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Not Yet Recruiting NCT07887022

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

Conditions: Atrial Fibrillation (AF)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 636
Sponsor: Elsan

Location: Clinique Saint-Augustin Bordeaux

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.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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 * Patients under treatment with drugs that interact with amiodarone

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07887022). StuddyBuddy aggregates publicly available trial information.