ElectroPulseTM Pulsed Field Ablation System to Treat Atrial Fibrillation

The ElectroPulse Pulsed Field Ablation (PFA) System is a medical device which is used to perform cardiac catheter ablation. The ElectroPulse PFA System consists of the following components: (1) ElectroPulse Pulsed Field Ablation Generator, (2) ElectroPulse Pulsed Field Ablation Catheters, (3) ElectroPulse Pulsed Field Ablation Extension Cable. Index Procedure At index procedure a specialist cardiologist called an electrophysiologist guides a tube called a catheter into the patient heart and uses energy to ablate (i.e. remove) small areas of tissue/nerves responsible for creating the faulty electrical signals that may be causing the irregular heartbeat or atrial fibrillation. The procedure is carried out in an operating room under full anaesthesia and takes 1-4 hours. The procedure preparation and progress are identical to all standard catheter ablation procedures currently performed for atrial fibrillation. During the procedure, the heart will also be ‘mapped’ in a 3D manner, which is a procedure to assess the electrical function of the heart to help the clinical team locate what region of the heart is causing faulty electrical signals in the heart and contributing to the patient's atrial fibrillation. This is done by guiding a commercially available diagnostic catheter (tube) into the heart via a hole in the groin. The experimental component of the study is the use of the ElectroPulse PFA System to undertake the ablation aspect of the procedure. Reablation Procedure If a participant continues to experience atrial fibrillation symptoms within 60 days, and the investigator deems it necessary, the participant will undergo a Remap Procedure to assess whether the initial ablation procedure was successful and new areas of arrhythmia have been formed, or if the initial procedure was unsuccessful. If the cardiac electrophysiologist believes it is required, a commercial device will be used to perform additional ablations. The Remap Procedure is carried out in an operating room under full anaesthesia by a cardiac electrophysiologist (usually the same doctor that perform the Index Procedure) and may take 1-4 hours. Procedural data will be captured in Case Report Forms by the study team, and will include the location and number of ablations performed. Cases will also be video recorded with the consent of the participant for case review in the future. The study will enroll three separate cohorts for regulatory purposes: 1. Persistent AF Cohort – Up to 150 participants diagnosed with persistent atrial fibrillation. 2. Paroxysmal AF Cohort – Up to 150 participants diagnosed with paroxysmal atrial fibrillation. 3. Roll-in Cohort – Up to 100 participants who will be the first treated by each investigator to allow familiarisation with the procedure or device. Although these cohorts are defined separately for regulatory tracking, all participants will be analysed together in the overall study analysis.