An observational study in Cardiogenic Shock, Malignant Arrhythmias and Ischemic or Valvular Heart Failure, sponsored by University of Genova. Not yet recruiting. Open to participants aged Up to 90 Years. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by University of Genova · Observational
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.
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).
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 200 across 155 observational studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →University of Genova is the lead sponsor of 34 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patients implanted with a VV-ECMO, VA-ECMO or VAV-ECMO device by the UHM HeartTeam
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with respiratory failure
Patients with cardiac failure or combined cardiopulmonary failure
Patients initially on VV or VA-ECMO who require additional respiratory/circulatory support
Mortality at 30 days
Number of deceased participants as assessed at 30 days after ECMO implantation
Time frame: from canula implantation to 30 days afterwards
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
Time frame: From canula implantation to up to 6 months after ECMO implantation
No study locations are listed for this record.
Plan to share: Yes — only IPD used in the results publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: from January 2026 to December 2032
Start is estimated for Feb 2026; primary completion for Dec 2032, 82 months later.
Of 79 non-industry observational studies under Shock, Cardiogenic, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 19. This study's planned 82 months is above that.
Counting every sponsor, half of 84 studies reached it within 45 months; a quarter within 24.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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University of Genova