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Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) (POWER-AF)

24 de mayo de 2026 actualizado por: China National Center for Cardiovascular Diseases

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1574

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Yan Yao
  • Número de teléfono: 010-88392405
  • Correo electrónico: ianyao@263.net.cn

Ubicaciones de estudio

  • Porcelana
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100037
        • Reclutamiento
        • National Cardiovascular Diseases Center, Fuwai Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Atrial fibrillation patients who will accept catheter ablation.
  2. Age ≥ 18.
  3. Be capable of understanding and signing the informed consent form.

Exclusion Criteria:

  1. Have contraindications for catheter ablation (such as atrial thrombosis, decompensated heart failure, etc.)
  2. Have accepted catheter ablation before.
  3. Myocardial infarction, or any cardiac interventional/surgery has been performed within 3 months.
  4. Had a stroke or transient ischemic attack within 6 months.
  5. Allergy to iodine contrast agents.
  6. Participate in clinical trials related to other drugs or devices.
  7. Pregnant women, lactating women, or women with plans to become pregnant shortly.
  8. Active stage of infection.
  9. Secondary atrial fibrillation, such as combined with rheumatic heart disease, hypertrophic cardiomyopathy, etc.
  10. Patients who do not agree to be enrolled or are unable to cooperate to complete the study

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Pulsed Field Ablation Arm
Procedimiento: Pulsed field ablation
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.
Dispositivo: Pulsed field ablation system
Pulsed field ablation will be performed using a pulsed field ablation system for pulmonary vein isolation and additional ablation as clinically indicated.
Comparador activo: Radiofrequency Ablation Arm
Procedimiento: Radiofrequency ablation alone
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recurrence of atrial fibrillation within 12 months after ablation
Periodo de tiempo: 12 months after ablation
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.
12 months after ablation

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in atrial fibrillation burden from baseline to 12 months after ablation
Periodo de tiempo: Baseline and 12 months after ablation
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.
Baseline and 12 months after ablation
Change in left ventricular ejection fraction from baseline to 12 months after ablation
Periodo de tiempo: Baseline and 12 months after ablation
Change in left ventricular ejection fraction measured by echocardiography. Unit of Measure: Percentage points
Baseline and 12 months after ablation
Change in 36-Item Short Form Health Survey physical component summary score from baseline to 12 months after ablation
Periodo de tiempo: Baseline and 12 months after ablation
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.
Baseline and 12 months after ablation
All-cause mortality within 12 months after ablation
Periodo de tiempo: 12 months after ablation
Death from any cause during the 12-month follow-up period after ablation. Unit of Measure: Number or percentage of participants
12 months after ablation
Change in 36-Item Short Form Health Survey mental component summary score from baseline to 12 months after ablation
Periodo de tiempo: Baseline and 12 months after ablation
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.
Baseline and 12 months after ablation

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

China National Center for Cardiovascular Diseases

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de abril de 2025

Finalización primaria (Estimado)

30 de noviembre de 2027

Finalización del estudio (Estimado)

30 de noviembre de 2028

Fechas de registro del estudio

Enviado por primera vez

8 de mayo de 2025

Primero enviado que cumplió con los criterios de control de calidad

19 de mayo de 2026

Publicado por primera vez (Actual)

22 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de mayo de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2024-2569

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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