Boston Scientific Corporation
The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). The main question it aims to answer is: Is the FARAFLEX Mapping and PFA System a safe and effective treatment for patients? Participants will undergo an ablation procedure using the FARAFLEX Mapping and PFA System.
Inclusion Criteria: 1. At least 18 years old (or older if required by local law) 2. Symptomatic, documented, drug-refractory paroxysmal or persistent atrial fibrillation (AF). 3. Willing and capable of providing written informed consent 4. Willing and able to comply with all follow-up assessments and study procedures at an approved investigational site Exclusion Criteria: 1. Any of the following atrial conditions: 1. Left atrial anteroposterior diameter of at least 5.5 cm, or if not available, non-indexed volume greater than 100 mL 2. Any prior atrial endocardial, epicardial, or surg…
Catheter used to perform cardiac electrophysiological mapping and deliver cardiac tissue ablation therapy for the treatment of Atrial Fibrillation.