Feasibility Study of the CellFX nsPFA Cardiac Surgery System for Treating Atrial Fibrillation During Cardiac Surgery

What this Trial Is About

Researchers are evaluating the initial safety and effectiveness of the CellFX nsPFA Cardiac Clamp in treating atrial fibrillation during cardiac surgery. This feasibility study involves adult patients who need a concurrent cardiac surgical procedure and aims to perform a box lesion around the four pulmonary veins either alone or as part of a larger surgical ablation set. Participants will undergo left pulmonary vein, roof, and floor ablations to create a left atrial posterior box using the CellFX nsPFA Cardiac Surgery System. This is a single-arm, non-randomized study where all subjects receive this treatment during their scheduled cardiac surgery, such as mitral or aortic valve repair, ascending aortic aneurysm repair, or coronary artery bypass. After surgery, participants will return between 60 and 120 days for a cardiac electrophysiology study with electroanatomical mapping to check the electrical isolation of the pulmonary veins and left atrial posterior wall. Researchers will monitor adverse events within 30 days, assess acute electrical isolation within 24 hours, and track long-term technical success up to 12 months. The study involves follow-up visits and various assessments to evaluate safety and performance over time.

CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation