Post Intensive Care Unit Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-19

Study Completion Date

2026-12-31

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.

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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.

Conditions

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Atrial Fibrillation Critical Illness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Implantable ECG holter device

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.

Group Type EXPERIMENTAL

Implantable ECG holter device (Biomonitor3, Biotronik)

Intervention Type DEVICE

Subcutaneous implantation of ECG holder device to monitor ECG

Interventions

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Implantable ECG holter device (Biomonitor3, Biotronik)

Subcutaneous implantation of ECG holder device to monitor ECG

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No