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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)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523209-14-00
Enrollment
636
Registered
2026-10-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation

Brief summary

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

Detailed description

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

Interventions

DRUGBISOPROLOL BGR 5 mg
DRUGcomprimé sécable
DRUGHEPARIN GALENIKA 5000 UI/ml solution for injection

Sponsors

Clinique Saint Augustin
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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—

Secondary

MeasureTime frame
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—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 3, 2026