Outcomes
death, arrhythmia, ’, atrial arrhythmia, stroke
RECURRENCES, ARRHYTHMIA, ATRIAL ARRHYTHMIA, STROKE, SECONDARY, ATRIAL FIBRILLATION, EVENTS, COMPLICATIONS
The primary endpoint was time to any hospital episode related to treatment for atrial arrhythmia following the 12-week treatment period. We used the term ‘hospital episode’ to include inpatient stay, attendance to an emergency room, or outpatient clinic to be reviewed by an arrhythmia specialist. This reflected the entire healthcare utilization of a patient whose AF was not well controlled. This endpoint would not capture all AF episodes occurring in the patient but transforms the subjectivity of symptomatic recurrences to measurable events requiring healthcare resources.The secondary endpoints were time to death or stroke from any cause, complications caused by procedure or anti-arrhythmic drug, and all hospital episodes resulting in a change in therapy for atrial arrhythmia.Quality-of-life questionnaires [atrial fibrillation Quality of life survey (AFQT) and EQ-5D-5L] were completed at randomization and 1 year.