Post Intensive Care Unit Atrial Fibrillation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Post Intensive Care Unit Atrial Fibrillation

Conditions
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Atrial Fibrillation, Critical Illness

Intervention / Treatment
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* Device: Implantable ECG holter device (Biomonitor3, Biotronik)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implantable ECG holter device<br>Adult patients with new onset atrial fibrillation occuring in the ICU will be implanted with an implantable ECG holter device (Biomonitor3, Biotronik) to monitor arrhythmia episodes up to 2 years after ICU discharge. | Device: Implantable ECG holter device (Biomonitor3, Biotronik)<br>* Subcutaneous implantation of ECG holder device to monitor ECG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrence of atrial fibrillation | Any episode of atrial fibrillation, atrial tachycardia or atrial flutter lasting at least 1 minute, as documented on the implantable device recordings | up to 1 year after ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burden of atrial fibrillation in absolute value | Burden of atrial fibrillation assessed as time (in days, hours and minutes), expressed as a absolute value | up to 2 years after ICU discharge | 
| Burden of atrial fibrillation (percentage of time spent in atrial fibrillation) | Burden of atrial fibrillation assessed as time (in days, hours and minutes) expressed as a percentage time spent in atrial fibrillation | up to 2 years after ICU discharge | 
| Rate of Stroke | Ischemic or hemorrhagei stroke documented by imaging, major bleeding (ISTH classification) or documented peripheral emboli | up to 2 years after ICU discharge | 
| Number of participants with Change in treatment | Changes in treatment due to the discovery of atrial fibrillation | up to 2 years after ICU discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intensive care unit, atrial fibrillation