Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Ablation of Arrhythmia's. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cerebral Microembolization During Pulmonary Vein Isolation: a Randomized Comparison of Different Pulsed Field Ablation Systems
Overview
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.
Detailed description
This study is designed as a prospective, randomized, parallel-group interventional trial conducted at Clinical Hospital Dubrava, Zagreb, Croatia and University Hospital Center Sisters of Charity, Zagreb, Croatia. The study will include adult patients with paroxysmal or persistent atrial fibrillation who have a clinical indication for catheter ablation with pulmonary vein isolation.
Eligible patients will be randomized using a computer-generated randomization sequence to undergo pulmonary vein isolation with one of the following pulsed field ablation systems: PulseSelect, Varipulse, Farapulse, Sphere-9, or Sphere-360. All procedures will be performed according to standard clinical practice, with continuous periprocedural anticoagulation in accordance with current guidelines.
Cerebral microembolization will be assessed using transcranial Doppler. The examination will be performed immediately before the ablation procedure and repeated after the procedure. The presence and number of microembolic signals will be recorded. This will allow assessment of changes in microembolic signal burden within each group and comparison of these changes between different pulsed field ablation systems.
Demographic, clinical, and procedural data will be collected, including age, sex, type of atrial fibrillation, comorbidities, procedure duration, number of ablation applications, and procedural complications. The study will also record procedure-related clinical neurological events.
The primary outcome will be the difference in the change in the number of microembolic signals before and after the procedure, expressed as ΔMES, between the different pulsed field ablation systems. Secondary outcomes will include within-group changes in microembolic signal burden, incidence of new microembolic signals after the procedure, association between procedural parameters and ΔMES, and occurrence of procedure-related neurological events.
Interventions
- Device Pulsed field ablation using PulseSelect system
Pulmonary vein isolation will be performed using the PulseSelect pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure. - Device Pulsed field ablation using Varipulse system
Pulmonary vein isolation will be performed using the Varipulse pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure. - Device Pulsed field ablation using Farapulse system
Pulmonary vein isolation will be performed using the Farapulse pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedu - Device Pulsed field ablation using Sphere-9 system
Pulmonary vein isolation will be performed using the Sphere-9 pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure. - Device Pulsed field ablation using Sphere-360 system
Pulmonary vein isolation will be performed using the Sphere-360 pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure
Primary outcome measures
- Change in microembolic signal burden after pulmonary vein isolation [Time frame: During procedure]
Secondary outcome measures (5)
- Within-group change in microembolic signal burden [Time frame: During procedure]
- Incidence of new microembolic signals after ablation [Time frame: Immediately after the ablation procedure]
- Procedure-related clinical neurological events [Time frame: From the start of the ablation procedure through 72 hours after the procedure]
- Association between procedure duration and ΔMES [Time frame: During procedure]
- Association between number of ablation applications and ΔMES [Time frame: During procedure]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Croatia · 2 centers
- UH Dubrava — Zagreb
- University Hospital Center Sisters of Charity, Zagreb, Croatia — Zagreb
Identifiers
NCT: NCT07610018 · 2026/0423-11