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Early Left Ventricular unLoading by Impella vs Intra-aortic Balloon Pump

Recruitingn/aAges 18 Years - anyAllUniversity Hospital, Montpellier
NCT06645990 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Over the past decade, VA-ECMO has become the main mechanical support for cardiogenic shock (CS) unresponsive to medical therapy. However, recent studies failed to show any significant survival benefit at 30 days compared to medical treatment for myocardial infarction-related CS. This could be due to the complications of VA-ECMO, such as LV overload and increased LV distension, which can hinder heart recovery. To address this, early LV unloading using devices like IABP or Impella (ECMELLA) may help by reducing LV wall stress and oxygen consumption. However, these techniques carry risks, and their benefit is still unclear. A randomized trial is needed to compare these approaches, but observational studies are also contributing to understanding the best strategies

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patients (more than or =18 years) admitted for cardiogenic shock supported by ECMO+ IABP or ECMELLA between January 1, 2010, and December 31, 2023 Exclusion Criteria: * Ongoing extra-corporeal CardioPulmonary Resuscitation (eCPR) at time of ECMO implantation * Cardiogenic shock with previous prolonged continuous cardiopulmonary resuscitation (CPR) more than 30 minutes * Acute irreversible neurological injury * Previous known severe chronic cardiomyopathy (LVEF less than 25%) or awaiting heart transplantation or LVAD implantation * Contraindication to the implantation of an Impella or IABP * Mechanical complications of myocardial infarction * Moribund patient (SAPS more than 90) * Previous known severe chronic renal or hepatic failure * Age less than18 years
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What it tests

  • Impella
  • IABP
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Where

1 site
CHU Arnaud de Villeneuve
Montpellier, France
🤝 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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