Persistent atrial fibrillation ablation with contact force sensing catheter: The prospective multicenter PRECEPT Trial

Abstract Background While the safety and effectiveness of catheter ablation of paroxysmal AF is established, there are limited data on outcomes in patients with persistent AF (PsAF). As such, no ablation catheter is currently approved by the FDA for PsAF ablation. Objectives To evaluate the safety and effectiveness of catheter ablation of PsAF using a porous tip contact force (CF)-sensing catheter. Methods The prospective, multicenter, nonrandomized PRECEPT study was conducted at 27 sites in the United States and Canada. Enrollment criteria included documented symptomatic PsAF and nonresponse or intolerance to ≥1 antiarrhythmic drug (Class I or III). Individualized treatment approach was used including pulmonary vein isolation (PVI) with ablation of additional targets permitted at investigators’ discretion. To optimize treatment outcomes, a 3-month post-ablation medication adjustment period followed by a 3-month therapy consolidation period were included. Arrhythmia recurrences were stringently monitored by monthly and symptomatic transtelephonic monitoring, electrocardiogram, and Holter, for up to 15 months post-ablation. Results Of 381 enrolled participants, 348 had the investigational catheter inserted and underwent ablation. The primary adverse event (PAE) rate was 3.8% (14 events in 13 participants). Kaplan Meier analyses estimated the primary effectiveness success rate of 61.7% and clinical success rate of 80.4% at 15 months. Conclusions The results demonstrate the clinical safety and effectiveness of PsAF ablation using CF-sensing technologies. The PAE was within the expected range and similar to those reported in historical studies of paroxysmal AF ablation.