Atrial FibrillationPIAFNCT05860894
Post Intensive Care Unit Atrial Fibrillation
A study testing Implantable ECG holter device (Biomonitor3, Biotronik) in people with Atrial Fibrillation and Critical Illness, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Critical Illness
- What is being tested?
- Implantable ECG holter device (Biomonitor3, Biotronik)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2023to 10 Apr 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Critical Illness
- Being tested
- Implantable ECG holter device (Biomonitor3, Biotronik)
- Keywords
- intensive care unit, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable ECG holter device (Biomonitor3, Biotronik)Device
Subcutaneous implantation of ECG holder device to monitor ECG
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Implantable ECG holter device (Biomonitor3, Biotronik) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 year after ICU discharge
Secondary outcomes (4)
Burden of atrial fibrillation in absolute value
Burden of atrial fibrillation assessed as time (in days, hours and minutes), expressed as a absolute value
Measured: 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
Measured: 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
Measured: up to 2 years after ICU discharge
Number of participants with Change in treatment
Changes in treatment due to the discovery of atrial fibrillation
Measured: up to 2 years after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start19 Sep 2023
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860894
- Sponsor's protocol ID
- 2022-A01292-41
- Acronym
- PIAF
- Status last verified
- Sep 2025
- First submitted
- 27 Jan 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No