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Cardiogenic ShockREMAP ECMONCT05913622

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

A study testing Intra-aortic balloon pump in people with Cardiogenic Shock, run by Erasmus Medical Center at 14 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiogenic Shock
What is being tested?
Intra-aortic balloon pump
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
430 participants
Where
14 sitesin 2 countries
Study dates
8 Jun 2023to 1 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 12Show fewer
  • 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

Trial locations and contacts

14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Myrthe van Steenwijk contact

+31650162551

m.p.j.vansteenwijk@erasmusmc.nl

Christiaan Meuwese contact

+31631135752

c.meuwese@erasmusmc.nl

14 sites in 2 countries

Netherlands11 sites, 11 recruiting

  • Amsterdam University Medical Center

    Amsterdam, North Holland, 1105 AZ

    Not yet recruiting

  • OLVG

    Amsterdam

    Recruiting

  • Amphia hospital

    Breda, North Brabant, 4818 CK

    Not yet recruiting

  • Catharina hospital

    Eindhoven, North Brabant, 5623 EJ

    Not yet recruiting

  • Leiden University Medical Center

    Leiden, South Holland, 2333 ZA

    Not yet recruiting

  • Maastricht UMC

    Maastricht

    Recruiting

  • Antonius hospital

    Nieuwegein, Utrecht, 3435 CM

    Not yet recruiting

  • Radboud UMC

    Nijmegen

    Recruiting

  • Erasmus Medical Center

    Rotterdam, South Holland, 3015 GD

    Myrthe V Steenwijk, +31650162551, m.p.j.vansteenwijk@erasmusmc.nl

    Recruiting

  • Haga ziekenhuis

    The Hague, South Holland, 2545 AA

    Not yet recruiting

  • University Medical Center Utrecht

    Utrecht, Utrecht, 3584 CX

    Not yet recruiting

Other trials in Netherlands

Belgium3 sites, 3 recruiting

  • AZ Sint-Jan Brugge

    Bruges

    Recruiting

  • ZOL Genk

    Genk

    Recruiting

  • UZ Gent

    Ghent

    Recruiting

Other trials in Belgium

About this study

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

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.

Read the detailed description

ExtraCorporeal Membrane Oxygenation (ECMO) is increasingly used but remains associated with high weaning failure- and mortality- rates. This seems in part attributable to a knowledge gap on how to properly manage ECMO and its related therapies as current knowledge and treatment protocols are based on observational studies and expert opinions. The "Randomized Embedded Multifactorial Adaptive Platform in ECMO" (REMAP ECMO) study was developed to study, in an efficient and randomized way, different ECMO related patient management issues and will consist of two parts:

  1. A patient registry that will serve for quality monitoring and observational studies of ECMO patients being treated in participating centers.
  2. Embedded within the registry, multiple response adaptive randomized clinical trials (trial domains) which aim to evaluate the effectiveness of a range of therapeutic interventions on ECMO weaning success. These interventions all have in common that they are all already used in ECMO care but their use depends on center and/or doctors preferences as no high quality (randomized) evidence guiding their indication, timing and management exists.
  • LV unloading trial A first trial domain to be initiated within the REMAP ECMO platform will address the effects of left ventricular (LV) unloading, through application of an intra-aortic balloon pump (IABP), on weaning success in the setting of venoarterial (VA) ECMO. The rationale of this trial domain is based on the increase in LV loading conditions, as induced by VA ECMO, which could lead to pulmonary edema, intracardiac thrombosis and even death. These serious sequelae could possibly be prevented by adding IABP as adjunct to VA ECMO therapy.
  • Physiological substudy on IABP as adjunct to V-A ECMO

A nested physiological observational substudy within the ongoing REMAP ECMO RCT, using the trial arms where patients are randomized between receiving V-A ECMO with or without IABP in the Erasmus Medical Center Rotterdam. The substudy aims to evaluate the physiological effects of IABP in conjunction with V-A ECMO on respiratory and hemodynamic parameters. The substudy consists of two parts:

  1. Microcirculation and Macrocirculation: This part investigates the impact of IABP on both microcirculation and macrocirculation in the setting of V-A ECMO.
  2. PEEP as an Unloading Modality: This part examines the effect of Positive End-Expiratory Pressure (PEEP) as an unloading modality during a decremental PEEP trial in patients receiving V-A ECMO, either with or without IABP.

Endpoints in both substudies that can be assessed blindly will be evaluated by an assessor who is blinded to the assigned treatment arm and the objectives of the substudy

Being tested
Intra-aortic balloon pump
Keywords
Left ventricular unloading, Venoarterial ExtraCorporeal Membrane Oxygenation (VA ECMO), Cardiogenic shock
Medical subject headings
Shock, Cardiogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intra-aortic balloon pumpDevice

    Also called IABP

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

Study groups in NCT05913622
Study groupRoleWhat they receive
IABP unloading armExperimentalThis group of patients will receive an intra-aortic balloon pump (IABP) as an adjunct to VA ECMO support. When allocated to the IABP unloading arm, patients must receive an IABP within 8 hours after VA ECMO initiation.
Receives: Device: Intra-aortic balloon pump
ECMO alone armNo interventionThis group of patients will receive VA ECMO support without left ventricular unloading device after randomization.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ECMO weaning success

    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).

    Measured: 30 days

  2. Physiological substudy: End diastolic volume

    End diastolic volume as assessed by echocardiography

    Measured: within 24 hours after ECMO initiation

Secondary outcomes (22)

  1. Treatment failure

    The proportion of patients in whom LV unloading therapy was escalated. Escalation is defined by the insertion of an IABP (only in the VA ECMO alone arm), or Impella or left vent (IABP unloading arm or VA ECMO alone arm).

    Measured: During ECMO support

  2. 30 day, 90 day and 1 year mortality

    Mortality rate at 30 days, 90 days and 1 year after ECMO initiation

    Measured: 30 days, 90 days and 1 year after ECMO initiation

  3. ECMO support duration

    The duration of ECMO support in days

    Measured: Until 30 days after ECMO initiation

  4. Major bleeding events

    The occurrence of major bleeding events (fatal, in a critical area (intracranial, intraspinal, or intraocular), requiring intervention (coiling or surgery) and/or transfusion of ≥3 packed cells) until 30 days after VA ECMO initiation.

    Measured: Until 30 days after ECMO initiation

  5. Unplanned surgical or catheter based intervention of the leg(s)

    Unplanned surgical or catheter based intervention of the leg(s) in which ECMO and/or IABP or Impella was inserted until 30 days after ECMO initiation.

    Measured: Until 30 days after ECMO initiation

  6. Time to lactate normalization

    Time to lactate normalization (<2 mmol/L).

    Measured: Until 30 days after ECMO initiation

  7. Time to first negative net fluid balance

    Time to first negative net fluid balance (calculated per 24 hours).

    Measured: Until 30 days after ECMO initiation

  8. The occurrence of continuous venovenous hemofiltration initiation during ECMO support

    The occurrence of continuous venovenous hemofiltration (dialysis) (CVVH(D)) initiation during ECMO support.

    Measured: Until 30 days after ECMO initiation

  9. Course in PF ratio

    Course in PaO2/FiO2 (PF) ratio (PaO2 divided by FiO2 provided)

    Measured: Until 30 days after ECMO initiation.

  10. Duration of mechanical ventilation.

    Duration of mechanical ventilation. Patients on mechanical ventilation via tracheostomy need to be 24 hours free of mechanical ventilation.

    Measured: Until 30 days after ECMO initiation.

  11. Left ventricular ejection fraction 30 days after ECMO initiation.

    Left ventricular ejection fraction 30 days after ECMO initiation.

    Measured: At 30 days after ECMO initiation.

  12. Time course in vasoactive inotropic score (VIS) during ECMO support

    Time course in vasoactive inotropic score (VIS) during ECMO support

    Measured: Until 30 days after ECMO initiation.

  13. Time course in NT-pro BNP during ECMO support.

    Time course in NT-pro BNP during ECMO support.

    Measured: Until 30 days after ECMO initiation.

  14. Quality of life at 1 year

    Quality of life on basis of EQ5D questionnaires

    Measured: 1 year after ECMO initiation

  15. Total health care costs

    Total healthcare costs in euros are determined by using the International Medical Consumption Questionnaire (iMCQ) and the calculated costs after 6 and 12 months of follow up

    Measured: 6 and 12 months after ECMO initiation

  16. Hospital readmission rate

    The number of hospital readmissions based on the information provided in the international Medical Consumption Questionnaire (iMCQ)

    Measured: 1 year

  17. Physiological substudy: Heart rate

    The average heart rate measured during 5 minutes

    Measured: 24 and 48 hours after ECMO initiation

  18. Physiological substudy: pulmonary artery catheter parameters

    pulmonary artery catheter parameters: pulmonary capillary wedge pressure, cardiac output, central venous pressure

    Measured: 24 and 48 hours after ECMO initiation

  19. Physiological substudy: Echocardiography

    Echocardiography: LV ejection fraction, TAPSE, VTI LVOT

    Measured: 24 and 48 hours after ECMO initiation

  20. Physiological substudy: microcirculation measurements

    Microcirculation measurements: Perfused vessel density (PVD [mm/mm2], Total vessel density (TVD [mm/mm2]

    Measured: 24 and 48 hours after ECMO initiation

  21. Physiological substudy: respiratory parameters

    Respiratory: FiO2, PEEP, Respiratory System Compliance (CRS) as the ratio between Vt/Dp.

    Measured: 24 and 48 hours after ECMO initiation

  22. Physiological substudy: delta NT-pro BNP

    delta NT-pro BNP

    Measured: 24 and 48 hours after ECMO initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start8 Jun 2023
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Adaptive Bayesian Platform Trial evaluating multiple interventions in multiple domains
Masking
None (open label)
Enrolment
430 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05913622
Sponsor's protocol ID
NL82979.078.23
Acronym
REMAP ECMO
Status last verified
Dec 2025
First submitted
12 Jun 2023
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cheng R, Hachamovitch R, Kittleson M, Patel J, Arabia F, Moriguchi J, Esmailian F, Azarbal B. Complications of extracorporeal membrane oxygenation for treatment of cardiogenic shock and cardiac arrest: a meta-analysis of 1,866 adult patients. Ann Thorac Surg. 2014 Feb;97(2):610-6. doi: 10.1016/j.athoracsur.2013.09.008. Epub 2013 Nov 8.

    PubMed 24210621

  • Keebler ME, Haddad EV, Choi CW, McGrane S, Zalawadiya S, Schlendorf KH, Brinkley DM, Danter MR, Wigger M, Menachem JN, Shah A, Lindenfeld J. Venoarterial Extracorporeal Membrane Oxygenation in Cardiogenic Shock. JACC Heart Fail. 2018 Jun;6(6):503-516. doi: 10.1016/j.jchf.2017.11.017. Epub 2018 Apr 11.

    PubMed 29655828

  • Schrage B, Becher PM, Bernhardt A, Bezerra H, Blankenberg S, Brunner S, Colson P, Cudemus Deseda G, Dabboura S, Eckner D, Eden M, Eitel I, Frank D, Frey N, Funamoto M, Gossling A, Graf T, Hagl C, Kirchhof P, Kupka D, Landmesser U, Lipinski J, Lopes M, Majunke N, Maniuc O, McGrath D, Mobius-Winkler S, Morrow DA, Mourad M, Noel C, Nordbeck P, Orban M, Pappalardo F, Patel SM, Pauschinger M, Pazzanese V, Reichenspurner H, Sandri M, Schulze PC, H G Schwinger R, Sinning JM, Aksoy A, Skurk C, Szczanowicz L, Thiele H, Tietz F, Varshney A, Wechsler L, Westermann D. Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation: Results From an International, Multicenter Cohort Study. Circulation. 2020 Dec;142(22):2095-2106. doi: 10.1161/CIRCULATIONAHA.120.048792. Epub 2020 Oct 9.

    PubMed 33032450

  • Thiele H, Zeymer U, Thelemann N, Neumann FJ, Hausleiter J, Abdel-Wahab M, Meyer-Saraei R, Fuernau G, Eitel I, Hambrecht R, Bohm M, Werdan K, Felix SB, Hennersdorf M, Schneider S, Ouarrak T, Desch S, de Waha-Thiele S; IABP-SHOCK II Trial (Intraaortic Balloon Pump in Cardiogenic Shock II) Investigators; IABP-SHOCK II Investigators. Intraaortic Balloon Pump in Cardiogenic Shock Complicating Acute Myocardial Infarction: Long-Term 6-Year Outcome of the Randomized IABP-SHOCK II Trial. Circulation. 2019 Jan 15;139(3):395-403. doi: 10.1161/CIRCULATIONAHA.118.038201. Epub 2018 Nov 11.

    PubMed 30586721

  • Grandin EW, Nunez JI, Willar B, Kennedy K, Rycus P, Tonna JE, Kapur NK, Shaefi S, Garan AR. Mechanical Left Ventricular Unloading in Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation. J Am Coll Cardiol. 2022 Apr 5;79(13):1239-1250. doi: 10.1016/j.jacc.2022.01.032.

    PubMed 35361346

  • Russo JJ, Aleksova N, Pitcher I, Couture E, Parlow S, Faraz M, Visintini S, Simard T, Di Santo P, Mathew R, So DY, Takeda K, Garan AR, Karmpaliotis D, Takayama H, Kirtane AJ, Hibbert B. Left Ventricular Unloading During Extracorporeal Membrane Oxygenation in Patients With Cardiogenic Shock. J Am Coll Cardiol. 2019 Feb 19;73(6):654-662. doi: 10.1016/j.jacc.2018.10.085.

    PubMed 30765031

  • Na SJ, Yang JH, Yang JH, Sung K, Choi JO, Hahn JY, Jeon ES, Cho YH. Left heart decompression at venoarterial extracorporeal membrane oxygenation initiation in cardiogenic shock: prophylactic versus therapeutic strategy. J Thorac Dis. 2019 Sep;11(9):3746-3756. doi: 10.21037/jtd.2019.09.35.

    PubMed 31656647

  • van Steenwijk MPJ, van Rosmalen J, Elzo Kraemer CV, Donker DW, Hermens JAJM, Kraaijeveld AO, Maas JJ, Akin S, Montenij LJ, Vlaar APJ, van den Bergh WM, Oude Lansink-Hartgring A, de Metz J, Voesten N, Boersma E, Scholten E, Beishuizen A, Lexis CPH, Peperstraete H, Schiettekatte S, Lorusso R, Gommers DAMPJ, Tibboel D, de Boer RA, Van Mieghem NMDA, Meuwese CL; REMAP ECMO LV unloading study group. A randomized embedded multifactorial adaptive platform for extra corporeal membrane oxygenation (REMAP ECMO) - design and rationale of the left ventricular unloading trial domain. Am Heart J. 2025 Jan;279:81-93. doi: 10.1016/j.ahj.2024.10.010. Epub 2024 Oct 22.

    PubMed 39447716

Questions about this trial

What is this clinical trial studying?

A study testing Intra-aortic balloon pump in people with Cardiogenic Shock, run by Erasmus Medical Center at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Myrthe van Steenwijk (+31650162551, m.p.j.vansteenwijk@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ECMO weaning success (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05913622, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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