Early LA Venting During Venoaterial ECMO Support (NCT03740711) | Clinical Trial Compass
CompletedNot Applicable
Early LA Venting During Venoaterial ECMO Support
South Korea60 participantsStarted 2018-12-12
Plain-language summary
The EVOLVE-ECMO(Early Left Atrial Venting Versus Conventional Treatment For Left VEntricular Decompression During Venoarterial ExtraCorporeal Membrane Oxygenation Support) study is a randomized controlled trial to evaluate the prognostic effect of early LA venting(when detect B-line on serial lung ultrasound) on weaning VA-ECMO support in refractory CS who receive VA-ECMO support. The aim of EVOLVE-ECMO trial is to test the hypothesis that early LA venting would result in a significant reduction in failure of weaning ECMO support in refractory CS.
Who can participate
Age range
19 Years – 79 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:
* Subject was \> 18 years of age.
* Subjects who underwent successful VA-ECMO support
* Subjects with refractory cardiogenic shock who had pulmonary edema confirmed by chest X ray or lung sonogram.
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion Criteria:
* subject was \<80 years of age
* Pregnant and/or lactate women
* Subjects who underwent VA-ECMO after recent open heart surgery
* Subjects who underwent VA-ECMO after non-cardiogenic arrest(trauma, hypothermia, submersion, drug overdose, asphyxia, intracranial hemorrhage etc)
* Severe bleeding tendency
* Terminal malignancy
* Known severe irreversible brain damage
* Subject was unable to provide written informed consent or participate.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.