New Onset Atrial FibrillationPAF-ICUNCT03977883
Management of Paroxystic Atrial Fibrillation in French Intensive Care Units
An observational study of New Onset Atrial Fibrillation and ICU Patients, run by University Hospital, Clermont-Ferrand at 32 sites in France.
Trial summary
The primary purpose of the study is to evaluate treatment of new onset atrial fibrillation in french ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- New Onset Atrial Fibrillation, ICU Patients
- How many people
- 742 participants
- Where
- 32 sitesFrance
- Study dates
- 13 May 2019to 27 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients hospitalized in French ICU
Who may be able to join
- Age > 18 years
- Patient hospitalized in ICU
- New onset atrial fibrillation
Who cannot join
- Age < 18 years
- Parturient or breast-feeding woman
- Persistent or permanent atrial fibrillation
- Patients after cardiovascular or thoracic surgery
- Patients with therapeutic limitations
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
France32 sites
CHU
Amiens
CHU
Angers
CH
Argenteuil
CHU
Besançon
CHU
Bordeau
CH
Bourgoin
Hôpital d'Instruction des Armées
Brest
CH
Cholet
CHU
Clermont-Ferrand
CH
Dax
CHU
Dijon
CH
Eaubonne
CHU
Grenoble
CHU
Lille
Hôpital du Scorff
Lorient
APHM
Marseille
Hôpital Saint-Joseph
Marseille
La Timone APHM
Marseille
Institut Régional du Cancer de Montpellier
Montpellier
CHU
Nancy
CHU
Nantes
CHU
Nice
Clinique médicale les Sources
Nice
CHU
Nîmes
Groupe Hospitalier Saint Joseph
Paris
Hôpital Bichat
Paris
Hôpital Henri Mondor
Paris
Hôpital La Pitié Salpêtrière
Paris
Hôpital Saint-Louis
Paris
CHU
Rennes
CHU
Saint-Etienne
CHU
Toulouse
About this study
The primary purpose of the study is to evaluate treatment of new onset atrial fibrillation in french ICU.
Read the detailed description
Atrial fibrillation (AF) is a common arrhythmia in the ICU and is associated with significant morbidity. However, curative treatment remains unclearly established. In fact, there are no specific recommendations for new onset atrial fibrillation in ICU and only few studies have assessed this topic.
The PAF-ICU trial is an observational, prospective, multicenter, transversal trial. The main objective is to evaluate the management of paroxytic atrial fibrillation that occur in ICU.
The investigators want to document 2500 episodes of paroxystic atrial fibrillation in 50 ICU centers. In each center, the episodes are included consecutively until the required 50 episodes are obtained for each center.
A patient can present several episodes and each episode can be included in the study. A new episode is considered as such if it occurs more than one hour after the previous episode.
The follow-up period for each patient corresponds to the ICU stay.
- Conditions
- New Onset Atrial Fibrillation, ICU Patients
- Keywords
- New onset atrial fibrillation, Paroxystic atrial fibrillation, ICU patients, Rate control, Rhythm control
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of Atrial Fibrillation
All types of therapeutics used to manage atrial fibrillation are collected
Measured: ICU stay (until 28 days)
Secondary outcomes (7)
Cardiac rhythm status
Type of rhythm : Normal (sinus rhythm), Atrial Fibrillation, Other disturbance
Measured: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Blood pressure
Blood pressure. Unit : Millimeters of mercury
Measured: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Heart rate
Heart rate. Unit : beats per minute
Measured: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Cardiac output
Product of the heart rate (HR) and the stroke volume (SV), which is the volume of blood pumped from the ventricle per beat. Unit : L/min.
Measured: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
ScvO2
Venous saturation. Unit : percentage
Measured: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Vasopressors
Type of vasopressors used
Measured: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Stroke
Occurrence of stroke during ICU stay
Measured: ICU Stay up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start13 May 2019
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for New Onset Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 742 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- French Society of Anesthesia and Intensive Care Medecine
- Responsible party
- Sponsor
- Investigators
- Jean-Michel Constantin, Study director, Réa Adulte CHU Clermont-FerrandBernard Cosserant, Principal investigator, Neuro-Réa CHU Clermont-FerrandRaiko Blondonnet, Principal investigator, RMC CHU Clermont-FerrandEric Kipnis, Principal investigator, CHU LilleJonathan Paillot, Principal investigator, CHU BesancçonCharles Vidal, Principal investigator, CHU de la RéunionLaurent Muller, Principal investigator, CHU NimesJohann Auchabie, Principal investigator, CH Cholet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977883
- Sponsor's protocol ID
- PAF-ICU - RNI 2018 CONSTANTIN
- Acronym
- PAF-ICU
- Status last verified
- Aug 2021
- First submitted
- 29 May 2019
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pardo E, Futier E, Muller L, Besch G, Vardon-Bounes F, Kipnis E, Lasocki S, Ledochowski S, Ochin E, Bourenne J, Grillet G, Auvet A, Mekontso Dessap A, Bruel C, Launey Y, Fiorillo M, Jabaudon M, Godet T, Mulliez A, Constantin JM; SFAR Research Network. Management of new-onset atrial fibrillation in critically ill patients: A national multicenter prospective cohort. Anaesth Crit Care Pain Med. 2026 Jan;45(1):101617. doi: 10.1016/j.accpm.2025.101617. Epub 2025 Sep 26.
PubMed 41016469
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Paroxystic Atrial Fibrillation in French Intensive Care Units
- ClinicalTrials.gov ID
- NCT03977883
- Acronym / sponsor ID
- PAF-ICU / PAF-ICU - RNI 2018 CONSTANTIN
- Conditions
- New Onset Atrial Fibrillation, ICU Patients
- Keywords
- New onset atrial fibrillation, Paroxystic atrial fibrillation, ICU patients, Rate control, Rhythm control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 742 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- French Society of Anesthesia and Intensive Care Medecine
- Study start
- 13 May 2019 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to evaluate treatment of new onset atrial fibrillation in french ICU.
Detailed description
Atrial fibrillation (AF) is a common arrhythmia in the ICU and is associated with significant morbidity. However, curative treatment remains unclearly established. In fact, there are no specific recommendations for new onset atrial fibrillation in ICU and only few studies have assessed this topic.
The PAF-ICU trial is an observational, prospective, multicenter, transversal trial. The main objective is to evaluate the management of paroxytic atrial fibrillation that occur in ICU.
The investigators want to document 2500 episodes of paroxystic atrial fibrillation in 50 ICU centers. In each center, the episodes are included consecutively until the required 50 episodes are obtained for each center.
A patient can present several episodes and each episode can be included in the study. A new episode is considered as such if it occurs more than one hour after the previous episode.
The follow-up period for each patient corresponds to the ICU stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in French ICU
Key inclusion criteria (3 listed)
- Age > 18 years
- Patient hospitalized in ICU
- New onset atrial fibrillation
Key exclusion criteria (5 listed)
- Age < 18 years
- Parturient or breast-feeding woman
- Persistent or permanent atrial fibrillation
- Patients after cardiovascular or thoracic surgery
- Patients with therapeutic limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Management of Atrial Fibrillation
Time frame: ICU stay (until 28 days)
All types of therapeutics used to manage atrial fibrillation are collected
7 secondary outcomes
Cardiac rhythm status
Time frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Blood pressure
Time frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Heart rate
Time frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Cardiac output
Time frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
ScvO2
Time frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Vasopressors
Time frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Stroke
Time frame: ICU Stay up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 41016469Pardo E, Futier E, Muller L, Besch G, Vardon-Bounes F, Kipnis E, Lasocki S, Ledochowski S, Ochin E, Bourenne J, Grillet G, Auvet A, Mekontso Dessap A, Bruel C, Launey Y, Fiorillo M, Jabaudon M, Godet T, Mulliez A, Constantin JM; SFAR Research Network. Management of new-onset atrial fibrillation in critically ill patients: A national multicenter prospective cohort. Anaesth Crit Care Pain Med. 2026 Jan;45(1):101617. doi: 10.1016/j.accpm.2025.101617. Epub 2025 Sep 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel Constantin study director
Réa Adulte CHU Clermont-Ferrand
Bernard Cosserant principal investigator
Neuro-Réa CHU Clermont-Ferrand
Raiko Blondonnet principal investigator
RMC CHU Clermont-Ferrand
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of New Onset Atrial Fibrillation and ICU Patients, run by University Hospital, Clermont-Ferrand at 32 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Management of Atrial Fibrillation (time frame: ICU stay (until 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03977883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.