Post Intensive Care Unit Atrial Fibrillation (PIAF)

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Atrial Fibrillation
• Intervention / Treatment: Device: Implantable ECG holter device (Biomonitor3, Biotronik)

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charles Monnin, MD; Phone Number: 33381668186; Email: charles.monnin@edu.univ-fcomte.fr
• Study Contact Backup: Name: Elise Robert; Phone Number: 33381219086; Email: e1robert@chu-besancon.fr

Study Locations

• France
  • Besancon, France, 25000
    • Recruiting
    • Centre Hospitalier Universitaire de Besançon
    • Contact: Charles Monnin, MD; Email: charles.monnin@edu.univ-fcomte.fr
    • Contact: Marc Badoz, MD; Email: mbadoz@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Implantable ECG holter device (Biomonitor3, Biotronik); Subcutaneous implantation of ECG holder device to monitor ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Number of participants with Change in treatment	Changes in treatment due to the discovery of atrial fibrillation	up to 2 years after ICU discharge

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: Biotronik SE & Co. KG

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: intensive care unit; atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Critical Illness
• Other Study ID Numbers: 2022-A01292-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No