Atrial Fibrillation (AF)Phase 3PREV-AFNCT07887022
Randomized Interventional Clinical Trial on the Prevention of Atrial Fibrillation Using Colchicine, Amiodarone And a Posterior Pericardiotomy.
A Phase 3 study testing Colchicine, Amiodarone and Posterior pericardiotomy in people with Atrial Fibrillation (AF), run by Elsan at 3 sites in France.
Trial summary
The goal of this clinical trial is to learn if a bundle of three treatments can prevent atrial fibrillation, a heart rhythm disorder often observed in adults following heart surgery. Atrial fibrillation is associated with increased risks of stroke and heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Colchicine, Amiodarone and Posterior pericardiotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 636 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2027to Jan 2032
- Phase
- Phase 3
- 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
- Adult patient (≥ 18 years old) hospitalized for aortic, coronary, ascending aortic or combined valvular heart surgery
- Patient understands French
- Patient affiliated with the French Social Security
- Patient has given a written informed consent
Who cannot join
- Patient who are part of a vulnerable population (including pregnant women and patients under guardianship or trusteeship)
- Current treatment by amiodarone or colchicine
- Patient who will receive emergency surgery (< 24h)
- Patient who will receive mitral or tricuspid valve surgery
- Patient who will receive Transcatheter Aortic Valve Implantation (TAVI)
- Patient with active sepsis (endocarditis)
Show all 16Show fewer
- Patient with a history of atrial fibrillation
- Patient who refuses access to his/her personal data for quality control
- Patient treated with immunosuppressive therapy (for example cyclosporine)
- Women of childbearing potential who are sexually active in a heterosexual relationship and not using a highly effective method of contraception
- Patient presenting a contraindication to the posterior pericardial window
- Patient presenting a contraindication to colchicine
- Patient presenting a contraindication to amiodarone
- Known hypersensitivity to iodine or amiodarone or any of the excipients listed in the SmPC
- Breastfeeding
- Patients under treatment with drugs that interact with amiodarone
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Clinique Saint-Augustin
Bordeaux, 33200
Marc-Olivier Fischer, Dr, +33556003030, recherche.na@elsan.care
Hôpital privé Les Franciscaines
Nîmes, 30000
Walid Ghodbane, Dr, +33130973333, recherche.na@elsan.care
Clinique Saint-Pierre
Perpignan, 66000
Daniel Carbognani, Dr, +33468562626, recherche.na@elsan.care
About this study
Official title: Multicenter and Randomized Study on Atrial Fibrillation Prevention After Cardiac Surgery With a 3-Way Comparison Between Standard of Care, Posterior Pericardiotomy and a Treatment Bundle (Colchicine, Amiodarone and Posterior Pericardiotomy)
The goal of this clinical trial is to learn if a bundle of three treatments can prevent atrial fibrillation, a heart rhythm disorder often observed in adults following heart surgery. Atrial fibrillation is associated with increased risks of stroke and heart failure. The bundle consists of two drugs (colchicine and amiodarone) as well as a simple surgical technique called posterior pericardiotomy. The main question it aims to answer is whether this bundle can reduce the incidence of atrial fibrillation after heart surgery.
Researchers will compare the results from this bundle of treatment to two other groups, one treated only with the posterior pericardiotomy and one treated following standard of care.
Participants, depending on their group, may receive colchicine and amiodarone before and just after heart surgery and the posterior pericardiotomy will be performed at the same time as the heart surgery.
Read the detailed description
Atrial fibrillation (AF) is an irregular and often very rapid heart rhythm, and it is one of the most commonly encountered heart conditions. AF is defined as a supraventricular arrhythmia with uncoordinated atrial activation, which results in a loss of effective atrial contraction (Van Gelder et al. 2024). AF has been associated with increased risks of stroke and heart failure as well as subclinical cerebral damage (potentially leading to vascular dementia), and thromboembolism to every other organ (Van Gelder et al. 2024). POAF is associated with worsening prognostics as it is linked with prolonged hospital stay, haemodynamic instability, an increased risk of stroke, and increased mortality (Maesen et al. 2012; Caldonazo et al. 2023). The strongest predictor of POAF is increasing age, other predictors are more difficult to define as they are not always significantly correlated with POAF (Maesen et al. 2012).
Studies have assessed many different medical strategies to decrease POAF's incidence after cardiac surgery, resulting in a wide variety of treatments and prevention strategies that do not necessarily have robust proof of a positive effect. The goal of this study is to obtain more conclusive proof on the efficacy and safety of a treatment bundle in preventing POAF's incidence. This bundle will include treatment with amiodarone and colchicine as well as a surgical procedure (posterior pericardiotomy).
Amiodarone is an anti-arrhythmia treatment that has proven effective in POAF's prevention (Chatterjee et al. 2013). However, in Europe, it is rarely used for PAOF's prevention due to adverse events, including heart conduction disorders (Emiola et al. 2024). Low doses of amiodarone over a short period of time could help prevent POAF while decreasing the incidence of adverse events (Van Gelder et al. 2024). Amiodarone is sometimes used in combination with beta-blockers (Auer et al. 2004; Polintan et al. 2023). However, we have recently demonstrated that the use of beta-blockers during cardiac surgery can increase the incidence of postoperative acute renal failure and might not prevent POAF. Their use should remain cautious peri-operatively in the context of these high-risk surgeries (Guinot et al. 2024; Fischer et Guinot 2024).
Colchicine has an anti-inflammatory and anti-arrhythmic action by inhibiting microtubular depolymerization of the calcium channels involved in tachyarrhythmias. A recent meta-analysis highlights its efficacy in preventing POAF (Agarwal et al. 2023) and in some cases even for short treatment durations (5 days peri-operatively) (Shvartz et al. 2022).
The posterior pericardial window is a quick surgical technique (<5 min) that helps drain pericardial fluid into the left pleura by making a 4-5 cm incision in the posterior pericardium opposite the left inferior pulmonary vein, towards the diaphragm, and parallel to the phrenic nerve. The advantage of this technique is that it avoids the accumulation of fluid opposite the left atrium, which can induce POAF, especially as postoperative pericardial fluid is itself highly inflammatory (Abouarab et al. 2017). A recent randomized study showed a significant reduction in POAF's incidence in patients who benefited from this procedure compared to patients who did not (Gaudino et al. 2021). However, no other randomized study has yet confirmed these results.
The originality of this study project lies in the evaluation of a "preventive treatment bundle" to reduce the incidence of POAF after cardiac surgery compared to the standard of care (which includes treatment with amiodarone and beta-blockers in case of POAF). This study will also compare the use of a posterior pericardial window with the standard of care. This will help to differentiate the impact of the posterior pericardial window versus the preventive treatment with amiodarone and colchicine on the incidence of POAF.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Colchicine, Amiodarone, Posterior pericardiotomy
- Keywords
- prevention, atrial fibrillation, colchicine, amiodarone, posterior pericardiotomy, auricular fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
The dosage will be 1mg PO on D-1, followed by 1mg/day PO from D1 to D5 (stopped in case of diarrhoea). This represents a maximum total dose of 6mg.
If the patient is older than 75 years old or if the patient's weight is less than 70kg, then the daily dosage will be 0.5mg.
AmiodaroneDrug
400mg/day per os (PO) on D-1 and D0, followed by 200mg/day PO from D1 to D5 if the heart rate is equal or superior to 70 beats/min. If the heart rate is inferior to 70 beats/min then the treatment will not be given. This represents a maximum total dose of 1800mg.
Posterior pericardiotomyProcedure or surgery
The procedure will be done similarly to previously published studies (Mulay et al. 1995; Gaudino et al. 2021). The left pleural space will be entered through the pre-existing median sternotomy. A 4-cm incision will be made posterior to the phrenic nerve in a parallel and longitudinal fashion extending from the left inferior pulmonary vein to the diaphragm. We will use the tip of the mediastinal tube that is placed in all cardiac surgery patients (instead of an additional chest tube) for drainage of the left-sided pleura so that patients in the treatment group will not have a higher level of postoperative pain or discomfort. The estimated additional surgery time is less than 5 min (Abouarab et al. 2017).
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SoC) | No intervention | Not described |
| Posterior pericardiotomy alone | Active comparator | Patients will be treated following standard of care with the addition of the posterior pericardiotomy performed during the planned surgery. Receives: Procedure: Posterior pericardiotomy |
| Treatment bundle | Experimental | Patients will receive amiodarone and colchicine for prevention and the posterior pericardial window will be performed during the surgery. Receives: Drug: Colchicine; Drug: Amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the number of patients presenting an episode of persistent AF between control group and the two experimental groups
The primary endpoint is the difference in the number of patients presenting an episode of persistent AF (defined as an AF episode lasting more than 30 minutes as documented by scopic and telemetric monitoring) during their hospitalisation. AF is defined by the ESC as RR interval irregularity, absence of repeated P waves, and irregular atrial activations.
The SoC group will be compared to the other two groups of the study. Any episode of persistent AF will be recorded by the usual telemetric monitoring used in post-cardiac surgery monitoring and confirmed by a specialist's review of the trace.
Measured: From enrollment to seven days after the surgery
Secondary outcomes (7)
Difference in the number of patients presenting an episode of persistent AF between the two experimental groups
Difference in the number of patients presenting an episode of persistent AF during the postoperative follow-up hospitalization after cardiac surgery, of the preventive treatment bundle (associating colchicine, amiodarone, and posterior pericardial window) compared to the posterior pericardial window alone.
Measured: From enrollment to seven days after the surgery
Impact on the duration of hospitalisation
Duration of hospitalisation in days. Comparison of the preventive treatment bundle with the standard of care. Comparison of the posterior pericardial window alone compared to the standard of care. Comparison of the preventive treatment bundle compared to the posterior pericardial window alone.
Measured: From enrollment until end of hospitalisation (maximum of 3 years)
Incidence of pericardial effusion requiring surgical correction during the hospitalization
Efficacy to decrease the incidence of pericardial effusion (requiring surgical correction) during hospitalization:
- Comparison of the preventive treatment bundle with the standard of care.
- Comparison of the posterior pericardial window alone compared to the standard of care.
- Comparison of the preventive treatment bundle compared to the posterior pericardial window alone.
Measured: From enrollment until end of hospitalisation (maximum of 3 years)
Incidence of the introduction of anticoagulants during hospitalization
Efficacy to decrease the number of patients for whom treatment with anticoagulants is necessary during hospitalization (in the case of a POAF episode of 48h or more or in case of POAF recurrence):
- Comparison of the preventive treatment bundle with the standard of care.
- Comparison of the posterior pericardial window alone compared to the standard of care.
- Comparison of the preventive treatment bundle compared to the posterior pericardial window alone
Measured: From enrollment until end of hospitalisation (maximum of 3 years)
Incidence of cardiac conduction disorders requiring temporary electro-training during hospitalization
Efficacy to reduce the occurrence of cardiac conduction disorders during hospitalization:
- Comparison of the preventive treatment bundle with the standard of care.
- Comparison of the posterior pericardial window alone compared to the standard of care.
- Comparison of the preventive treatment bundle compared to the posterior pericardial window alone.
Measured: From enrollment until end of hospitalisation (maximum of 3 years)
Cardiac health of patients at 1 year
General health state of patients as well as electrocardiogram and current treatments for cardiac disorders (based on data from standard follow-up by the patient's cardiologist)
- Comparison of the preventive treatment bundle with the standard of care.
- Comparison of the posterior pericardial window alone compared to the standard of care.
- Comparison of the preventive treatment bundle compared to the posterior pericardial window alone
Measured: At 1 year post-surgery
Cardiac health of patients at 3 years
General health state of patients as well as electrocardiogram and current treatments for cardiac disorders (based on data from standard follow-up by the patient's cardiologist)
- Comparison of the preventive treatment bundle with the standard of care.
- Comparison of the posterior pericardial window alone compared to the standard of care.
- Comparison of the preventive treatment bundle compared to the posterior pericardial window alone
Measured: At 3 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 636 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887022
- Sponsor's protocol ID
- 2025-523209-14-00
- Other IDs
- 2025-523209-14-00, 2025
- Acronym
- PREV-AF
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter and Randomized Study on Atrial Fibrillation Prevention After Cardiac Surgery With a 3-Way Comparison Between Standard of Care, Posterior Pericardiotomy and a Treatment Bundle (Colchicine, Amiodarone and Posterior Pericardiotomy)
- ClinicalTrials.gov ID
- NCT07887022
- Acronym / sponsor ID
- PREV-AF / 2025-523209-14-00
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- prevention, atrial fibrillation, colchicine, amiodarone, posterior pericardiotomy, auricular fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 636 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 21 Oct 2026 (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 goal of this clinical trial is to learn if a bundle of three treatments can prevent atrial fibrillation, a heart rhythm disorder often observed in adults following heart surgery. Atrial fibrillation is associated with increased risks of stroke and heart failure. The bundle consists of two drugs (colchicine and amiodarone) as well as a simple surgical technique called posterior pericardiotomy. The main question it aims to answer is whether this bundle can reduce the incidence of atrial fibrillation after heart surgery.
Researchers will compare the results from this bundle of treatment to two other groups, one treated only with the posterior pericardiotomy and one treated following standard of care.
Participants, depending on their group, may receive colchicine and amiodarone before and just after heart surgery and the posterior pericardiotomy will be performed at the same time as the heart surgery.
Detailed description
Atrial fibrillation (AF) is an irregular and often very rapid heart rhythm, and it is one of the most commonly encountered heart conditions. AF is defined as a supraventricular arrhythmia with uncoordinated atrial activation, which results in a loss of effective atrial contraction (Van Gelder et al. 2024). AF has been associated with increased risks of stroke and heart failure as well as subclinical cerebral damage (potentially leading to vascular dementia), and thromboembolism to every other organ (Van Gelder et al. 2024). POAF is associated with worsening prognostics as it is linked with prolonged hospital stay, haemodynamic instability, an increased risk of stroke, and increased mortality (Maesen et al. 2012; Caldonazo et al. 2023). The strongest predictor of POAF is increasing age, other predictors are more difficult to define as they are not always significantly correlated with POAF (Maesen et al. 2012).
Studies have assessed many different medical strategies to decrease POAF's incidence after cardiac surgery, resulting in a wide variety of treatments and prevention strategies that do not necessarily have robust proof of a positive effect. The goal of this study is to obtain more conclusive proof on the efficacy and safety of a treatment bundle in preventing POAF's incidence. This bundle will include treatment with amiodarone and colchicine as well as a surgical procedure (posterior pericardiotomy).
Amiodarone is an anti-arrhythmia treatment that has proven effective in POAF's prevention (Chatterjee et al. 2013). However, in Europe, it is rarely used for PAOF's prevention due to adverse events, including heart conduction disorders (Emiola et al. 2024). Low doses of amiodarone over a short period of time could help prevent POAF while decreasing the incidence of adverse events (Van Gelder et al. 2024). Amiodarone is sometimes used in combination with beta-blockers (Auer et al. 2004; Polintan et al. 2023). However, we have recently demonstrated that the use of beta-blockers during cardiac surgery can increase the incidence of postoperative acute renal failure and might not prevent POAF. Their use should remain cautious peri-operatively in the context of these high-risk surgeries (Guinot et al. 2024; Fischer et Guinot 2024).
Colchicine has an anti-inflammatory and anti-arrhythmic action by inhibiting microtubular depolymerization of the calcium channels involved in tachyarrhythmias. A recent meta-analysis highlights its efficacy in preventing POAF (Agarwal et al. 2023) and in some cases even for short treatment durations (5 days peri-operatively) (Shvartz et al. 2022).
The posterior pericardial window is a quick surgical technique (<5 min) that helps drain pericardial fluid into the left pleura by making a 4-5 cm incision in the posterior pericardium opposite the left inferior pulmonary vein, towards the diaphragm, and parallel to the phrenic nerve. The advantage of this technique is that it avoids the accumulation of fluid opposite the left atrium, which can induce POAF, especially as postoperative pericardial fluid is itself highly inflammatory (Abouarab et al. 2017). A recent randomized study showed a significant reduction in POAF's incidence in patients who benefited from this procedure compared to patients who did not (Gaudino et al. 2021). However, no other randomized study has yet confirmed these results.
The originality of this study project lies in the evaluation of a "preventive treatment bundle" to reduce the incidence of POAF after cardiac surgery compared to the standard of care (which includes treatment with amiodarone and beta-blockers in case of POAF). This study will also compare the use of a posterior pericardial window with the standard of care. This will help to differentiate the impact of the posterior pericardial window versus the preventive treatment with amiodarone and colchicine on the incidence of POAF.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SoC) | No intervention | – |
| Posterior pericardiotomy alone | Active comparator | Procedure: Posterior pericardiotomyPatients will be treated following standard of care with the addition of the posterior pericardiotomy performed during the planned surgery. |
| Treatment bundle | Experimental | Drug: Colchicine, Drug: AmiodaronePatients will receive amiodarone and colchicine for prevention and the posterior pericardial window will be performed during the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient (≥ 18 years old) hospitalized for aortic, coronary, ascending aortic or combined valvular heart surgery
- Patient understands French
- Patient affiliated with the French Social Security
- Patient has given a written informed consent
Key exclusion criteria (16 listed)
- Patient who are part of a vulnerable population (including pregnant women and patients under guardianship or trusteeship)
- Current treatment by amiodarone or colchicine
- Patient who will receive emergency surgery (< 24h)
- Patient who will receive mitral or tricuspid valve surgery
- Patient who will receive Transcatheter Aortic Valve Implantation (TAVI)
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 |
|---|---|---|
| ColchicineThe dosage will be 1mg PO on D-1, followed by 1mg/day PO from D1 to D5 (stopped in case of diarrhoea). This represents a maximum total dose of 6mg. If the patient is older than 75 years old or if the patient's weight is less than 70kg, then the daily dosage will be 0.5mg. | Drug | Treatment bundle |
| Amiodarone400mg/day per os (PO) on D-1 and D0, followed by 200mg/day PO from D1 to D5 if the heart rate is equal or superior to 70 beats/min. If the heart rate is inferior to 70 beats/min then the treatment will not be given. This represents a maximum total dose of 1800mg. | Drug | Treatment bundle |
| Posterior pericardiotomyThe procedure will be done similarly to previously published studies (Mulay et al. 1995; Gaudino et al. 2021). The left pleural space will be entered through the pre-existing median sternotomy. A 4-cm incision will be made posterior to the phrenic nerve in a parallel and longitudinal fashion extending from the left inferior pulmonary vein to the diaphragm. We will use the tip of the mediastinal tube that is placed in all cardiac surgery patients (instead of an additional chest tube) for drainage of the left-sided pleura so that patients in the treatment group will not have a higher level of postoperative pain or discomfort. The estimated additional surgery time is less than 5 min (Abouarab et al. 2017). | Procedure or surgery | Posterior pericardiotomy alone |
Primary outcome
Difference in the number of patients presenting an episode of persistent AF between control group and the two experimental groups
Time frame: From enrollment to seven days after the surgery
The primary endpoint is the difference in the number of patients presenting an episode of persistent AF (defined as an AF episode lasting more than 30 minutes as documented by scopic and telemetric monitoring) during their hospitalisation. AF is defined by the ESC as RR interval irregularity, absence of repeated P waves, and irregular atrial activations. The SoC group will be compared to the other two groups of the study. Any episode of persistent AF will be recorded by the usual telemetric monitoring used in post-cardiac surgery monitoring and confirmed by a specialist's review of the trace.
7 secondary outcomes
Difference in the number of patients presenting an episode of persistent AF between the two experimental groups
Time frame: From enrollment to seven days after the surgery
Impact on the duration of hospitalisation
Time frame: From enrollment until end of hospitalisation (maximum of 3 years)
Incidence of pericardial effusion requiring surgical correction during the hospitalization
Time frame: From enrollment until end of hospitalisation (maximum of 3 years)
Incidence of the introduction of anticoagulants during hospitalization
Time frame: From enrollment until end of hospitalisation (maximum of 3 years)
Incidence of cardiac conduction disorders requiring temporary electro-training during hospitalization
Time frame: From enrollment until end of hospitalisation (maximum of 3 years)
Cardiac health of patients at 1 year
Time frame: At 1 year post-surgery
Cardiac health of patients at 3 years
Time frame: At 3 years post-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 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine, Amiodarone and Posterior pericardiotomy in people with Atrial Fibrillation (AF), run by Elsan at 3 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 4 inclusion and 16 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 21 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 3 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Charlène Py (+33556003048, charlene.py@elsan.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the number of patients presenting an episode of persistent AF between control group and the two experimental groups (time frame: From enrollment to seven days after the surgery). 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 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.