Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05913622

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

Led by Erasmus Medical Center · Updated on 2025-12-17

430

Participants Needed

14

Research Sites

260 weeks

Total Duration

On this page

Sponsors

E

Erasmus Medical Center

Lead Sponsor

D

Dutch Heart Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Having received ECMO support for severe circulatory and/or respiratory insufficiency
  • Cardiogenic shock
  • Having received VA ECMO support for severe circulatory (and respiratory) insufficiency
  • Age 18 years or older
  • Left ventricular unloading (IABP or Impella) can be initiated within 8 hours after ECMO start
Not Eligible

You will not qualify if you...

  • Objecting to participation in the registry by patient or proxy
  • VA ECMO used only during surgery or intervention and removed afterwards
  • No or deferred informed consent provided by patient or proxy
  • Pregnancy
  • Isolated right ventricular failure (e.g., pulmonary embolism)
  • Existing left ventricular assist device (LVAD), Impella or IABP in place
  • Ventricular septal defect or papillary muscle rupture causing shock
  • Thoracic or abdominal aortic dissection
  • Moderate or severe aortic regurgitation
  • Mechanical prosthesis in mitral valve position

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

AZ Sint-Jan Brugge

Bruges, Belgium

Actively Recruiting

2

ZOL Genk

Genk, Belgium

Actively Recruiting

3

UZ Gent

Ghent, Belgium

Actively Recruiting

4

Amphia hospital

Breda, North Brabant, Netherlands, 4818 CK

Not Yet Recruiting

5

Catharina hospital

Eindhoven, North Brabant, Netherlands, 5623 EJ

Not Yet Recruiting

6

Amsterdam University Medical Center

Amsterdam, North Holland, Netherlands, 1105 AZ

Not Yet Recruiting

7

Leiden University Medical Center

Leiden, South Holland, Netherlands, 2333 ZA

Not Yet Recruiting

8

Erasmus Medical Center

Rotterdam, South Holland, Netherlands, 3015 GD

Actively Recruiting

9

Haga ziekenhuis

The Hague, South Holland, Netherlands, 2545 AA

Not Yet Recruiting

10

Antonius hospital

Nieuwegein, Utrecht, Netherlands, 3435 CM

Not Yet Recruiting

11

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands, 3584 CX

Not Yet Recruiting

12

OLVG

Amsterdam, Netherlands

Actively Recruiting

13

Maastricht UMC

Maastricht, Netherlands

Actively Recruiting

14

Radboud UMC

Nijmegen, Netherlands

Actively Recruiting

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Research Team

M

Myrthe van Steenwijk

CONTACT

C

Christiaan Meuwese

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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