Early Left Ventricular unLoading by Impella vs Intra-aortic Balloon Pump (ELLIPSE1)

October 15, 2024 updated by: University Hospital, Montpellier

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Over the last decade, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has become the mechanical circulatory support of choice for cardiogenic shock (CS) refractory to medical treatment. VA-ECMO allows to supplement cardiac function until myocardium recovers, or in bridge to long-term left ventricular assist device (LVAD) or to heart transplant. However, recent randomized controlled trials (RCT) and meta-analysis have failed to demonstrate any benefit of VA-ECMO in terms of 30-day survival compared with optimal medical treatment in CS related to myocardial infarction.

Reasons for these disappointing results are multifactorial. The associated risk of temporary mechanical circulatory support (t-MCS)-related complications might counterbalance any hemodynamic benefit. In addition to hemorrhagic and ischemic complications, the significant myocardial impact due to VA-ECMO drawbacks should not be overlooked. Indeed, while VA-ECMO restores systemic perfusion, it can also lead to an increase in left ventricle (LV) loading conditions. Although LV distension is not consistently observed, recent publications strongly suggest that the origin of LV overload seems to be multifactorial and contributes partially to cardiac remodeling through the modulation of cardioprotective cellular pathways, resulting in reduced cardiomyocyte apoptosis. Furthermore, peripheral VA-ECMO affects myocardial contractility and increases myocardial work (potential energy, stroke work, and pressure-volume area), particularly at native low blood flow.

Thus, cardiac recovery may be compromised and weaning from VA-ECMO delayed. This vicious cycle affects the patients overall prognosis, as delayed and possibly failure of VA-ECMO weaning and may convert the initial medical strategy of recovery towards heart transplantation or LVAD. To optimize the chance of VA-ECMO weaning, early LV unloading may be a good therapeutic option. It aims at increasing coronary flow directly and, indirectly, by improving sub-endocardial myocardial perfusion through decreasing LV wall stress and myocardial oxygen consumption. Currently, 2 techniques are mainly used, the intra-aortic balloon pump (IABP) and the microaxial flow pump as Impella device familly (ECMELLA). These invasive techniques carry risks of bleeding and thromboembolic complications, and the benefit/risk ratio of their use for myocardial recovery is not clearly established.

A few retrospective studies suggest that early left ventricular unloading during VA-ECMO could improve prognosis. In the absence of RCT, the choice of the technique (Impella or IABP) is mainly driven by center practice. A multicenter randomized clinical trial would be the best choice to address this question. However, due to the acute poor prognosis of these patients (50% of early deaths), reliable preliminary data about the expected effect size are necessary to design the most efficient clinical trial. Recent epidemiologic developments of observational studies, the emulated trials, allow a better control of immortal time bias and indication bias.

This innovative multicenter study will compare the effectiveness and safety of LV unloading by Impella (ECMELLA) versus IABP in terms of survival with myocardial recovery in patients with refractory CS

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Montpellier, France, 34295
        • Recruiting
        • CHU Arnaud de Villeneuve

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All 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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ECMELLA group
VA-ECMO + Impella implemented before or within 24 h of ECMO initiation
Device: Impella
LV unloading with Impella (ECMELLA) before or within 24 h of ECMO initiation
ECMO+IABP group
VA-ECMO + IABP implemented before or within 24h of ECMO initiation
Device: IABP
LV unloading with IABP before or within 24 h of ECMO initiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial recovery
Time Frame: from start of hospitalization until hospital discharge assessed up to 3 month
Hospital Survival without chronic mechanical circulatory support (LVAD) and heart transplantation.
from start of hospitalization until hospital discharge assessed up to 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early mortality
Time Frame: from start of hospitalization until hospital discharge assessed up to 3 month
In-hospital all-cause mortality
from start of hospitalization until hospital discharge assessed up to 3 month
Adverse events related to LV unloading technics
Time Frame: from start of hospitalization until hospital discharge assessed up to 3 month
Arterial thromboembolic events; Hemorrhagic events (RBC transfusion); Hemolysis; Bacteremia; Infection of the device insertion site or the device itself
from start of hospitalization until hospital discharge assessed up to 3 month
Duration of mechanical ventilation
Time Frame: from start of hospitalization until hospital discharge assessed up to 3 month
Total duration of invasive mechanical ventilation
from start of hospitalization until hospital discharge assessed up to 3 month
Duration of temporary MCS support
Time Frame: from start of hospitalization until hospital discharge assessed up to 3 month
Total duration of t-MCS
from start of hospitalization until hospital discharge assessed up to 3 month
Lengh of stay
Time Frame: from start of hospitalization until hospital discharge assessed up to 3 month
Total and in intensive care unit lenght of stay
from start of hospitalization until hospital discharge assessed up to 3 month
Cardiac long-term project
Time Frame: from start of hospitalization until hospital discharge assessed up to 3 month
Rate and % of patients with myocardial recovery, ventricular assist device or/and heart transplantation
from start of hospitalization until hospital discharge assessed up to 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Aurore UGHETTO, MD, Montpellier University Hospital, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

January 1, 2023

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

October 1, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-06-079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiogenic Shock

Clinical Trials on Impella

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe