Safety and Effectiveness of the CellFX® nsPFA Catheter Endocardial Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
The objective of this study is to demonstrate the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Cardiac Catheter Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AF).
• A diagnosis of recurrent drug-resistant symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within seven (7) days of onset, documented by the following:
• i. Physician's note indicating the presence of AF symptoms and at least two (2) episodes of self-terminating AF within six (6) months prior to enrollment
• Age 18 through 85 years old (or older than 18 if required by local law)
• Failure of at least one AAD (class I or III) for AF as evidenced by recurrence of symptomatic AF, or intolerable side effects due to AAD.
• Participant is willing and capable of providing Informed Consent
• Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by study investigators