Post Intensive Care Unit Atrial Fibrillation (PIAF)

Centre Hospitalier Universitaire de Besancon

Status: Enrolling

Conditions: Atrial Fibrillation; Critical Illness

Treatments: Device: Implantable ECG holter device (Biomonitor3, Biotronik)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05860894

2022-A01292-41

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Implantable ECG holter device

Experimental group

Description:

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.

Treatment:

Device: Implantable ECG holter device (Biomonitor3, Biotronik)