Design and rationale of a multicenter randomized trial assessing strategies for catheter ablation of persistent atrial fibrillation- The STAR AF 3 trial.

RATIONALE: Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation procedures for the treatment of atrial fibrillation (AF). However, the success rates of PVI are limited for patients with persistent AF. Yet, the optimal ablation strategy beyond PVI alone in patients with persistent AF remains to be established.

STUDY DESIGN AND OBJECTIVES: The STAR AF 3 trial is an international multicenter prospective, single-blind, blinded endpoint, clinical trial that includes patients with persistent AF of more than 3 months duration referred for a first catheter ablation procedure. Enrollment will occur at 33 centers in Europe, Canada, Australia, USA and Japan. The aim of this study is to compare the strategy of PVI alone with two strategies that add ablation to PVI: PVI+drivers ablation and PVI+posterior wall isolation. Patients will be equally randomized into one of these three ablation strategies. Patients will be followed up for 18 months. The primary endpoint will be the time to first recurrence of documented atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 days and 18 months after a single ablation procedure. An atrial tachyarrhythmia will qualify as a recurrence if it lasts 30 s or longer and is documented by 12-lead electrocardiogram, electrocardiographic rhythm strips, or transtelephonic monitor recordings. Although a post-ablation blanking period of 3 months will be observed, a repeat left atrial ablation procedure done at any time will also qualify as a primary endpoint event. Enrollment is completed and a total of 617 patients have been recruited into the trial. The trial is registered at the Clinicaltrials.gov (NCT04428944) CONCLUSIONS: The STAR AF 3 trial is a large multicenter randomized trial assessing the optimal ablation strategy for patients with persistent AF.