Atrial Fibrillation, Critical Illness
Conditions
Keywords
intensive care unit, atrial fibrillation
Brief summary
Atrial fibrillation (AF) is a common heart rhythm disorder in the intensive care unit (ICU). It can be precipitated by multiple factors but it is unclear whether AF persists after discharge from the ICU, and long term. This study will investigate whether AF recurs up to one year after ICU discharge.
Detailed description
Atrial fibrillation (AF) is the most common heart rhythm disorder encountered in the intensive care unit (ICU). It can be precipitated by multiple factors present in critically ill patients, such as tissue hypoxia, metabolic disorders etc. There is a paucity of data regarding the persistence of AF in these patients after discharge from the ICU, and in the longer term. Therefore, this study will investigate whether AF recurs up to one year after ICU discharge using an implantable ECG Holter device in adult patients discharged alive from the ICU, with documented new onset AF.
Interventions
DEVICEImplantable ECG holter device (Biomonitor3, Biotronik)
Subcutaneous implantation of ECG holder device to monitor ECG
Sponsors
Biotronik SE & Co. KG
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * New onset atrial fibrillation diagnosed in the ICU (12 lead ECG or documented episode of atrial fibrillation lasting at least 30 seconds) * Patient hospitalized in the ICU with at least one of the following two criteria: * orotracheal intubation for mechanical ventilation * AND/OR treatment with amines (vasopressors or inotropic agents) * Written informed consent * Patient affiliated to a social security regime (or beneficiary thereof)
Exclusion criteria
* Documented history of atrial fibrillation * patients admitted to the ICU after cardiothoracic surgery * Patients with life expectancy \<12 months * Patients under legal or judicial protection * Patients with no social security coverage * Patients within the exclusion period of another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of recurrence of atrial fibrillation | up to 1 year after ICU discharge | Any episode of atrial fibrillation, atrial tachycardia or atrial flutter lasting at least 1 minute, as documented on the implantable device recordings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Burden of atrial fibrillation in absolute value | up to 2 years after ICU discharge | Burden of atrial fibrillation assessed as time (in days, hours and minutes), expressed as a absolute value |
| Burden of atrial fibrillation (percentage of time spent in atrial fibrillation) | up to 2 years after ICU discharge | Burden of atrial fibrillation assessed as time (in days, hours and minutes) expressed as a percentage time spent in atrial fibrillation |
| Rate of Stroke | up to 2 years after ICU discharge | Ischemic or hemorrhagei stroke documented by imaging, major bleeding (ISTH classification) or documented peripheral emboli |
| Number of participants with Change in treatment | up to 2 years after ICU discharge | Changes in treatment due to the discovery of atrial fibrillation |
Countries
France
Contacts
Primary ContactCharles Monnin, MD
Backup ContactElise Robert
Outcome results
None listed