Multicenter and randomised 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) (PREV-AF)

Condition studied

Atrial fibrillation

Investigational medicinal product(s)

Every trial of Amiodarone Hydrochloride, Bisoprolol and Heparin across our registers →

Eligibility

Primary endpoint

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. As assessed between the surgery and day 7 post-surgery

Endpoint detail

Difference in the number of patients presenting an episode of persistent AF during their hospitalization, Duration of hospitalization in days (starting from D0, the day of the surgery), Incidence of pericardial effusion requiring surgical correction during hospitalization, Incidence of the introduction of anticoagulants during hospitalization in the case of a POAF episode of 48h or more or in case of POAF recurrence, Incidence of cardiac conduction disorders requiring temporary electro-training during hospitalization, Health state of patients as well as electrocardiogram and current treatments for cardiac disorders (based on data from standard follow-up by the patient’s cardiologist), Incidence of gastrointestinal disorders (diarrhoea and abdominal pain), Treatment-emergent adverse events