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Post Intensive Care Unit Atrial Fibrillation (PIAF)

Primary Purpose

Atrial Fibrillation, Critical Illness

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Implantable ECG holter device (Biomonitor3, Biotronik)
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring intensive care unit, atrial fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Hospitalier Universitaire de Besancon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implantable ECG holter device

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2023
Last Updated
May 17, 2023
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Biotronik SE & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT05860894
Brief Title
Post Intensive Care Unit Atrial Fibrillation
Acronym
PIAF
Official Title
Post Intensive Care Unit Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Biotronik SE & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Critical Illness
Keywords
intensive care unit, atrial fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implantable ECG holter device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Implantable ECG holter device (Biomonitor3, Biotronik)
Intervention Description
Subcutaneous implantation of ECG holder device to monitor ECG
Primary Outcome Measure Information:
Title
Rate of recurrence of atrial fibrillation
Description
Any episode of atrial fibrillation, atrial tachycardia or atrial flutter lasting at least 1 minute, as documented on the implantable device recordings
Time Frame
up to 1 year after ICU discharge
Secondary Outcome Measure Information:
Title
Burden of atrial fibrillation in absolute value
Description
Burden of atrial fibrillation assessed as time (in days, hours and minutes), expressed as a absolute value
Time Frame
up to 2 years after ICU discharge
Title
Burden of atrial fibrillation (percentage of time spent in atrial fibrillation)
Description
Burden of atrial fibrillation assessed as time (in days, hours and minutes) expressed as a percentage time spent in atrial fibrillation
Time Frame
up to 2 years after ICU discharge
Title
Rate of Stroke
Description
Ischemic or hemorrhagei stroke documented by imaging, major bleeding (ISTH classification) or documented peripheral emboli
Time Frame
up to 2 years after ICU discharge
Title
Number of participants with Change in treatment
Description
Changes in treatment due to the discovery of atrial fibrillation
Time Frame
up to 2 years after ICU discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Monnin, MD
Phone
33381668186
Email
charles.monnin@edu.univ-fcomte.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Elise Robert
Phone
33381219086
Email
e1robert@chu-besancon.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Besancon
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Monnin, MD
Email
charles.monnin@edu.univ-fcomte.fr
First Name & Middle Initial & Last Name & Degree
Marc Badoz, MD
Email
mbadoz@chu-besancon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Post Intensive Care Unit Atrial Fibrillation

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