Post Intensive Care Unit Atrial Fibrillation

NCT05860894 | Recruiting

• 1 other identifier: 2022-A01292-41
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Critical Illness

Keywords

intensive care unit; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Burden of atrial fibrillation in absolute value

  up to 2 years after ICU discharge

• Burden of atrial fibrillation (percentage of time spent in atrial fibrillation)

  up to 2 years after ICU discharge

• Rate of Stroke

  up to 2 years after ICU discharge

• Number of participants with Change in treatment

  up to 2 years after ICU discharge

Study Arms (1)

Implantable ECG holter device

EXPERIMENTAL

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)

Interventions

Implantable ECG holter device (Biomonitor3, Biotronik) DEVICE

Subcutaneous implantation of ECG holder device to monitor ECG

Implantable ECG holter device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Biotronik SE & Co. KG: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Besancon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Critical Illness

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Central Study Contacts

Charles Monnin, MD

CONTACT

33381668186; charles.monnin@edu.univ-fcomte.fr

Elise Robert

CONTACT

33381219086; e1robert@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: May 16, 2023
• Study Start: September 19, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)