NCT07887022Not yet recruitingPhase 3
Randomized Interventional Clinical Trial on the Prevention of Atrial Fibrillation Using Colchicine, Amiodarone And a Posterior Pericardiotomy.
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)
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 636 (estimated)
- First submitted
- 15 Oct 2026
- Start date
- Jan 2027
- Primary completion date
- Jan 2029
- Lead sponsor
- Elsan
- Diseases
- Atrial fibrillation
- NCT number
- NCT07887022
- EU CT number
- 2025-523209-14-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 636
- From Jan 2027 to the primary completion date, Jan 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patient with a history of atrial fibrillation
- Known hypersensitivity to iodine or amiodarone or any of the excipients listed in the SmPC
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique Saint Augustin Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| Nouvel Hôpital Privé les Franciscaines - ELSAN Coordinator of this site? Confirm its status | Nîmes | France | Not yet recruiting |
| Clinique Saint-Pierre Coordinator of this site? Confirm its status | Perpignan | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.