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Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by ECMO-VA for Refractory Cardiogenic Shock

Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by Extra Corporeal Membrane Oxygenation Veno-arterial (ECMO VA) for Refractory Cardiogenic Shock

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05788120
Acronym
CAVA-ECMO
Enrollment
600
Registered
2023-03-28
Start date
2023-04-28
Completion date
2028-04-28
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Rhythm Disorder

Keywords

Arrhythmia, Veno-arterial Extra Corporeal Membrane, Oxygenation (VA ECMO), Cardiogenic shock.

Brief summary

Brief Summary : Rhythm disorders are a frequent and potentially serious complication of critical patients in the ICU and postoperative cardiac surgery. In particular, atrial fibrillation (AF) is the most common rhythm disorder in patients admitted to the ICU and is associated with excess mortality during acute circulatory failure. In postoperative cardiac surgery, AF affects 15 to 45% of patients. In addition to hemodynamic effects, AF increases the risk of stroke, bleeding, respiratory or renal failure, and doubles mortality at 30 days and 6 months. In the longer term, the recurrence rate of AF within 1 year after hospital discharge is about 50%. Similarly, other rhythm disorders, supraventricular or ventricular, can be life-threatening in ICU patients. While the incidence and complications of rhythm disorders are well documented during sepsis, cardiogenic shock or after cardiac surgery, there are to our knowledge no data on the frequency and complications of rhythm disorders in patients assisted by VA ECMO. The primary objective is to describe the incidence of supraventricular rhythm disorders in patients assisted by VA ECMO.

Detailed description

This study is an observational study to describe the conditions of occurrence of arrhythmias, particularly atrial fibrillation, in patients supported by VA ECMO, as well as their short-term and long-term prognosis. Patients will be recruited from the intensive care units and CRFs will be completed by the investigators at each of the participating centers. Data will be collected directly from the medical records, except for vital status at 1 year, which may be collected by telephone from the patient by the investigator at the center in the absence of data in the medical record. Atrial fibrillation episodes will be recorded on a 12-lead electrocardiogram and securely transmitted to the coordinating center. In addition, investigators will send weekly data to the principal investigator for incidence calculation. Patients or their relatives will be informed about the study by an information sheet presented and explained by the investigator or another person authorized to conduct the research. The investigator will record the patient's consent in the patient's medical record.

Interventions

OTHERFollow up by phone call

Centralized review of ECGs by the Pitié-Salpêtrière rhythmology department and collection of vital status at 12 months (if information not available, telephone call to the patient)

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient 18 years of age or older * Assistance with VA ECMO

Exclusion criteria

* Opposition to the use of data. * Persons under legal protection (curators, guardianship), judicially safeguarded. * VA ECMO for refractory cardiac arrest.

Design outcomes

Primary

MeasureTime frameDescription
Number of atrial fibrillation in patients assisted by veno-arterial ECMO.day 30Atrial fibrillation will be defined as an episode of AF ≥ 30 minutes or requiring pharmacological or electrical cardioversion.

Secondary

MeasureTime frameDescription
Number of ventricular rhythm disordersday 30ventricular tachycardia, ventricular fibrillation
duration of VA ECMO supportday 30duration of VA ECMO support
duration of ICU stayday 30duration of ICU stay
duration of mechanical ventilationday 30duration of mechanical ventilation
Number of living patientday 28, day 360Number of living patient
Number of thrombo-embolic complicationsday 30acute limb ischemia, circuit thrombosis, membrane thrombosis
Number of neurological complicationsday 30ischemic and hemorrhagic stroke
Number of bleeding complicationsday 30bleeding requiring transfusion of packed red blood cells (\> 3 units / 24h) or requiring surgical intervention or interventional procedure (digestive or implantation site bleeding, need for revision surgery

Countries

France

Contacts

CONTACTAdrien Bougle, PhD
Adrien.bougle@aphp.fr+33 1 42 16 29 91

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026