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Clinical Trials in France / NCT05860894
Recruiting Not applicable

Post Intensive Care Unit Atrial Fibrillation

NCT05860894 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire de Besancon
Phase
Not applicable
Started
2023-09-19
Last updated
2024-02-01

Condition(s) studied

Atrial FibrillationCritical Illness

Investigational drug(s) / intervention(s)

Implantable ECG holter device (Biomonitor3, Biotronik)

Implantable ECG holter device (Biomonitor3, Biotronik): Subcutaneous implantation of ECG holder device to monitor ECG

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier Universitaire de Besancon Besançon France Recruiting

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Other trials for the same condition

Interest of a Hybrid Connected Watch for Cardiac Rhythm Monitoring in Post-operative Cardiac Surgery Recruiting
STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation Active, not recruiting
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A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05860894 on ClinicalTrials.gov ↗ ← All trials in France