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
- Diseases
- Atrial fibrillation
- 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
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UH Dubrava Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| University Hospital Center Sisters of Charity, Zagreb, Croatia Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.