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Early Preventive Left Ventricle Unloading After VA-ECMO for Refractory Cardiogenic Shock

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly being used worldwide to treat severe cardiogenic shock. The survival rate of these patients has increased in the last decade, reaching 45-50% for patients with acute myocardial infarction (AMI), the most frequent indication of the technique, 50-60% for patients with end-stage dilated cardiomyopathy bridged to heart transplantation or long-term left ventricle assist device (LVAD) surgery, 60-70% for fulminant myocarditis, while it remains lower for post-cardiotomy cardiogenic shock (25-35%) and after cardiac arrest (20-40%). However, peripherally inserted VA-ECMO increases left ventricular (LV) afterload, that may lead to poorer clinical outcomes by fostering left ventricular distension, blood stagnation, aortic valve closure, all of which increasing pulmonary congestion and the need for mechanical ventilation and

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patient on peripheral femoro-femoral VA ECMO for severe Cardiogenic shock for ≤24h 2. Initiation of LV unloading possible within 12 hours after randomization. 3. Consent obtained from a close relative or surrogate. Should such a person be absent, eligible patients will be randomized according to the specifications of emergency consent and the patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow. 4. Social security registration (AME excluded) Exclusion Criteria: 1. Age \<18 years 2. Pregnancy 3. Onset of VA-ECMO \>24 h 4. Overt pulmonary edema despite optimization of patient's management (titration of ECMO blood flow, inotropes, non-invasive mechanical ventilation with PEEP, diuretics or hemofiltration) requiring urgent LV unloading 5. ECMO for massive pulmonary embolism or primary RV failure 6. ECMO after heart transplant 7. ECMO after LVAD surgery 8. Resuscitation \>30 minutes before ECMO (cumulative low-flow time), except if the patient has fully recover consciousness at the time of randomization. 9. ECMO for refractory cardiac arrest (E-CPR) 10. Grade 3-4 aortic regurgitation 11. Mechanical complication of acute myocardial infarction (massive mitral regurgitation, pericardium drainage required, septal ventricular defect) 12. Patient moribund on the day of randomization 13. Cerebral deficit with fixed dilated pupils or Irreversible neurological pathology 14. Other severe concomitant disease with limited life expectancy \<1 year 15. Patient has a durable ventricular assist device, an IABP or another temporary mechanical circulatory support (other than ECMO) prior to enrollment. 16. Severe peripheral artery disease or previous aortic or ilio-femoral surgery precluding IABP or IMPELLA insertion.
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What it tests

  • Early Left Ventricle unloading
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Where

12 sites
CHU Clermont-Ferrand - Site Gabriel Montpied
Clermont-Ferrand, France
Henri Mondor
Créteil, France
Hôpital Cardiologique
Lille, France
APHP - hôpital Pitié-Salpêtrière
Paris, France
APHP - hôpital Pitié-Salpêtrière
Paris, France
APHP - hôpital Pitié-Salpêtrière
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital du Pontchaillou
Rennes, France

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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