Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems (MICROPFA)
21 de maio de 2026 atualizado por: Ivan Zeljkovic
Cerebral Microembolization During Pulmonary Vein Isolation: a Randomized Comparison of Different Pulsed Field Ablation Systems
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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
100
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Ivan Zeljković, PhD,MD
- Número de telefone: +385917823289
- E-mail: ivanzeljkov@gmail.com
Estude backup de contato
- Nome: Mihovil Santini, MD
- Número de telefone: +385958101778
- E-mail: 023miho@gmail.com
Locais de estudo
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-
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Zagreb, Croácia, 10000
- UH Dubrava
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Investigador principal:
- Ivan Zeljković, MD, Phd
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Subinvestigador:
- Mihovil Santini, MD
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Zagreb, Croácia, 10000
- University Hospital Center Sisters of Charity, Zagreb, Croatia
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: PulseSelect PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the PulseSelect pulsed field ablation system.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
|
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.
|
|
Comparador Ativo: Varipulse PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Varipulse pulsed field ablation system.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
|
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.
|
|
Comparador Ativo: Farapulse PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Farapulse pulsed field ablation system.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
|
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
|
|
Comparador Ativo: Sphere-9 PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Sphere-9 pulsed field ablation system.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
|
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.
|
|
Comparador Ativo: Sphere-360 PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Sphere-360 pulsed field ablation system.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in microembolic signal burden after pulmonary vein isolation
Prazo: During procedure
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Difference in the number of cerebral microembolic signals detected by transcranial Doppler before and after pulmonary vein isolation, expressed as ΔMES, compared between the different pulsed field ablation systems.
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During procedure
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Within-group change in microembolic signal burden
Prazo: During procedure
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Change in the number of cerebral microembolic signals detected by transcranial Doppler before and after pulmonary vein isolation within each pulsed field ablation system group.
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During procedure
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Incidence of new microembolic signals after ablation
Prazo: Immediately after the ablation procedure
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Proportion of participants with newly detected cerebral microembolic signals on transcranial Doppler after pulmonary vein isolation.
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Immediately after the ablation procedure
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Procedure-related clinical neurological events
Prazo: From the start of the ablation procedure through 72 hours after the procedure
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Occurrence of clinically evident neurological events related to the ablation procedure, including stroke or transient ischemic attack.
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From the start of the ablation procedure through 72 hours after the procedure
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Association between procedure duration and ΔMES
Prazo: During procedure
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Association between total procedure duration and the change in cerebral microembolic signal burden before and after pulmonary vein isolation.
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During procedure
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Association between number of ablation applications and ΔMES
Prazo: During procedure
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Association between the number of pulsed field ablation applications delivered during pulmonary vein isolation and the change in cerebral microembolic signal burden before and after the procedure.
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During procedure
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Colaboradores e Investigadores
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Patrocinador
Datas de registro do estudo
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Datas Principais do Estudo
Início do estudo (Estimado)
1 de junho de 2026
Conclusão Primária (Estimado)
1 de janeiro de 2027
Conclusão do estudo (Estimado)
20 de janeiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
14 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de maio de 2026
Primeira postagem (Real)
27 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026/0423-11
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