Postoperative Atrial FibrillationODFAPONCT06054360
Predictive Value of Right Atrial Strain in Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
An observational study of Postoperative Atrial Fibrillation and Strains, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The incidence of postoperative atrial fibrillation (POAF) after cardiac surgery is around 30%. POAF increases the risk of developing permanent atrial fibrillation and raises the risk of cardiac decompensation, stroke, acute myocardial infarction, and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Atrial Fibrillation, Strains
- How many people
- 334 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2023to 9 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: This prospective, single-center study was conducted at the Amiens University Hospital. As an additional procedure to the patient's management, it includes the systematic performance of a TTE the day before the surgery, with the acquisition of specific views to measure RAS. After enrollment, the principal investigator will perform a TTE to measure RASr on particular views. TTE will be performed in a supine position at the patient's bedside by a trained medical operator, following a standardized protocol. After surgery, the patient will be monitored by a 5-lead ECG to diagnose POAF. The maximum duration of POAF monitoring will be seven days in the intensive care unit.
Who may be able to join
- Adult patient (>18 years old)
- The patient was hospitalized at the Amiens University Hospital for scheduled aortocoronary bypass grafting under cardiopulmonary bypass.
- Echocardiographic image quality enabling the measurement of RAS parameters
- Patient affiliation to a social security scheme
- Patient/proxy information and collection of their non-opposition.
Who cannot join
- Patients participating in an interventional study may modify the incidence of POAF.
- History of atrial fibrillation or flutter.
- Valvular and ascending aorta cardiac surgery
- Urgent cardiac surgery.
- Presence of tricuspid insufficiency greater than grade 2.
- Left ventricular ejection fraction lower than 50%.
- Patient receiving circulatory mechanical assistance before surgery.
- Dependency on ventricular and atrial pacing by an internal or external cardiac pacemaker during the echocardiographic examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens
Camille DAUMIN, MD, 03 22 08 77 95, daumin.camille@chu-amiens.fr
Christophe Beyls, MD
About this study
The incidence of postoperative atrial fibrillation (POAF) after cardiac surgery is around 30%. POAF increases the risk of developing permanent atrial fibrillation and raises the risk of cardiac decompensation, stroke, acute myocardial infarction, and death. While the role of the left atrium (LAF) in the pathophysiology of POAF is now well-established, the part of the right atrium (RA) remains poorly understood. Recent studies suggest a correlation between RA function and POAF.
RA function can be assessed by transthoracic echocardiography (TTE) with dedicated software for measuring the RA strain (RAS). RA function is thus divided into three phases: reservoir (RASr), conduit, and contraction. Numerous studies have demonstrated that a significant alteration in RAS predicts POAF in various clinical contexts. Therefore, it is essential to investigate whether alterations in RA function assessed by 2D-STE (RAS) are associated with an increased occurrence of FAPO after cardiac surgery.
It is essential to investigate whether alterations in RA function assessed by 2D-STE (RAS) are associated with an increased occurrence of FAPO after cardiac surgery.
- Conditions
- Postoperative Atrial Fibrillation, Strains
- Keywords
- coronary bypass grafting, postoperative atrial fibrillation, strain, left atrial, right atrial
- Medical subject headings
- Sprains and Strains
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of RASr parameter variation with POAF incidence
Correlation of RASr parameter variation with POAF incidence in patients undergoing postoperative cardiac surgery
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start9 Oct 2023
- Primary completion9 Oct 2026 (estimated)
- Study completion9 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054360
- Sponsor's protocol ID
- PI2023_843_0048
- Acronym
- ODFAPO
- Status last verified
- May 2026
- First submitted
- 19 Sep 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Right Atrial Strain in Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06054360
- Acronym / sponsor ID
- ODFAPO / PI2023_843_0048
- Conditions
- Postoperative Atrial Fibrillation, Strains
- Keywords
- coronary bypass grafting, postoperative atrial fibrillation, strain, left atrial, right atrial
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 9 Oct 2026 (estimated)
- Study completion
- 9 Oct 2026 (estimated)
- First posted
- 26 Sep 2023 (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 incidence of postoperative atrial fibrillation (POAF) after cardiac surgery is around 30%. POAF increases the risk of developing permanent atrial fibrillation and raises the risk of cardiac decompensation, stroke, acute myocardial infarction, and death. While the role of the left atrium (LAF) in the pathophysiology of POAF is now well-established, the part of the right atrium (RA) remains poorly understood. Recent studies suggest a correlation between RA function and POAF.
RA function can be assessed by transthoracic echocardiography (TTE) with dedicated software for measuring the RA strain (RAS). RA function is thus divided into three phases: reservoir (RASr), conduit, and contraction. Numerous studies have demonstrated that a significant alteration in RAS predicts POAF in various clinical contexts. Therefore, it is essential to investigate whether alterations in RA function assessed by 2D-STE (RAS) are associated with an increased occurrence of FAPO after cardiac surgery.
It is essential to investigate whether alterations in RA function assessed by 2D-STE (RAS) are associated with an increased occurrence of FAPO after cardiac surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective, single-center study was conducted at the Amiens University Hospital. As an additional procedure to the patient's management, it includes the systematic performance of a TTE the day before the surgery, with the acquisition of specific views to measure RAS. After enrollment, the principal investigator will perform a TTE to measure RASr on particular views. TTE will be performed in a supine position at the patient's bedside by a trained medical operator, following a standardized protocol. After surgery, the patient will be monitored by a 5-lead ECG to diagnose POAF. The maximum duration of POAF monitoring will be seven days in the intensive care unit.
Key inclusion criteria (5 listed)
- Adult patient (>18 years old)
- The patient was hospitalized at the Amiens University Hospital for scheduled aortocoronary bypass grafting under cardiopulmonary bypass.
- Echocardiographic image quality enabling the measurement of RAS parameters
- Patient affiliation to a social security scheme
- Patient/proxy information and collection of their non-opposition.
Key exclusion criteria (8 listed)
- Patients participating in an interventional study may modify the incidence of POAF.
- History of atrial fibrillation or flutter.
- Valvular and ascending aorta cardiac surgery
- Urgent cardiac surgery.
- Presence of tricuspid insufficiency greater than grade 2.
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
Correlation of RASr parameter variation with POAF incidence
Time frame: 30 months
Correlation of RASr parameter variation with POAF incidence in patients undergoing postoperative cardiac surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Atrial Fibrillation and Strains, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camille DAUMIN, MD (03 22 08 77 95, daumin.camille@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of RASr parameter variation with POAF incidence (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.