Actively Recruiting
Early Left Ventricular unLoading by Impella vs Intra-aortic Balloon Pump
Led by University Hospital, Montpellier · Updated on 2024-10-17
500
Participants Needed
1
Research Sites
786 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Early Left Ventricular unLoading by Impella vs Intra-aortic Balloon Pump
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Admitted for cardiogenic shock supported by ECMO plus IABP or Impella (ECMELLA) between January 1, 2010, and December 31, 2023
You will not qualify if you...
- Ongoing extracorporeal cardiopulmonary resuscitation (eCPR) at ECMO implantation
- Cardiogenic shock with previous continuous CPR longer than 30 minutes
- Acute irreversible neurological injury
- Known severe chronic cardiomyopathy (LVEF less than 25%) or awaiting heart transplant or LVAD implantation
- Contraindication to implantation of Impella or IABP
- Mechanical complications of myocardial infarction
- Moribund patient with SAPS score over 90
- Known severe chronic kidney or liver failure
- Age under 18 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU Arnaud de Villeneuve
Montpellier, France, 34295
Actively Recruiting
Research Team
A
Aurore UGHETTO, MD
CONTACT
C
Clément DELMAS, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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