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

NCT06645990 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-10-17

No results posted yet for this study

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

Conditions

  • Cardiogenic Shock

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

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Aurore UGHETTO, MD · Montpellier University Hospital, France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-01
Primary Completion
2023-01-01
Completion
2025-01-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06645990 on ClinicalTrials.gov