Post Intensive Care Unit Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— PIAF  

Official title:

Post Intensive Care Unit Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860894
• Other study ID #: 2022-A01292-41
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Charles Monnin, MD
• Phone: 33381668186
• Email: charles.monnin[@]edu.univ-fcomte.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Critical Illness

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besancon	Besancon

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Biotronik SE & Co. KG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recurrence of atrial fibrillation	Any episode of atrial fibrillation, atrial tachycardia or atrial flutter lasting at least 1 minute, as documented on the implantable device recordings	up to 1 year after ICU discharge
Secondary	Burden of atrial fibrillation in absolute value	Burden of atrial fibrillation assessed as time (in days, hours and minutes), expressed as a absolute value	up to 2 years after ICU discharge
Secondary	Burden of atrial fibrillation (percentage of time spent in atrial fibrillation)	Burden of atrial fibrillation assessed as time (in days, hours and minutes) expressed as a percentage time spent in atrial fibrillation	up to 2 years after ICU discharge
Secondary	Rate of Stroke	Ischemic or hemorrhagei stroke documented by imaging, major bleeding (ISTH classification) or documented peripheral emboli	up to 2 years after ICU discharge
Secondary	Number of participants with Change in treatment	Changes in treatment due to the discovery of atrial fibrillation	up to 2 years after ICU discharge