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

Starting soon · Not applicable

Conditions studied: Ablation of Arrhythmia's

In brief

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.

Key facts

Study ID

NCT07610018

Run by

Ivan Zeljkovic

People needed

100

Starts

2026-06-01

Expected to finish

2027-01-20

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UH Dubrava — Zagreb, Croatia
• University Hospital Center Sisters of Charity, Zagreb, Croatia — Zagreb, Croatia

Full record on ClinicalTrials.gov

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