PIAF: Post Intensive Care Unit Atrial Fibrillation

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05860894

Collaborator

Biotronik SE & Co. KG (Industry)

150

Enrollment

Location

Arm

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Critical Illness	Device: Implantable ECG holter device (Biomonitor3, Biotronik)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Post Intensive Care Unit Atrial Fibrillation

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Burden of atrial fibrillation in absolute value [up to 2 years after ICU discharge]
Burden of atrial fibrillation assessed as time (in days, hours and minutes), expressed as a absolute value
Burden of atrial fibrillation (percentage of time spent in atrial fibrillation) [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
Rate of Stroke [up to 2 years after ICU discharge]
Ischemic or hemorrhagei stroke documented by imaging, major bleeding (ISTH classification) or documented peripheral emboli
Number of participants with Change in treatment [up to 2 years after ICU discharge]
Changes in treatment due to the discovery of atrial fibrillation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Besancon	Besancon		France	25000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon
Biotronik SE & Co. KG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT05860894

Other Study ID Numbers:

2022-A01292-41

First Posted:

May 16, 2023

Last Update Posted:

May 19, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Besancon

intensive care unit

atrial fibrillation

Additional relevant MeSH terms:

Atrial Fibrillation

Critical Illness

Study Results

No Results Posted as of May 19, 2023