Post Intensive Care Unit Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implantable ECG holter device (Biomonitor3, Biotronik).
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Critical Illness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Implantable ECG holter device (Biomonitor3, Biotronik)
Subcutaneous implantation of ECG holder device to monitor ECG
Primary outcome measures
- Rate of recurrence of atrial fibrillation [Time frame: up to 1 year after ICU discharge]
Secondary outcome measures (4)
- Burden of atrial fibrillation in absolute value [Time frame: up to 2 years after ICU discharge]
- Burden of atrial fibrillation (percentage of time spent in atrial fibrillation) [Time frame: up to 2 years after ICU discharge]
- Rate of Stroke [Time frame: up to 2 years after ICU discharge]
- Number of participants with Change in treatment [Time frame: up to 2 years after ICU discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Centre Hospitalier Universitaire de Besancon — Besançon
Identifiers
NCT: NCT05860894 · 2022-A01292-41