Ireland
--:--IST
Recruiting Not applicable

A Study on the Effects of Left Ventricular Unloading in the Setting of VA ECMO Support

NCT05913622 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2023-06-08
Last updated
2025-12-17

Condition(s) studied

Cardiogenic Shock

Investigational drug(s) / intervention(s)

Intra-aortic balloon pump

Intra-aortic balloon pump: An IABP is placed percutaneously into the thoracic aorta and supports the heart through synchronized inflation and deflation of a balloon.

Study summary

REMAP ECMO is a registry based platform in which multiple response adaptive randomized clinical trials (trial domains) will be embedded. These trial domains will, in a perpetual way, study the effects of a range of patient management strategies which aim to improve VA ECMO weaning success. A first trial domain will address the effects of left ventricular (LV) unloading through intra-aortic balloon pumping on weaning succes in VA ECMO supported patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • ECMO weaning success — 30 days
    Proportion of patients successfully weaned from VA ECMO at 30 days being defined by; a) being alive, b) without ECMO, IABP or Impella support, and c) not having received a heart transplantation or left ventricular assist device (LVAD).
  • Physiological substudy: End diastolic volume — within 24 hours after ECMO initiation
    End diastolic volume as assessed by echocardiography

Trial sites (14)

FacilityCityRegionStatus
AZ Sint-Jan Brugge Bruges Belgium Recruiting
ZOL Genk Genk Belgium Recruiting
UZ Gent Ghent Belgium Recruiting
Amphia hospital Breda North Brabant Not Yet Recruiting
Catharina hospital Eindhoven North Brabant Not Yet Recruiting
Amsterdam University Medical Center Amsterdam North Holland Not Yet Recruiting
Leiden University Medical Center Leiden South Holland Not Yet Recruiting
Erasmus Medical Center Rotterdam South Holland Recruiting
Haga ziekenhuis The Hague South Holland Not Yet Recruiting
Antonius hospital Nieuwegein Utrecht Not Yet Recruiting
University Medical Center Utrecht Utrecht Utrecht Not Yet Recruiting
OLVG Amsterdam Netherlands Recruiting
Maastricht UMC Maastricht Netherlands Recruiting
Radboud UMC Nijmegen Netherlands Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05913622 on ClinicalTrials.gov ↗ ← All trials in Belgium