Effects of left ventricular unloading during VA ECMO support

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of left ventricular unloading using an intra-aortic balloon pump (IABP) on the success of weaning patients from venoarterial extracorporeal membrane oxygenation (VA ECMO) support in cases of cardiogenic shock. It is part of the REMAP ECMO platform, which aims to evaluate various management strategies for ECMO patients through a registry and embedded adaptive randomized trials. The study seeks to fill the knowledge gap regarding optimal ECMO management by providing high-quality evidence on the effectiveness of established interventions. The trial will compare outcomes between patients receiving VA ECMO with IABP support and those receiving VA ECMO alone.

Why it matters

Who can join: the full rules

Inclusion criteria for the registry backbone:

* Having received ECMO support for severe circulatory and/or respiratory insufficiency

Inclusion Criteria for the LV unloading trial domain (VA ECMO + IABP vs VA ECMO alone):

* Cardiogenic shock
* Having received VA ECMO support for severe circulatory (and respiratory insufficiency).
* Age ≥ 18 years
* Initiation of LV unloading (IABP or Impella) possible ≤ 8 hours after ECMO initiation

Exclusion criteria for the registry backbone

* Objection to participation in the registry by the patient and/or proxy
* VA ECMO usage confined to the period during surgery or another intervention (the VA ECMO was removed at the end of the intervention in the operation room).

Exclusion criteria for the LV unloading trial domain (VA ECMO + IABP vs VA ECMO alone)

* No (deferred) informed consent provided by the patient and/or proxy.
* Pregnancy
* ECMO usage confined to the period during surgery or another intervention (the ECMO was removed at the end of the intervention).
* Isolated right ventricular failure (e.g. due to pulmonary embolism).
* Left ventricular assist device (LVAD), Impella or IABP in situ.
* Ventricular septal defect or papillary muscle rupture as the cause of shock.
* Thoracic or abdominal aortic dissection.
* Moderate or severe aortic regurgitation
* Mechanical prosthesis in mitral valve position

Where it's running

• AZ Sint-Jan Brugge
  Bruges, Belgium Recruiting
• ZOL Genk
  Genk, Belgium Recruiting
• UZ Gent
  Ghent, Belgium Recruiting
• Erasmus Medical Center
  Rotterdam, South Holland, Netherlands Recruiting
• Olvg
  Amsterdam, Netherlands Recruiting
• Maastricht UMC
  Maastricht, Netherlands Recruiting

Study contacts

• Principal investigator: Christiaan Meuwese — Erasmus Medical Center
• Study coordinator: Myrthe van Steenwijk
• Email: m.p.j.vansteenwijk@erasmusmc.nl
• Phone: +31650162551

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Factors Influencing Outcomes in ECMO and Impella Patients

  This study tests whether metabolic and thyroid hormone changes help predict survival for adults on ECMO or Impella at a single Hungarian cardiac ICU.

  Recruiting Gottsegen National Cardiovascular Institute · Budapest · NCT07885618

• Evaluating a noninvasive tissue sensor to detect cardiogenic shock earlier in heart patients

  This pilot, noninvasive study tests whether the NIRSense wearable can help detect deterioration in adults with cardiogenic shock risk due to heart attack or heart failure.

  Recruiting NIRSense Inc. · Weston, Florida · NCT07825363

• Safety and Efficacy of an Extracorporeal Ventricular Assist System for Cardiogenic Shock

  This study tests whether an extracorporeal ventricular assist device can safely provide short-term heart support and help patients with cardiogenic shock or trouble weaning from bypass.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality · NCT07769528

• Left Ventricular Support and Advanced Monitoring in AMI–Cardiogenic Shock: Immediate Impella Use and PAC/Monitoring vs Standard Care

  In adults with heart attack-related cardiogenic shock, this trial tests whether using an Impella left ventricular assist device and/or protocolized pulmonary artery catheter monitoring improves survival compared with standard care.

  Recruiting Leipzig Heart Science gGmbH · Leipzig, Saxony · NCT07762560

• CRP Apheresis for infarct-related cardiogenic shock

  This study tests whether selectively removing C-reactive protein with apheresis, in addition to standard care, helps people with cardiogenic shock after a heart attack.

  Recruiting Leipzig Heart Science gGmbH · Leipzig, Saxony · NCT07687017

• Compare two ventilator modes in adults with cardiac ICU needs and invasive ventilation

  This pilot tests whether volume-controlled versus pressure-controlled ventilation can be safely used in adults with heart disease and respiratory failure who need invasive ventilation.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07656259

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.