Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) (POWER-AF)
Pulsed Field Ablation for Atrial Fibrillation Including Posterior Wall and Linear Ablation: A Randomized Controlled Trial of Safety and Efficacy (POWER-AF)
Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice. As of 2019, there were approximately 59.7 million patients with AF worldwide, including atrial flutter (AF). Atrial fibrillation can significantly increase the risks of stroke, thromboembolism and heart failure in patients, seriously affecting their quality of life.
Catheter ablation is the main means for rhythm control in patients with atrial fibrillation. A large number of clinical studies have confirmed the effectiveness and safety of catheter ablation for atrial fibrillation. It is significantly superior to drug treatment in maintaining sinus rhythm and can significantly improve symptoms and quality of life.
Pulsed electric field ablation (PFA) is a novel ablation method that utilizes pulsed electric fields as energy. It uses multiple short-duration and high-voltage electrical pulses to release ablation energy, selectively causing myocardial cells to rupture and die. However, it has no obvious damaging effect on blood vessels, nerves, and tissues around the heart, such as the lungs, esophagus, and phrenic nerve.
This trial was designed based on the advantage of the characteristic that PFA does not damage the esophagus, confining the damage to the posterior half of the left atrium and the circumferential isthmus of the mitral valve. While improving the ablation success rate, it is possible to protect the function of the left atrium. This study aims to verify the superiority of the new rhythm control strategy in a large-scale population by launching a prospective randomized controlled trial.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Yan Yao
- Número de telefone: 010-88392405
- E-mail: ianyao@263.net.cn
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100037
- Recrutamento
- National Cardiovascular Diseases Center, Fuwai Hospital
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Contato:
- Yao Yan
- Número de telefone: 010-88392405
- E-mail: ianyao@263.net.cn
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Atrial fibrillation patients who will accept catheter ablation.
- Age ≥ 18.
- Be capable of understanding and signing the informed consent form.
Exclusion Criteria:
- Have contraindications for catheter ablation (such as atrial thrombosis, decompensated heart failure, etc.)
- Have accepted catheter ablation before.
- Myocardial infarction, or any cardiac interventional/surgery has been performed within 3 months.
- Had a stroke or transient ischemic attack within 6 months.
- Allergy to iodine contrast agents.
- Participate in clinical trials related to other drugs or devices.
- Pregnant women, lactating women, or women with plans to become pregnant shortly.
- Active stage of infection.
- Secondary atrial fibrillation, such as combined with rheumatic heart disease, hypertrophic cardiomyopathy, etc.
- Patients who do not agree to be enrolled or are unable to cooperate to complete the study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Pulsed Field Ablation Arm
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Left atrial electrical anatomical mapping modeling was performed using a high-density mapping catheter, and ablation was carried out using a pulsed field catheter.
For patients with paroxysmal atrial fibrillation, bilateral large loop pulmonary vein isolation combined with left posterior atrial wall ablation is performed.
For patients with persistent atrial fibrillation, bilateral large loop pulmonary vein isolation, left posterior atrial wall ablation, and mitral valve isthmus ablation are performed.
For patients with atrial fibrillation rhythm after ablation, intravenous ibutilide/electrical cardioversion was used for conversion, and the specific conversion strategy was consistent with that of the radiofrequency ablation group.
Pulsed field ablation will be performed using a pulsed field ablation system for pulmonary vein isolation and additional ablation as clinically indicated.
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Comparador Ativo: Radiofrequency Ablation Arm
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Radiofrequency ablation will be performed using a saline perfusion catheter, and the ablation catheter was empirically selected by the surgeon.
For patients with paroxysmal atrial fibrillation, circumferential pulmonary vein isolation is performed.
For patients with persistent atrial fibrillation, circumferential pulmonary vein isolation combined with individualized linear ablation is performed.
For those whose ablation of all the established routes has been completed but whose sinus rhythm has not been restored, intravenous ibulide is used for drug cardioversion.
If the drug fails to counteract, perform two-phase alternating current cardioversion.
Cardioversion can be repeated at most twice.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Recurrence of atrial fibrillation within 12 months after ablation
Prazo: 12 months after ablation
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Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds after the post-ablation blanking period, documented by 12-lead electrocardiogram, Holter monitoring, event recorder, or other rhythm monitoring methods.
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12 months after ablation
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in atrial fibrillation burden from baseline to 12 months after ablation
Prazo: Baseline and 12 months after ablation
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Change in atrial fibrillation burden among participants with paroxysmal atrial fibrillation.
Atrial fibrillation burden is defined as the percentage of monitored time spent in atrial fibrillation during rhythm monitoring.
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Baseline and 12 months after ablation
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Change in left ventricular ejection fraction from baseline to 12 months after ablation
Prazo: Baseline and 12 months after ablation
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Change in left ventricular ejection fraction measured by echocardiography.
Unit of Measure: Percentage points
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Baseline and 12 months after ablation
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Change in 36-Item Short Form Health Survey physical component summary score from baseline to 12 months after ablation
Prazo: Baseline and 12 months after ablation
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Change in quality of life assessed using the physical component summary score of the 36-Item Short Form Health Survey.
Scores range from 0 to 100, with higher scores indicating better physical health status.
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Baseline and 12 months after ablation
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All-cause mortality within 12 months after ablation
Prazo: 12 months after ablation
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Death from any cause during the 12-month follow-up period after ablation.
Unit of Measure: Number or percentage of participants
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12 months after ablation
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Change in 36-Item Short Form Health Survey mental component summary score from baseline to 12 months after ablation
Prazo: Baseline and 12 months after ablation
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Change in quality of life assessed using the mental component summary score of the 36-Item Short Form Health Survey.
Scores range from 0 to 100, with higher scores indicating better mental health status.
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Baseline and 12 months after ablation
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
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Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
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Outros números de identificação do estudo
- 2024-2569
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