Multicenter Study of FARAPULSE PFA System to Treat Paroxysmal and Persistent Atrial Fibrillation

What this Trial Is About

Researchers are evaluating the safety and effectiveness of new waveforms delivered using the FARAPULSE142 Pulsed Field Ablation PFA System in patients with Paroxysmal and Persistent Atrial Fibrillation. This multicenter, prospective, single-arm feasibility study aims to assess the initial safety, acute performance, and feasibility of the ablation procedure and waveform delivery in these patients. The study also focuses on understanding lesion durability, procedure efficiency, and patterns of waveform exposure. Participants will receive treatment using the FARAWAVE142 PFA Catheter, which delivers investigational waveforms to isolate pulmonary veins and the posterior wall of the heart. The FARASTAR142 Generator is used alongside the catheter, and the FARADRIVE142 Steerable Sheath facilitates catheter introduction into the heart chambers. This treatment is performed as a single-arm intervention without a comparison group. Throughout the study, participants will undergo assessments to monitor device- or procedure-related adverse events from the day of ablation up to 60 days afterward. The success of the ablation procedure will also be evaluated during the procedure itself. Follow-up activities will include multiple visits and testing to assess safety and performance outcomes. The study is expected to continue until February 2028, with participants involved in follow-up assessments at approved clinical investigational centers.

Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System