Early Left Ventricular unLoading by Impella (ECMELLA) or Intra-aortic Balloon Pump for Cardiogenic Shock in Patients on VA-ECMO

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Arnaud de Villeneuve
RECRUITING
Montpellier
Contact Information
Primary
Aurore UGHETTO, MD
a-ughetto@chu-montpellier.fr
0033622054893
Backup
Clément DELMAS, MD, PhD
delmas.clement@chu-toulouse.fr
0033673147951
Time Frame
Start Date: 2010-01-01
Estimated Completion Date: 2025-01-30
Participants
Target number of participants: 500
Treatments
ECMELLA group
VA-ECMO + Impella implemented before or within 24 h of ECMO initiation
ECMO+IABP group
VA-ECMO + IABP implemented before or within 24h of ECMO initiation
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov