Postoperative Atrial FibrillationIRM-FAPONCT04657835
Multiparametric MRI Assessment of Atrial Heart Disease as a Predictor of Atrial Fibrillation After Myocardial Revascularization Surgery
A study testing 4D cardiac MRI with gadoteric acid, Blood sample and Implantable Loop Recorder (ILR) in people with Postoperative Atrial Fibrillation, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Postoperative atrial fibrillation (POAF) occurs in 20-40% of patients undergoing coronary artery bypass grafting (CABG) and is a marker of atrial vulnerability. It is strongly associated with AF recurrence, stroke, and cardiovascular mortality. It presents risk factors with atrial heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Atrial Fibrillation
- What is being tested?
- 4D cardiac MRI with gadoteric acid, Blood sample and Implantable Loop Recorder (ILR)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- Indication for surgical myocardial revascularization by isolated coronary artery bypass grafting, to be performed in the cardiac surgery department of Saint-Étienne University Hospital.
- Patient affiliated with or entitled to social security coverage
- Patient who has received informed information about the study and has co-signed, with the investigator, a consent form to participate in the study
Who cannot join
- Contraindication related to cardiac MRI
- Contraindication related to ILR implantation
- Documented history of atrial fibrillation
- Concomitant indication for valve surgery or other associated cardiac intervention
- Inability to understand French
- Patient refusal to participate in the study and/or inability to express consent or sign the informed consent form
- Patient subject to legal protection measures
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
CHU Saint-Etienne
Saint-Etienne, 42055
Karim BENALI, MD, (0)477828679 ext. +33, karim.benali@chu-st-etienne.fr
Jean-Baptiste GUICHARD, MD, jbguichard@clinic.cat
About this study
Postoperative atrial fibrillation (POAF) occurs in 20-40% of patients undergoing coronary artery bypass grafting (CABG) and is a marker of atrial vulnerability. It is strongly associated with AF recurrence, stroke, and cardiovascular mortality. It presents risk factors with atrial heart disease.
The latter refers to all structural, electrical, and mechanical alterations of the atrium that create a substrate conducive to AF.
Multiparametric cardiac MRI is currently the most comprehensive test for assessing atrial heart disease, thanks to its structural and functional analysis (atrial fibrosis, atrial strain, intracavitary 4D flow). However, to date, no prospective study has evaluated these parameters as predictors of AF recurrence after CAP. At the same time, an implantable Holter monitor will be used to enable detailed and continuous detection of recurrence episodes, overcoming the limitations of conventional monitoring strategies. By combining multiparametric imaging, histological analysis, and continuous monitoring for the first time, this study proposes a paradigm shift in the assessment of postoperative AF: moving from a descriptive and ad hoc approach to a mechanistic, integrative, and predictive approach.
- Conditions
- Postoperative Atrial Fibrillation
- Being tested
- 4D cardiac MRI with gadoteric acid, Blood sample, Implantable Loop Recorder (ILR), Right atrial biopsy
- Keywords
- magnetic resonance imaging, implantable holter monitor, atrial heart disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D cardiac MRI with gadoteric acidDevice
Also called 4D flow Magnetic Resonance Imaging with Late Gadolinium Enhancement
4D cardiac MRI with gadoteric acid injection will be performed prior the surgery, according to a standardized technical protocol.
Blood sampleBiological
Peripheral venous blood sample (1 x 6 ml EDTA tube): taken during preoperative assessment to measure inflammatory biomarkers (CRP, IL-1, TNF-α).
Implantable Loop Recorder (ILR)Device
Implantation of a Holter monitor (Implantable Loop Recorder) prior to surgery, performed preoperatively under local anesthesia.
The ILR will enable continuous recording of the heart rhythm for 12 months with automatic data transmission via remote monitoring. The minimally invasive procedure will be performed by an experienced cardiologist under the usual safety conditions.
Right atrial biopsyProcedure or surgery
During the surgical procedure (coronary artery bypass grafting), a right atrial biopsy will be performed using a brief, low-risk procedure on a small tissue sample. The sample will be analyzed using Masson's trichrome staining to assess atrial fibrosis.
| Study group | Role | What they receive |
|---|---|---|
| Myocardial revascularization cardiac surgery by coronary artery bypass grafting | Experimental | Patient with indication of Coronary Artery Bypass Grafting will be included. They will have:
* before surgery : 4D cardiac MRI with gadoteric acid + ILR implantation + blood sampling
* during surgery : right atrial biopsy
* after surgery : Continuous monitoring by ILR for 12 months + scheduled clinical consultation (at 12 months) Receives: Device: 4D cardiac MRI with gadoteric acid; Biological: Blood sample; Device: Implantable Loop Recorder (ILR); Procedure: Right atrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the predictive value of atrial heart disease characterized by multiparametric MRI (late enhancement fibrosis, atrial strain, and exploratory 4D flow parameters) for the recurrence of atrial fibrillation documented by Implantable Loop Recorder.
Recurrence of atrial fibrillation, defined as an episode lasting ≥ 30 seconds documented by the Implantable Loop Recorder (ILR) implanted preoperatively and recorded during the 12-month follow-up period.
Measured: through study completion, an average of 12 months
Secondary outcomes (5)
Evaluate the link between atrial heart disease characterized by MRI (fibrosis, strain, 4D flow) and the occurrence of postoperative atrial fibrillation (POAF) during the first week following coronary artery bypass grafting.
POAF will be defined as an episode of AF ≥ 30 seconds, detected by the preoperatively implanted ILR and recorded during the first postoperative week.
Measured: through the first postoperative week
Correlate MRI parameters of atrial remodeling with histological assessment of fibrosis on intraoperative atrial biopsy
Percentage of histological fibrosis. Analysis of atrial fibrosis using Masson's trichrome staining on intraoperative atrial biopsy (normal threshold ≤ 10%). The objective is to establish a correlation between histological data and MRI parameters.
Measured: through the first postoperative week
Exploring the value of atrial hemodynamic parameters obtained by 4D flow MRI (vorticity, intra-atrial velocities) as predictive markers of atrial fibrillation
measurement of intra-auricular blood flow using 4D-flow MRI, including velocities (cm/s), flow volumes (mL/s or mL), and vorticity indices (s-¹)
Measured: Before the surgery
To study the association between serum inflammatory biomarkers (CRP, IL-1, TNF-α) and Atrial Fibrillation recurrence.
Preoperative measurement of pro-inflammatory cytokines (IL-1, TNF-α, CRP).
Measured: before the surgery
Determine the impact of atrial fibrillation recurrence documented by ILR on the occurrence of major cardiovascular events
Number of ischemic strokes, hospitalizations for heart failure, cardiovascular deaths occurring within one year of surgery, and all-cause deaths.
Measured: through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Oct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (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 de Saint EtienneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-center pilot study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste GUICHARD, MD, Study director, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657835
- Sponsor's protocol ID
- 20CH027
- Other IDs
- ANSM
- Acronym
- IRM-FAPO
- Status last verified
- Oct 2026
- First submitted
- 24 Nov 2020
- Last updated
- 7 Oct 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric MRI Assessment of Atrial Heart Disease as a Predictor of Atrial Fibrillation After Myocardial Revascularization Surgery
- ClinicalTrials.gov ID
- NCT04657835
- Acronym / sponsor ID
- IRM-FAPO / 20CH027
- Conditions
- Postoperative Atrial Fibrillation
- Keywords
- magnetic resonance imaging, implantable holter monitor, atrial heart disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Dec 2020 (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.
Postoperative atrial fibrillation (POAF) occurs in 20-40% of patients undergoing coronary artery bypass grafting (CABG) and is a marker of atrial vulnerability. It is strongly associated with AF recurrence, stroke, and cardiovascular mortality. It presents risk factors with atrial heart disease.
The latter refers to all structural, electrical, and mechanical alterations of the atrium that create a substrate conducive to AF.
Multiparametric cardiac MRI is currently the most comprehensive test for assessing atrial heart disease, thanks to its structural and functional analysis (atrial fibrosis, atrial strain, intracavitary 4D flow). However, to date, no prospective study has evaluated these parameters as predictors of AF recurrence after CAP. At the same time, an implantable Holter monitor will be used to enable detailed and continuous detection of recurrence episodes, overcoming the limitations of conventional monitoring strategies. By combining multiparametric imaging, histological analysis, and continuous monitoring for the first time, this study proposes a paradigm shift in the assessment of postoperative AF: moving from a descriptive and ad hoc approach to a mechanistic, integrative, and predictive approach.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-center pilot study
| Arm | Type | Receives |
|---|---|---|
| Myocardial revascularization cardiac surgery by coronary artery bypass grafting | Experimental | Device: 4D cardiac MRI with gadoteric acid, Biological: Blood sample, Device: Implantable Loop Recorder (ILR), Procedure: Right atrial biopsyPatient with indication of Coronary Artery Bypass Grafting will be included. They will have: * before surgery : 4D cardiac MRI with gadoteric acid + ILR implantation + blood sampling * during surgery : right atrial biopsy * after surgery : Continuous monitoring by ILR for 12 months + scheduled clinical consultation (at 12 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Indication for surgical myocardial revascularization by isolated coronary artery bypass grafting, to be performed in the cardiac surgery department of Saint-Étienne University Hospital.
- Patient affiliated with or entitled to social security coverage
- Patient who has received informed information about the study and has co-signed, with the investigator, a consent form to participate in the study
Key exclusion criteria (7 listed)
- Contraindication related to cardiac MRI
- Contraindication related to ILR implantation
- Documented history of atrial fibrillation
- Concomitant indication for valve surgery or other associated cardiac intervention
- Inability to understand French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4D cardiac MRI with gadoteric acidAlso: 4D flow Magnetic Resonance Imaging with Late Gadolinium Enhancement4D cardiac MRI with gadoteric acid injection will be performed prior the surgery, according to a standardized technical protocol. | Device | Myocardial revascularization cardiac surgery by coronary artery bypass grafting |
| Blood samplePeripheral venous blood sample (1 x 6 ml EDTA tube): taken during preoperative assessment to measure inflammatory biomarkers (CRP, IL-1, TNF-α). | Biological | Myocardial revascularization cardiac surgery by coronary artery bypass grafting |
| Implantable Loop Recorder (ILR)Implantation of a Holter monitor (Implantable Loop Recorder) prior to surgery, performed preoperatively under local anesthesia. The ILR will enable continuous recording of the heart rhythm for 12 months with automatic data transmission via remote monitoring. The minimally invasive procedure will be performed by an experienced cardiologist under the usual safety conditions. | Device | Myocardial revascularization cardiac surgery by coronary artery bypass grafting |
| Right atrial biopsyDuring the surgical procedure (coronary artery bypass grafting), a right atrial biopsy will be performed using a brief, low-risk procedure on a small tissue sample. The sample will be analyzed using Masson's trichrome staining to assess atrial fibrosis. | Procedure or surgery | Myocardial revascularization cardiac surgery by coronary artery bypass grafting |
Primary outcome
Evaluate the predictive value of atrial heart disease characterized by multiparametric MRI (late enhancement fibrosis, atrial strain, and exploratory 4D flow parameters) for the recurrence of atrial fibrillation documented by Implantable Loop Recorder.
Time frame: through study completion, an average of 12 months
Recurrence of atrial fibrillation, defined as an episode lasting ≥ 30 seconds documented by the Implantable Loop Recorder (ILR) implanted preoperatively and recorded during the 12-month follow-up period.
5 secondary outcomes
Evaluate the link between atrial heart disease characterized by MRI (fibrosis, strain, 4D flow) and the occurrence of postoperative atrial fibrillation (POAF) during the first week following coronary artery bypass grafting.
Time frame: through the first postoperative week
Correlate MRI parameters of atrial remodeling with histological assessment of fibrosis on intraoperative atrial biopsy
Time frame: through the first postoperative week
Exploring the value of atrial hemodynamic parameters obtained by 4D flow MRI (vorticity, intra-atrial velocities) as predictive markers of atrial fibrillation
Time frame: Before the surgery
To study the association between serum inflammatory biomarkers (CRP, IL-1, TNF-α) and Atrial Fibrillation recurrence.
Time frame: before the surgery
Determine the impact of atrial fibrillation recurrence documented by ILR on the occurrence of major cardiovascular events
Time frame: through study completion, an average of 12 months
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 7 Oct 2026.
- Individual participant dataSharing planned: No
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Atrial Fibrillation
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.
Jean-Baptiste GUICHARD, MD study director
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4D cardiac MRI with gadoteric acid, Blood sample and Implantable Loop Recorder (ILR) in people with Postoperative Atrial Fibrillation, run by Centre Hospitalier Universitaire de Saint Etienne 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 7 Oct 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 Karim Benali, MD ((0)477828679 ext. +33, karim.benali@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the predictive value of atrial heart disease characterized by multiparametric MRI (late enhancement fibrosis, atrial strain, and exploratory 4D flow parameters) for the recurrence of atrial fibrillation documented by Implantable Loop Recorder. (time frame: through study completion, an average of 12 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 7 Oct 2026.