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RECRUITING
NCT06645990

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2010-01-01

Completion Date

2025-01-30

Last Updated

2024-10-17

Healthy Volunteers

No

Interventions

DEVICE

Impella

LV unloading with Impella (ECMELLA) before or within 24 h of ECMO initiation

DEVICE

IABP

LV unloading with IABP before or within 24 h of ECMO initiation

Locations (1)

CHU Arnaud de Villeneuve

Montpellier, France