Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems

This prospective, randomized, parallel-group interventional study will compare cerebral microembolization during pulmonary vein isolation between different pulsed field ablation systems in patients with paroxysmal or persistent atrial fibrillation. Adult patients with an indication for catheter ablation will be randomized to one of the included ablation systems: PulseSelect, Varipulse, Farapulse, Sphere-9, or Sphere-360. Microembolic signals will be assessed using transcranial Doppler before and after the procedure. The primary outcome will be the difference in the change in microembolic signal burden, expressed as ΔMES, between the different ablation systems.

NCT Number	NCT07610018
Lead Sponsor	Ivan Zeljkovic Collaborators: University Hospital Dubrava, University Hospital Center Sisters of Charity, Zagreb, Croatia
Conditions	Ablation of Arrhythmia's
Enrollment	100 participants
Start Date	2026-06-01
Primary Completion	2027-01-01 (estimated)
Study Completion	2027-01-20 (estimated)
Updated on ClinicalTrials.gov	2026-05-27