Global Observational Study of PulseSelect PFA System for Treating Recurrent Paroxysmal or Persistent Atrial Fibrillation with 36-Month Follow-Up

What this Trial Is About

This research aims to observe patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation who are undergoing treatment with the PulseSelect PFA System. The study is a prospective, global, multi-center, non-randomized observational trial designed to monitor outcomes after ablation using this approved device. The trial focuses on evaluating freedom from atrial fibrillation at 36 months post-procedure and safety regarding device or procedure-related adverse events at 6 months. Participants will receive ablation treatment with the commercially available PulseSelect PFA System according to standard hospital care. The study includes follow-up visits at 3, 6, 12, 24, and 36 months after ablation. During the 6, 12, 24, and 36 month visits, participants will undergo 24-hour Holter monitoring to track heart rhythm and other relevant cardiac data. Throughout the 36-month follow-up period, participants will attend scheduled study visits for evaluations including heart rhythm monitoring and safety assessments. Researchers will measure treatment effectiveness by assessing freedom from atrial fibrillation and monitor for any device or procedure-related adverse events. The study involves long-term observation to understand outcomes after treatment with the PulseSelect PFA System.

PULSED AF Post-Approval Study