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NCT07610018Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 27 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
14 May 2026
Start date
1 Jun 2026
Primary completion date
1 Jan 2027
Lead sponsor
Ivan Zeljkovic
NCT number
NCT07610018

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 1 Jun 2026 to the primary completion date, 1 Jan 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Recent stroke or transient ischemic attack
  • Significant cerebrovascular disease preventing reliable transcranial Doppler assessment
  • Severe valvular or structural heart disease

Other

  • Pregnancy or breastfeeding
  • Inability to receive anticoagulation

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UH Dubrava
Coordinator of this site? Confirm its status
ZagrebCroatiaUnknown status
University Hospital Center Sisters of Charity, Zagreb, Croatia
Coordinator of this site? Confirm its status
ZagrebCroatiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.