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

Recruiting now

Conditions studied: Cardiogenic Shock

In brief

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

Key facts

Study ID

NCT06645990

Run by

University Hospital, Montpellier

People needed

500

Starts

2010-01-01

Expected to finish

2025-01-30

Last updated by the study team

2024-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CHU Arnaud de Villeneuve — Montpellier, France (enrolling)

Full record on ClinicalTrials.gov

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