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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIvan Zeljkovic

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 years or older

Paroxysmal or persistent atrial fibrillation

Indication for catheter ablation with pulmonary vein isolation

Feasibility of transcranial Doppler assessment

Disqualifiers

Recent stroke or transient ischemic attack

Significant cerebrovascular disease preventing reliable transcranial Doppler assessment

Severe valvular or structural heart disease

Pregnancy or breastfeeding

Trial design

Treatments tested in this trial

  • Pulsed field ablation using PulseSelect system
  • Pulsed field ablation using Varipulse system
  • Pulsed field ablation using Farapulse system
  • Pulsed field ablation using Sphere-9 system
  • Pulsed field ablation using Sphere-360 system

Treatment groups

100 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Ivan Zeljkovic

Lead sponsor

University Hospital Dubrava

Sponsor institution

University Hospital Dubrava

Collaborator

University Hospital Center Sisters of Charity, Zagreb, Croatia

Collaborator