: Up to 12 months
Cumulative incidence rate of non-cardiac death
Cumulative incidence rate of non-cardiac death
Measured: Up to 12 months
Re-hospitalization rate due to heart failure
Re-hospitalization rate due to heart failure
Measured: 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
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start4 Mar 2021
- Primary completion14 Mar 2022
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Chul Kim, Chonnam National University Hospital
- Investigators
- Min Chul Kim, Professor, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775472
- Sponsor's protocol ID
- CNUH-2020-390
- Acronym
- EARLY-UNLOAD
- Status last verified
- Jan 2024
- First submitted
- 24 Feb 2021
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39749912Kim 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.
PubMed 37850383
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04775472
- Acronym / sponsor ID
- EARLY-UNLOAD / CNUH-2020-390
- Conditions
- Cardiogenic Shock
- Keywords
- Extracorporeal membrane oxygenation, Myocardial Infarction, Heart Diseases, Cardiovascular Diseases, Coronary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early left atrial septostomy group | Experimental | Procedure: Early left atrial septostomy within 12 hours after VA-ECMO implantationEarly left atrial septostomy group will routinely receive left atrial septostomy within 12 hours after VA-ECMO implantation. |
| Conventional approach group | Active comparator | Procedure: Selective left atrial septostomyConventional 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1) 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
Key exclusion criteria (10 listed)
- <!-- -->
- The definition of severe bleeding Hemoglobin decrease after VA-ECMO or cannulation site bleeding is not a exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early left atrial septostomy within 12 hours after VA-ECMO implantationEarly 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. | Procedure or surgery | Early left atrial septostomy group |
| Selective left atrial septostomyLeft 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. | Procedure or surgery | Conventional approach group |
Primary outcome
Cumulative incidence rate of all-cause death
Time frame: Up to 30 days
Cumulative incidence rate of all-cause death
24 secondary outcomes
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
Time frame: Up to 30 days
Incidence rate of all-cause death during index admission
Time frame: Up to 6 months
Cumulative incidence rate of cardiac death
Time frame: Up to 30 days
Cumulative incidence rate of non-cardiac death
Time frame: Up to 30 days
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
Time frame: Up to 6 months
Weaning rate from mechanical ventilator during index admission
Time frame: Up to 6 months
Intensive care unit length of stay during index admission
Time frame: Up to 6 months
Hospital length of stay
Time frame: Up to 6 months
Lactate normalization rate
Time frame: Up to 30 days
Lactate clearance rate
Time frame: Up to 30 days
Rate of renal replacement therapy during index admission
Time frame: Up to 6 months
Rate of limb ischemia during index admission
Time frame: Up to 6 months
Rate of infection during index admission
Time frame: Up to 6 months
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
Time frame: Up to 6 months
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
Time frame: Up to 30 days
Cumulative incidence rate of all-cause death
Time frame: Up to 12 months
Cumulative incidence rate of cardiac death
Time frame: Up to 12 months
Cumulative incidence rate of non-cardiac death
Time frame: Up to 12 months
Re-hospitalization rate due to heart failure
Time frame: Up to 12 months
All-cause death or re-hospitalization rate due to heart failure
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Derived from this study: PubMed 39749912Lim 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.
- Derived from this study: PubMed 37850383Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Chul Kim, Professor principal investigator
Chonnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early left atrial septostomy within 12 hours after VA-ECMO implantation and Selective left atrial septostomy in people with Cardiogenic Shock, run by Chonnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence rate of all-cause death (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04775472, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.