Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by ECMO-VA for Refractory Cardiogenic Shock
CAVA-ECMO
1 other identifier
observational
600
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2023
CompletedFirst Posted
Study publicly available on registry
March 28, 2023
CompletedStudy Start
First participant enrolled
April 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 28, 2028
April 17, 2026
April 1, 2026
5 years
March 6, 2023
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of atrial fibrillation in patients assisted by veno-arterial ECMO.
Atrial fibrillation will be defined as an episode of AF ≥ 30 minutes or requiring pharmacological or electrical cardioversion.
day 30
Secondary Outcomes (8)
Number of ventricular rhythm disorders
day 30
duration of VA ECMO support
day 30
duration of ICU stay
day 30
duration of mechanical ventilation
day 30
Number of living patient
day 28, day 360
- +3 more secondary outcomes
Study Arms (1)
Patients with refractory cardiogenic shock assisted with ECMO VA
Interventions
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)
Eligibility Criteria
Major Patients Assisted by VA ECMO in Intensive care
You may qualify if:
- Patient 18 years of age or older
- Assistance with VA ECMO
You may not qualify if:
- Opposition to the use of data.
- Persons under legal protection (curators, guardianship), judicially safeguarded.
- VA ECMO for refractory cardiac arrest.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
CHU Angers
Angers, 49100, France
Hospices Civils de Lyon - Hôpital Louis Pradel
Bron, 69500, France
CHU Caen Normandie - Hôpital Côte de Nacre
Caen, 14000, France
CHRU Tours - Hôpital Trousseau
Chambray-lès-Tours, 37170, France
CHU Dijon Bourgogne - Hôpital François Mitterrand
Dijon, 21000, France
CHU Grenoble Alpes - Site Nord
Grenoble, 38700, France
CHU Lille - Institut Cœur Poumon
Lille, 59000, France
CHU Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34295, France
CHU Nantes - Hôpital Nord Laennec
Nantes, 44000, France
Pitié Salpêtrière Hospital, Intensive Care Unit - Resuscitation
Paris, 75013, France
Pitié-Salpêtrière Hospital, Cardiovascular Surgery Intensive Care Unit
Paris, 75013, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Hôpital Bichat
Paris, 75018, France
Hôpital Bichat
Paris, 75018, France
CHU Bordeaux - Hôpital cardiologique, GH Sud Pessac
Pessac, 33600, France
CHU Rennes, Hôpital Pontchaillou
Rennes, 35000, France
Hôpitaux universitaires de Strasbourg - Hôpital Civil
Strasbourg, 67000, France
CHU Toulouse - Hôpital de Rangueil
Toulouse, 31300, France
CHU Toulouse - Hôpital de Rangueil
Toulouse, 31300, France
CHRU Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2023
First Posted
March 28, 2023
Study Start
April 28, 2023
Primary Completion (Estimated)
April 28, 2028
Study Completion (Estimated)
April 28, 2028
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- 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
- Access Criteria
- Researchers who provide a methodologically sound proposal
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.