Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06766006

ECMO LEft Ventricle UNloading Strategy

The present study is an International multicentric prospective observational cohort study. This will be an international research campaign to prospectively collect and analyze clinical data of all VA ECLS patients admitted to participating ICUs with a focus on LV venting modalities. The aims of the study are:

* To investigate the meaning of LV overload during veno-arterial (VA) extracorporeal life support; * To extensively describe the left ventricular (LV) unloading strategy during VA extracorporeal life support in a large prospective international cohort. * To compare different strategies to unload the left ventricular in terms of efficacy and outcomes;

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Shock, Cardiogenic Cardiac Arrest Cardiovascular Diseases Extracorporeal Membrane Oxygenation Complication Heart Arrest Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Vascular Diseases

Age range

1 day–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Cardiogenic shock and cardiac arrest are among the most lethal manifestations of acute cardiovascular disease, both burdened by extremely high in-hospital mortality rates. Extracorporeal life support is increasingly used either in adults or children with acutely impaired cardiac function refractory to conventional medical management, mainly in profound cardiogenic shock and refractory cardiac arrest. Veno-arterial extracorporeal life support works as a partial cardiopulmonary bypass draining the venous circulation directly into the systemic circulation. Veno-arterial extracorporeal life support provides biventricular support and provides respiratory gas exchange. One of the most important issues occurring during veno-arterial extracorporeal life support is the effect of the retrograde aortic flow which causes a marked increase in the left ventricular afterload with detrimental effects on myocardial performance. Left ventricular overload increases wall stress and myocardial oxygen consumption, jeopardizing ventricular recovery. Nowadays, different techniques are available for unloading the left chambers. However, despite the increasing worldwide experience with extracorporeal life support and the increased knowledge on the benefits of left ventricular unloading, the best veno-arterial extracorporeal life support configuration to achieve hemodynamic support, myocardial recovery, and left ventricular unloading, is still a matter of debate.

This is a prospective clinical study which is observational. The aims of the study are:

  • To extensively describe the left ventricular unloading strategy during veno-arterial extracorporeal life support in a large prospective international cohort, providing detailed information on indications, timing, type and modality among a wide spectrum of clinical conditions
  • To compare different strategies to unload the left ventricular in terms of efficacy and outcomes
  • To provide a common definition of left ventricular overload by collecting clinical, hemodynamic data and radiological information before and after unloading.

Demographics, clinical, instrumental and laboratory data prior and post implantation of veno-arterial extracorporeal life support will be collected. No interventions on top on the ones necessary as a standard of care will be taken.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing VA ECLS will be enrolled.

Exclusion criteria

  • Patients without VA ECMO will not be considered

Treatment and study plan

Venoarterial extracorporeal life support (VA ECLS) implant

Procedure

Implantation of venoarterial extracorporeal life support implant for refractory cardiogenic shock or cardiac arrest of any cause.

Primary outcomes

  1. In-hospital mortality

    Time frame: Day 30

    Death during hospital stay

  2. Overload detection, Echocardiographic parameters

    Time frame: Within 12 hours before the applied unloading technique

    Presence of left ventricle (LV) overload (defined as: aortic valve opening impairment and/or smoke like effect and/or LA distension and/or LV distension).

    The aforementioned criteria are defined as follows:

    • Aortic valve opening impairment: Aortic valve does not open every beat.
    • Smoke like effect: spontaneous echo contrast inside left ventricle chamber.
    • Left Atrium (LA) distension: male/female LA volume/body surface area (BSA)>=34 or increase>15%
    • LV distension: LV end-diastolic volume (ml) >150 ml, male; female LV end-diastolic volume (ml) >106 ml or increase>15%

  3. Unloading effectiveness, Echocardiographic parameters

    Time frame: 12 hours after the unloading technique implementation

    Echocardiographic qualitative parameters:

    • aortic valve opening (yes/no)
    • smoke like effect (yes/no)
    • LA distension (yes/no)
    • LV distension (yes/no)
    • inferior vena cava collapse/dilation (yes/no)
    • grade of mitral regurgitation (mild/moderatre/severe)

    Echocardiographic quantitative parameters:

    • LV end-diastolic diameter (mm)
    • LV end-diastolicvolume (ml)
    • LV end-systolic diameter (mm)
    • LV end-systolic volume(ml)
    • LA volume (ml)
    • E/E' septal and lateral (ratio, no unit of measurement )
    • systolic pulmonary artery pressure (mmHg)

Secondary outcomes

  1. Unloading Effectiveness, Qualitative echocardiographic parameters

    Time frame: 12 hours after the unloading technique implementation

    Unloading effectiveness, qualitative evaluation (yes/no) ( any of the following criteria: restored aortic valve opening (yes/no) and/or solved smoke like effect (yes/no) and/or reduced LA distension (yes/no) and/or reduced LV distension (yes/no) and/or decreased grade of mitral regurgitation)

  2. Major adverse events

    Time frame: Day 30

    Cerebral injury (stroke, transitory ischemic attack, intracranial hemorrhage and seizures by electroencephalogram), acute kidney injury requiring continuous renal replacement therapy, hemolysis (defined as increased free hemoglobin level, peripheral vascular damage, infections (defined as positive bacterial, fungal or viral culture or polymerase chain reaction test), coagulation disorders (either thrombosis or hemorrhage) and ECLS failure (pump or oxygenator failure, or both), liver and kidney organ function.

  3. Left Ventricular functional status

    Time frame: Day 30

    Left ventricle Ejection fraction (%)

  4. LVAD Implementation

    Time frame: Day 30

    LVAD implant

  5. Heart transplant

    Time frame: Day 30

    Heart transplant

  6. Neurological status at discharge

    Time frame: Day 30

    Cerebral Performance Category (CPC)

Other outcomes

  1. Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-diastolic diameter (mm)

    Time frame: 12 hours after the unloading technique implementation

    LV end-diastolic diameter (mm)

  2. Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-diastolic volume (ml)

    Time frame: 12 hours after the unloading technique implementation

    LV end-diastolic volume (ml)

  3. Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-systolic diameter (mm)

    Time frame: 12 hours after the unloading technique implementation

    LV end-systolic diameter (mm)

  4. Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-systolic volume(ml)

    Time frame: 12 hours after the unloading technique implementation

    LV end-systolic volume(ml)

  5. Unloading Effectiveness, Quantitative echocardiographic parameters, LA volume (ml)

    Time frame: 12 hours after the unloading technique implementation

    LA volume (ml)

  6. Unloading Effectiveness, Quantitative echocardiographic parameters, E/E' septal and lateral (ratio, no unit of measurement )

    Time frame: 12 hours after the unloading technique implementation

    E/E' septal and lateral (ratio, no unit of measurement )

  7. Unloading Effectiveness, Quantitative echocardiographic parameters, Systolic pulmonary artery pressure (mmHg)

    Time frame: 12 hours after the unloading technique implementation

    Systolic pulmonary artery pressure (mmHg)

Study contacts

Contact information is provided by the study sponsor or research team.

Paolo Meani, MD, PhD

CONTACT

[email protected]

43 38811067 ext. +31

Roberto Lorusso, MD,PhD

CONTACT

[email protected]

43 38811067 ext. +31

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • IRCCS Policlinico S. Donato

Registry information

Official study title

A Multicentric Left Ventricular Venting Strategy Comparison in Patients Receiving Venoarterial Extracorporeal Life Support

Acronym: ECMOLENS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.