Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems
Key facts
- Where
- Zagreb, CroatiaSee the 2 sites
Where in Croatia
- UH DubravaZagreb, CroatiaNo longer taking part
- University Hospital Center Sisters of Charity, Zagreb, CroatiaZagreb, CroatiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ivan Zeljkovic
- Trial code
- NCT07610018
- Record updated
- 27 May 2026
- Original description
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.Read full original descriptionShow less
Cerebral Microembolization During Pulmonary Vein Isolation: a Randomized 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.
Inclusion: Age 18 years or older; Paroxysmal or persistent atrial fibrillation; Indication for catheter ablation with pulmonary vein isolation; Feasibility of transcranial Doppler assessment; Signed informed consent.
Exclusion: Recent stroke or transient ischemic attack; Significant cerebrovascular disease preventing reliable transcranial Doppler assessment; Severe valvular or structural heart disease; Pregnancy or breastfeeding; Inability to receive anticoagulation.