Study of Pulsed Field Ablation and Left Atrial Appendage Closure Using FARAPULSE PFA System and WATCHMAN FLX Devices in Patients with Atrial Fibrillation in Europe, Middle East, and Africa

What this Trial Is About

This research aims to gather real-world clinical data on patients undergoing atrial fibrillation AF ablation using the FARAPULSE Pulsed Field Ablation PFA System combined with left atrial appendage closure LAAC using the WATCHMAN FLX Pro or WATCHMAN FLX device in one interventional procedure. The study focuses on patients who are clinically indicated for both AF ablation and LAAC as determined by their doctors medical judgment, to better understand the safety and effectiveness of this combined approach. Participants will undergo a single interventional case where AF ablation is performed with the FARAPULSE PFA system along with LAAC using either the WATCHMAN FLX Pro or WATCHMAN FLX device. This study is a single-arm design without randomization or blinding, assessing the combined procedure as part of the patients standard care. The study period extends until December 2029, with primary outcomes measured through 30 days post-procedure. During the study, participants will be monitored for device- or procedure-related serious adverse events within 30 days following the intervention and for acute treatment success during the same timeframe. Participants must provide informed consent and be able to participate in all testing at approved investigation centers. Safety and efficacy are the main focus, with follow-up assessments planned to evaluate outcomes shortly after the procedure.

OPTION-EMEA Clinical Trial