Preventing Atrial Fibrillation After Heart Surgery With Colchicine, Amiodarone and Posterior Pericardiotomy
Tests colchicine, amiodarone and a surgical technique to prevent atrial fibrillation after heart surgery.
Plain-language title generated from the registry record
Registry title: Randomized Interventional Clinical Trial on the Prevention of Atrial Fibrillation Using Colchicine, Amiodarone And a Posterior Pericardiotomy.
Key facts
- Where
- Bordeaux, Nîmes, and Perpignan, FranceSee the 3 sites
- Phase
- Phase 3
Where in France
- Clinique Saint AugustinBordeaux, FranceNot yet recruiting
- Nouvel Hôpital Privé les Franciscaines - ELSANNîmes, FranceNot yet recruiting
- Clinique Saint-PierrePerpignan, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Elsan
- Trial code
- NCT07887022EU 2025-523209-14-00
- Record updated
- 21 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Patient who will receive emergency surgery (< 24h); Patient who will receive mitral or tricuspid valve surgery; Patient treated with immunosuppressive therapy (for example cyclosporine); Patients under treatment with drugs that interact with amiodarone; Patient with a history of atrial fibrillation; Known hypersensitivity to iodine or amiodarone or any of the excipients listed in the SmPC; 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 Transcatheter Aortic Valve Implantation (TAVI); Patient with active sepsis (endocarditis); Patient who refuses access to his/her personal data for quality control; 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; Breastfeeding.