Evaluation of Predictive Factors for Right Ventriculaire Dysfunction (NCT04596982) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Predictive Factors for Right Ventriculaire Dysfunction
France18 participantsStarted 2021-04-09
Plain-language summary
An observational study of patients in cardiogenic shock under veno-arterial ECMO is designed to describe the clinical, ultrasound and hemodynamic parameters of these patients and to establish a predictive score for right-sided dysfunction in a patient within 48 hours of ECMO withdrawal after placement of IMPELLA®.
Who can participate
Age range
18 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
. \- Patient over 18 years of age
. \- Patient under ECMO hospitalized in the medical intensive care unit or the surgical intensive care unit of the Groupement hospitalier Pitié-Salpêtrière, not weaned from ECMO, in whom it was decided at the multidisciplinary collegial meeting on assistance-transplantation to set up an IMPELLA before the implantation of left monoventricular assistance.
. \- Patient who received informed information about the study and did not express opposition to participation in the research.
. \- Patient affiliated or entitled to a French social security system -
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.
What they're measuring
1
Absence of right heart failure or failure to withdraw ECMO due to right heart failure after placement of IMPELLA®.
Timeframe: Within 48 hours of ECMO withdrawal after placement of IMPELLA®