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Randomized Interventional Clinical Trial on the Prevention of Atrial Fibrillation Using Colchicine, Amiodarone And a Posterior Pericardiotomy.
Sponsor: Elsan
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
636
Start Date
2027-01
Completion Date
2032-01
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Colchicine
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.
Amiodarone
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 pericardiotomy
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).
Locations (3)
Clinique Saint-Augustin
Bordeaux, France
Hôpital privé Les Franciscaines
Nîmes, France
Clinique Saint-Pierre
Perpignan, France