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NCT Number: NCT05860894

Post Intensive Care Unit Atrial Fibrillation

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Besancon

Besançon, 25000, France

Location status: Recruiting

Location contact

Charles Monnin, MD

CONTACT

[email protected]

Marc Badoz, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable ECG holter device (Biomonitor3, Biotronik)

Device

Subcutaneous implantation of ECG holder device to monitor ECG

Primary outcomes

  1. Rate of recurrence of atrial fibrillation

    Time frame: 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 outcomes

  1. Burden of atrial fibrillation in absolute value

    Time frame: up to 2 years after ICU discharge

    Burden of atrial fibrillation assessed as time (in days, hours and minutes), expressed as a absolute value

  2. Burden of atrial fibrillation (percentage of time spent in atrial fibrillation)

    Time frame: 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

  3. Rate of Stroke

    Time frame: up to 2 years after ICU discharge

    Ischemic or hemorrhagei stroke documented by imaging, major bleeding (ISTH classification) or documented peripheral emboli

  4. Number of participants with Change in treatment

    Time frame: up to 2 years after ICU discharge

    Changes in treatment due to the discovery of atrial fibrillation

Study contacts

Contact information is provided by the study sponsor or research team.

Charles Monnin, MD

CONTACT

[email protected]

33381668186

Elise Robert

CONTACT

[email protected]

33381219086

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Biotronik SE & Co. KG

Registry information

Acronym: PIAF

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 16, 2023
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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