Pulse Biosciences, Inc.
The primary objective of this Pivotal study is to demonstrate the safety and effectiveness of the Pulse Biosciences nsPFA™ Cardiac Surgery System in treating atrial fibrillation during concomitant cardiac surgical procedures.
The study design is a prospective, multicenter, non-randomized single arm study. Eligible adult subjects with paroxysmal or persistent/longstanding persistent AF who are eligible to participate will undergo a concomitant cardiac surgical procedure with CellFX nsPFA Cardiac Surgery System ablation and left atrial appendage exclusion or removal. The left atrial wall isolation will include left and right pulmonary vein isolation as well as isolation of the left atrial posterior wall through left atrial roof and floor lesions. The left atrial posterior wall isolation (PWI) can be formed by either…
Inclusion Criteria: * Subject must be between 18 and 85 years of age * Subject is willing and capable of providing Informed Consent to undergo study procedures which include the potential for surgical AF ablation, and completion of follow-up visits as specified in the clinical study protocol * Subject has history of documented paroxysmal atrial fibrillation (AF that is intermittent and terminates within ≤ 7 days of onset) or persistent/longstanding persistent atrial fibrillation (AF that is continuous and sustains for \> 7 days and requires intervention) within one year prior to enrollment. D…
Participants will receive cardiac ablation with the CellFX® nsPFA™ Cardiac Clamp
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