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

April 16, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49100
      • Bron, France, 69500
        • Recruiting
        • Hospices Civils de Lyon - Hopital Louis Pradel
        • Contact:
      • Caen, France, 14000
        • Recruiting
        • CHU Caen Normandie - Hôpital Côte de Nacre
        • Contact:
      • Chambray-lès-Tours, France, 37170
        • Not yet recruiting
        • CHRU Tours - Hopital Trousseau
        • Contact:
      • Dijon, France, 21000
      • Grenoble, France, 38700
      • Lille, France, 59000
        • Not yet recruiting
        • CHU Lille - Institut Coeur Poumon
        • Contact:
      • Montpellier, France, 34295
      • Nantes, France, 44000
        • Recruiting
        • CHU Nantes - Hopital Nord Laënnec
        • Contact:
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou
        • Contact:
      • Paris, France, 75018
      • Paris, France, 75013
        • Recruiting
        • Pitié Salpêtrière Hospital, Intensive Care Unit - Resuscitation
        • Contact:
      • Paris, France, 75013
        • Recruiting
        • Pitié-Salpêtrière Hospital, Cardiovascular Surgery Intensive Care Unit
        • Contact:
      • Pessac, France, 33600
        • Not yet recruiting
        • CHU Bordeaux - Hôpital cardiologique, GH Sud Pessac
        • Contact:
      • Rennes, France, 35000
      • Strasbourg, France, 67000
        • Completed
        • Hôpitaux Universitaires de Strasbourg - Hôpital Civil
      • Toulouse, France, 31300
        • Recruiting
        • CHU Toulouse - Hopital de Rangueil
        • Contact:
      • Vandœuvre-lès-Nancy, France, 54500
        • Recruiting
        • Chru Nancy - Hopitaux de Brabois
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Major Patients Assisted by VA ECMO in Intensive care

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with refractory cardiogenic shock assisted with ECMO VA
Other: Follow 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of atrial fibrillation in patients assisted by veno-arterial ECMO.
Time Frame: day 30
Atrial fibrillation will be defined as an episode of AF ≥ 30 minutes or requiring pharmacological or electrical cardioversion.
day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of ventricular rhythm disorders
Time Frame: day 30
ventricular tachycardia, ventricular fibrillation
day 30
duration of VA ECMO support
Time Frame: day 30
duration of VA ECMO support
day 30
duration of ICU stay
Time Frame: day 30
duration of ICU stay
day 30
duration of mechanical ventilation
Time Frame: day 30
duration of mechanical ventilation
day 30
Number of living patient
Time Frame: day 28, day 360
Number of living patient
day 28, day 360
Number of thrombo-embolic complications
Time Frame: day 30
acute limb ischemia, circuit thrombosis, membrane thrombosis
day 30
Number of neurological complications
Time Frame: day 30
ischemic and hemorrhagic stroke
day 30
Number of bleeding complications
Time Frame: day 30
bleeding 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
day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2023

Primary Completion (Estimated)

April 28, 2028

Study Completion (Estimated)

April 28, 2028

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP221056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

IPD Sharing Time Frame

Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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