Randomized Interventional Clinical Trial on the Prevention of Atrial Fibrillation Using Colchicine, Amiodarone And a Posterior Pericardiotomy.

NCT07887022 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: 2025-523209-14-002025
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Atrial Fibrillation (AF)

Keywords

prevention; atrial fibrillation; colchicine; amiodarone; posterior pericardiotomy; auricular fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From enrollment to seven days after the surgery

• Impact on the duration of hospitalisation

  From enrollment until end of hospitalisation (maximum of 3 years)

• Incidence of pericardial effusion requiring surgical correction during the hospitalization

  From enrollment until end of hospitalisation (maximum of 3 years)

• Incidence of the introduction of anticoagulants during hospitalization

  From enrollment until end of hospitalisation (maximum of 3 years)

• Incidence of cardiac conduction disorders requiring temporary electro-training during hospitalization

  From enrollment until end of hospitalisation (maximum of 3 years)

Other Outcomes (2)

• Incidence of gastrointestinal disorders

  From enrollment to the end of follow-up (maximum of 3 years)

• Number of adverse reactions

  From enrollment to the end of follow-up (maximum of 3 years)

Study Arms (3)

Standard of Care (SoC)

NO INTERVENTION

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.

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.

Drug: Colchicine; Drug: Amiodarone

Interventions

Colchicine DRUG

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.

Treatment bundle

Amiodarone DRUG

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.

Treatment bundle

Posterior pericardiotomy PROCEDURE

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).

Posterior pericardiotomy alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Elsan: lead

Study Sites (3)

Clinique Saint-Augustin

Bordeaux, 33200, France

Location

Hôpital privé Les Franciscaines

Nîmes, 30000, France

Location

Clinique Saint-Pierre

Perpignan, 66000, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Colchicine; Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Charlène Py

CONTACT

+33556003048; charlene.py@elsan.care

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2032
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

FR (3)