AzTrials
AzTrials

Cardiogenic ShockNCT07351435

The Caribbean Registry of Extracorporeal Membrane Oxygenation (ECMO) From the University Hospital in Martinique

An observational study of Cardiogenic Shock and Malignant Arrhythmias, run by University of Genova.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing VV, VA or VAV ECMO implantation in the French West Indies and Guiana. All patients undergoing ECMO implantation will be prospectively registered. Read more about this study

Who is it for?
Ages Up to 90 years
How many people
1,200 participants
Where
No sites listed yet
Study dates
1 Feb 2026to 30 Jun 2033
How long will I take part?
1 Year
Phase
Observational
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 Up to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All consecutive patients implanted with a VV-ECMO, VA-ECMO or VAV-ECMO device by the UHM HeartTeam

Who may be able to join

  • All consecutive patients implanted with a veno-venous extracorporeal membrane oxygenation device or extracorporeal membrane oxygenation device by the HeartTeam from the University Hospital of Martinique (UHM) from January 2010

Who cannot join

  • Patients with incomplete data (primary endpoint and less than 80% secondary study outcomes)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Marc LICKER, MD contact

+41796234488

marc.licker@unige.ch

Jeremy MAZILE, BC perfusionnist contact

jermy.bazile@chu-martinique.fr

About this study

The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing VV, VA or VAV ECMO implantation in the French West Indies and Guiana. All patients undergoing ECMO implantation will be prospectively registered.

Read the detailed description

In the Caribbean region, access to advanced cardiac interventions faces difficulties owing to unequal distribution of health care resources, medical shortages and distance between health care centers in various islands.

At the University Hospital of Martinique (UHM) in Fort de France, a mobile ECMO team is available 24h a day, 7 days a week, for cardiopulmonary mechanical support in the French Overseas Territories and neighboring islands.

Implantation of veno-venous or veno-arterial (VV or VA) ECMO can be performed at the UHM or at remote hospitals. Some patients on VA-ECMO are transfered by airflight to the UHM and/or to French mainland whenever cardiac transplantation is indicated.

Since 2010, the ECMO-UHM database is a prospective event-driven registry housed and updated by the HeartTeam (perfusionnists, emergency and ICU physicians, cardiac surgeons, cardiothoracic anesthesiologists, cardiologists).

Keywords
acute heart failure, respiratory insufficiency
Medical subject headings
Shock, Cardiogenic, Ischemia, Sickle Cell Trait, Pulmonary Embolism, Sepsis, Acute Lung Injury, Heart Arrest, Respiratory Insufficiency

What participants receive

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

Study groups in NCT07351435
Study groupRoleWhat they receive
VV-ECMOPatients with respiratory failure
VA-ECMOPatients with cardiac failure or combined cardiopulmonary failure
VAV-ECMOPatients initially on VV or VA-ECMO who require additional respiratory/circulatory support

What is being measured

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

  1. Mortality at 30 days

    Number of deceased participants as assessed at 30 days after ECMO implantation

    Measured: from canula implantation to 30 days afterwards

Secondary outcomes (1)

  1. Number of participants with major adverse events

    Major Adverse events (AE; numbers and rates) as assessed by the consensus statement of the mechanical circulatory support academic research consortium

    Measured: From canula implantation to up to 6 months after ECMO implantation

Timeline

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

  1. First posted20 Jan 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion31 Dec 2032 (estimated)
  4. Study completion30 Jun 2033 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,200 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07351435
Sponsor's protocol ID
18-11-2025 CHUM CVT
Status last verified
Jan 2025
First submitted
18 Nov 2025
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: only IPD used in the results publication

Publications

  • Serpa Neto A, Higgins AM, Bailey MJ, Anderson S, Bernard S, Fulcher BJ, Jones A, Linke NJ, Board JV, Brodie D, Buhr H, Burrell AJC, Cooper DJ, Fan E, Fraser JF, Gattas DJ, Hopper IK, Huckson S, Litton E, McGuinness SP, Nair P, Orford N, Parke RL, Pellegrino VA, Pilcher DV, Dicker C, Reddi BAJ, Stub D, Trapani TV, Udy AA, Hodgson CL; EXCEL Study Investigators on behalf of the International ECMO Network (ECMONet). Long-Term Functional Outcomes in the First 12 Months After VA-ECMO in Adult Patients: A Prospective, Multicenter Study. Circ Heart Fail. 2025 Jun;18(6):e012476. doi: 10.1161/CIRCHEARTFAILURE.124.012476. Epub 2025 Apr 29.

    PubMed 40298907

  • Ling RR, Chen Y, Low CJW, Agerstrand C, Jung JS, Lim SL, Lorusso R, Mueller T, Okada Y, Tonna JE, Shekar K, Brodie D, MacLaren G, Ramanathan K. Left ventricular unloading during extracorporeal cardiopulmonary resuscitation: a target trial emulation of the ELSO registry. Crit Care. 2025 May 8;29(1):186. doi: 10.1186/s13054-025-05345-3.

    PubMed 40340843

  • Grazioli A, Plazak M, Willsey K, Rabin J, Rector RP, Belyayev L, Lankford AS, Scalea TM, Shah A, Taylor BS, Gladwin MT. Outcomes and survival prediction in adults with sickle cell disease treated with extracorporeal membrane oxygenation. Blood Adv. 2025 Oct 14;9(19):4881-4890. doi: 10.1182/bloodadvances.2025016368.

    PubMed 40644625

  • Labrada L, Alarfaj M, Tran L, Granger H, Hernandez A, Hu J, Baker J, Grandin EW, Delgado AA, Katz JN, Miller PE, Alviar CL, Osborn E, Bacchetta MD, Lindenfeld J, Shah Z, Rali AS. Optimal ECLS Support in Mixed Cardiogenic and Septic Shock: An ELSO Registry Analysis. JACC Adv. 2025 Oct;4(10 Pt 1):101965. doi: 10.1016/j.jacadv.2025.101965. Epub 2025 Jul 23.

    PubMed 40704940

  • Wang L, Wang K, Wang Y, Yang F, Li C, Hao X, Du Z, Rycus PT, Tonna JE, Fan E, Wang H, Hou X. A simple VA-ECMO bundle in adult patients with cardiogenic shock: an analysis of ELSO registry. EClinicalMedicine. 2025 Aug 7;87:103423. doi: 10.1016/j.eclinm.2025.103423. eCollection 2025 Sep.

    PubMed 40823501

  • Baldetti L, Pontillo D, Capoccia M, Kowalewski M, Tonna JE, Broman M, Conrad SA, Swol J, Scandroglio AM, Brewer JM, Maybauer MO, Lorusso R. Venopulmonary extracorporeal life support: An Extracorporeal Life Support Organization registry analysis. J Heart Lung Transplant. 2026 Apr;45(4):621-633. doi: 10.1016/j.healun.2025.12.024. Epub 2026 Jan 6.

    PubMed 41506589

  • Moynihan KM, Sharma M, Mehta A, Lillie J, Ziegenfuss M, Festa M, Chan T, Thiagarajan R. Race-Conscious Research Using Extracorporeal Life Support Organization Registry Data: A Narrative Review. ASAIO J. 2024 Sep 1;70(9):721-733. doi: 10.1097/MAT.0000000000002206. Epub 2024 Apr 18.

    PubMed 38648078

  • Remy T, Jegard J, Chenouard A, Maminirina P, Liet JM, Couec ML, Joram N, Bourgoin P. Characteristics and outcomes of children and young adults with sickle cell disease supported with extracorporeal membrane oxygenation (ECMO): An updated analysis of the ELSO registry. Artif Organs. 2025 Mar;49(3):508-515. doi: 10.1111/aor.14880. Epub 2024 Oct 3.

    PubMed 39360897

  • Mazzeffi M, Zaaqoq A, Curley J, Buchner J, Wu I, Beller J, Teman N, Glance L. Survival After Extracorporeal Cardiopulmonary Resuscitation Based on In-Hospital Cardiac Arrest and Cannulation Location: An Analysis of the Extracorporeal Life Support Organization Registry. Crit Care Med. 2024 Dec 1;52(12):1906-1917. doi: 10.1097/CCM.0000000000006439. Epub 2024 Oct 9.

    PubMed 39382377

  • Kanwar MK, Shah P, Cascino T, Grinstein J, Goldstein D, Hernandez-Montfort J, Li S, Uriel N, Molina E, Cantor R, Komanduri B, Pagani FD, Kirklin JK. Impact of Preoperative Temporary Mechanical Circulatory Support on Durable LVAD Outcomes: An Analysis of The Society of Thoracic Surgeons National Intermacs Database. JACC Heart Fail. 2025 Nov;13(11):102671. doi: 10.1016/j.jchf.2025.102671. Epub 2025 Oct 8.

    PubMed 41193107

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiogenic Shock and Malignant Arrhythmias, run by University of Genova.

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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Marc LICKER, MD (+41796234488, marc.licker@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality at 30 days (time frame: from canula implantation to 30 days afterwards). 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 NCT07351435, which also lists 10 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 20 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in