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
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