NCT07351435

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
87mo left

Started Feb 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Feb 2026Jun 2033

First Submitted

Initial submission to the registry

November 18, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2032

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2033

Last Updated

January 20, 2026

Status Verified

January 1, 2025

Enrollment Period

6.9 years

First QC Date

November 18, 2025

Last Update Submit

January 9, 2026

Conditions

Keywords

acute heart failurerespiratory insufficiency

Outcome Measures

Primary Outcomes (1)

  • Mortality at 30 days

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

    from canula implantation to 30 days afterwards

Secondary Outcomes (1)

  • Number of participants with major adverse events

    From canula implantation to up to 6 months after ECMO implantation

Study Arms (3)

VV-ECMO

Patients with respiratory failure

VA-ECMO

Patients with cardiac failure or combined cardiopulmonary failure

VAV-ECMO

Patients initially on VV or VA-ECMO who require additional respiratory/circulatory support

Eligibility Criteria

AgeUp to 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 40298907BACKGROUND
  • 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.

    PMID: 40340843BACKGROUND
  • 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.

    PMID: 40644625BACKGROUND
  • 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.

    PMID: 40704940BACKGROUND
  • 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.

    PMID: 40823501BACKGROUND
  • 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 Jan 6:S1053-2498(25)02480-5. doi: 10.1016/j.healun.2025.12.024. Online ahead of print.

    PMID: 41506589BACKGROUND
  • 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.

    PMID: 38648078BACKGROUND
  • 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.

    PMID: 39360897BACKGROUND
  • 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.

    PMID: 39382377BACKGROUND
  • 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.

    PMID: 41193107BACKGROUND

MeSH Terms

Conditions

Shock, CardiogenicIschemiaSickle Cell TraitPulmonary EmbolismSepsisAcute Lung InjuryHeart ArrestRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShockAnemia, Sickle CellAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisInfectionsSystemic Inflammatory Response SyndromeInflammationLung InjuryRespiration Disorders

Study Officials

  • Marc LICKER, BC

    CHU Martinique

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc LICKER, MD

CONTACT

Jeremy MAZILE, BC perfusionnist

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Professor at the University of Geneva, Consultant in the department of Cardiothoracic Anesthesia and Critical Care at the University Hospital of Martinique

Study Record Dates

First Submitted

November 18, 2025

First Posted

January 20, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

June 30, 2033

Last Updated

January 20, 2026

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

only IPD used in the results publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
from January 2026 to December 2032