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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство 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
• Устройство 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.
• Устройство 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

Первичные конечные точки

• Change in microembolic signal burden after pulmonary vein isolation [Срок оценки: During procedure]

Вторичные конечные точки (5)

• Within-group change in microembolic signal burden [Срок оценки: During procedure]
• Incidence of new microembolic signals after ablation [Срок оценки: Immediately after the ablation procedure]
• Procedure-related clinical neurological events [Срок оценки: From the start of the ablation procedure through 72 hours after the procedure]
• Association between procedure duration and ΔMES [Срок оценки: During procedure]
• Association between number of ablation applications and ΔMES [Срок оценки: During procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Хорватия · 2 центра

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

Идентификаторы

NCT: NCT07610018 · 2026/0423-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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