Post Intensive Care Unit Atrial Fibrillation

Not Applicable

Recruiting

• Conditions: Critical Illness; Atrial Fibrillation
• Interventions: Device: Implantable ECG holter device (Biomonitor3, Biotronik)

• Registration Number: NCT05860894
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Study Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-16
• Study Start: 2023-09-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implantable ECG holter device	Implantable ECG holter device (Biomonitor3, Biotronik)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Besancon; 🇫🇷 Besancon, France