Effects of left ventricular unloading during VA ECMO support

Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation (REMAP ECMO) - Left Ventricular Unloading Study

This study is testing whether using an intra-aortic balloon pump along with VA ECMO support can help patients with heart failure recover better than just using VA ECMO alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 430 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Erasmus Medical Center (Academic / other)
• Locations: 14 sites (Bruges and 13 other locations)
• Trial ID: NCT05913622 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older experiencing cardiogenic shock who have received VA ECMO support for severe circulatory and/or respiratory insufficiency.

Not a fit: Patients who are pregnant or those whose ECMO usage is limited to surgical procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve weaning success rates from VA ECMO, potentially reducing mortality in patients with cardiogenic shock.

How similar studies have performed: Other studies have explored various management strategies in ECMO, but this specific approach of LV unloading in the context of VA ECMO is novel and aims to provide new insights.

Eligibility criteria

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 this trial is running

Bruges and 13 other locations

• AZ Sint-Jan Brugge — Bruges, Belgium (Recruiting)
• ZOL Genk — Genk, Belgium (Recruiting)
• UZ Gent — Ghent, Belgium (Recruiting)
• Amphia hospital — Breda, North Brabant, Netherlands (Not_yet_recruiting)
• Catharina hospital — Eindhoven, North Brabant, Netherlands (Not_yet_recruiting)
• Amsterdam University Medical Center — Amsterdam, North Holland, Netherlands (Not_yet_recruiting)
• Leiden University Medical Center — Leiden, South Holland, Netherlands (Not_yet_recruiting)
• Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
• Haga ziekenhuis — The Hague, South Holland, Netherlands (Not_yet_recruiting)
• Antonius hospital — Nieuwegein, Utrecht, Netherlands (Not_yet_recruiting)
• University Medical Center Utrecht — Utrecht, Utrecht, Netherlands (Not_yet_recruiting)
• Olvg — Amsterdam, Netherlands (Recruiting)
• Maastricht UMC — Maastricht, Netherlands (Recruiting)
• Radboud UMC — Nijmegen, Netherlands (Recruiting)

Study contacts

• Principal investigator: Christiaan Meuwese — Erasmus Medical Center
• Study coordinator: Myrthe van Steenwijk

Conditions Cardiogenic Shock; Left ventricular unloading; Venoarterial ExtraCorporeal Membrane Oxygenation; Cardiogenic shock