Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membr… (NCT04775472) | Clinical Trial Compass
CompletedNot Applicable
Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation
South Korea116 participantsStarted 2021-03-04
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. VA-ECMO after open heart surgery
. VA-ECMO for the treatment of non-cardiac shock
. Severe bleeding\*
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared doing a left atrial septostomy early versus the conventional approach in patients on VA-ECMO for cardiogenic shock — given my specific situation, is one of these strategies more appropriate for me, and why?
2Since this trial has already completed and was measuring all-cause death as its main outcome, has my doctor seen the results, and what do those findings suggest about whether early left atrial septostomy is beneficial or risky compared to the standard approach?
3VA-ECMO is already a very intensive intervention — can my doctor explain what a left atrial septostomy involves on top of that, and what additional risks it might carry based on what this trial found?
4This trial is listed as phase 'NA,' which suggests it may have been more of a comparative study than a traditional drug trial — does that affect how much confidence my doctor has in applying its findings to my care?
5Are there patients in cardiogenic shock for whom this early septostomy approach would NOT be recommended, and does my doctor think my condition would have made me a candidate based on the type of patients enrolled in this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.