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

NCT05913622 | Recruiting DMC

• 1 other identifier: NL82979.078.23
• Study Type: interventional
• Target: 430
• Locations: 2 countries
• Sites: 14

Brief 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.

Conditions

Cardiogenic Shock

Keywords

Left ventricular unloading; Venoarterial ExtraCorporeal Membrane Oxygenation (VA ECMO); Cardiogenic shock

Outcome Measures

Primary Outcomes (2)

• 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).

  30 days

• Physiological substudy: End diastolic volume

  End diastolic volume as assessed by echocardiography

  within 24 hours after ECMO initiation

Secondary Outcomes (22)

• Treatment failure

  During ECMO support

• 30 day, 90 day and 1 year mortality

  30 days, 90 days and 1 year after ECMO initiation

• ECMO support duration

  Until 30 days after ECMO initiation

• Major bleeding events

  Until 30 days after ECMO initiation

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

  Until 30 days after ECMO initiation

Study Arms (2)

IABP unloading arm

EXPERIMENTAL

This 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.

Device: Intra-aortic balloon pump

ECMO alone arm

NO INTERVENTION

This group of patients will receive VA ECMO support without left ventricular unloading device after randomization.

Interventions

Intra-aortic balloon pump DEVICE

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

Also known as: IABP

IABP unloading arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Initiation of LV unloading (IABP or Impella) possible ≤ 8 hours after ECMO initiation

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Dutch Heart Foundation: collaborator

Study Sites (14)

AZ Sint-Jan Brugge

Bruges, Belgium

RECRUITING

ZOL Genk

Genk, Belgium

RECRUITING

UZ Gent

Ghent, Belgium

RECRUITING

Amphia hospital

Breda, North Brabant, 4818 CK, Netherlands

NOT YET RECRUITING

Catharina hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

NOT YET RECRUITING

Amsterdam University Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

NOT YET RECRUITING

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

NOT YET RECRUITING

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Haga ziekenhuis

The Hague, South Holland, 2545 AA, Netherlands

NOT YET RECRUITING

Antonius hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

NOT YET RECRUITING

University Medical Center Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

NOT YET RECRUITING

OLVG

Amsterdam, Netherlands

RECRUITING

Maastricht UMC

Maastricht, Netherlands

RECRUITING

Radboud UMC

Nijmegen, Netherlands

RECRUITING

Related Publications (8)

• 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.

  PMID: 24210621 BACKGROUND

• 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.

  PMID: 29655828 BACKGROUND

• 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.

  PMID: 33032450 BACKGROUND

• 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.

  PMID: 30586721 BACKGROUND

• 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.

  PMID: 35361346 BACKGROUND

• 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.

  PMID: 30765031 BACKGROUND

• 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.

  PMID: 31656647 BACKGROUND

• 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.

  PMID: 39447716 DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Intra-Aortic Balloon Pumping

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Counterpulsation; Assisted Circulation; Surgical Procedures, Operative

Study Officials

• Christiaan Meuwese

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Myrthe van Steenwijk

CONTACT

+31650162551; m.p.j.vansteenwijk@erasmusmc.nl

Christiaan Meuwese

CONTACT

+31631135752; c.meuwese@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is possible as the device is visible after placement.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Adaptive Bayesian Platform Trial evaluating multiple interventions in multiple domains

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: June 8, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

BE (3); NL (11)