SAFE is an international multicentre randomized controlled trial of concomitant surgical atrial fibrillation (AF) ablation in 2000 patients with paroxysmal or persistent AF undergoing cardiac surgery. The intervention under investigation is concomitant surgical AF ablation which is compared to no surgical AF ablation.

Primary outcome: Hospital readmissions for heart failure during 4 years of follow-up.

Secondary outcomes – over the duration of follow-up (unless otherwise specified):

  • Ischemic stroke or systemic arterial embolism
  • Length of ICU and hospital stay
  • Freedom from recurrence of atrial tachycardia
  • Number of days free from admission to healthcare facility for heart failure or presentation to the emergency department for heart failure
  • Mortality
  • Cardiovascular mortality
  • Antiarrhythmic drug use beyond 6 weeks
  • AF ablation after 90 days
  • Quality of life: AF-specific as assessed by the validated Atrial Fibrillation Effect on QualiTy of Life questionnaire (AFEQT); general as assessed by the European quality of life index version 5D (EQ-5D) (for health utilities); and a patient-centric HF questionnaire, the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and annually over the duration of follow-up.
Study Type


Study Design

Randomized controlled trial

NO. of Countries


NO. of Sites


NO. of Participants


Study Period

2022 - 2026



Back To Top