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| Name | Class |
|---|---|
| Biotronik SE & Co. KG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantable ECG holter device | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable ECG holter device (Biomonitor3, Biotronik) | Device | Subcutaneous implantation of ECG holder device to monitor ECG |
|
| 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 |
| 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) |
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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:
Written informed consent
Patient affiliated to a social security regime (or beneficiary thereof)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charles Monnin, MD | Contact | 33381668186 | charles.monnin@edu.univ-fcomte.fr | |
| Elise Robert | Contact | 33381219086 | e1robert@chu-besancon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Besancon | Recruiting | Besançon | 25000 | France |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |