Initial Safety and Performance of the CellFX® Nano-PFA 360 Catheter Endocardial Ablation System for the Treatment of Atrial Fibrillation
The objective of this study is to demonstrate initial safety and functionality of the CellFX nano-second Pulsed Field Ablation (nsPFA or nano-PFA) 360 Catheter Endocardial Ablation System in treating subjects with paroxysmal atrial fibrillation.
• Subject must be ≥ 18 and ≤ 75 years of age on the day of enrollment
• Subject is willing and capable of providing Informed Consent to undergo study procedures and participate in all examinations and follow-up visits and tests associated with this clinical study
• Subjects with PAF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip
• Subjects who have failed at least one antiarrhythmic drug (AAD; class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as shown by recurrent symptomatic AF, or intolerance to the AAD or AV nodal blocking agents
• Antero-posterior left atrial diameter ≤ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 3 months prior to the procedure
• Left ventricular ejection fraction ≥ 40% as documented by TTE within 12 months prior to the procedure
• Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by the study investigators