A Comparative Study of Percutaneous Pulsed Field Ablation Guided by Ultrasound Alone Versus Fluoroscopy in Patients With Atrial Fibrillation
11 de agosto de 2026 actualizado por: China National Center for Cardiovascular Diseases
This prospective, randomized, multicenter, open-label, non-inferiority interventional study aims to compare the therapeutic efficacy of percutaneous pulsed field ablation (PFA) guided by ultrasound alone versus fluoroscopy in patients with paroxysmal atrial fibrillation (AF).
The success rate of complete electrical isolation of pulmonary veins during the procedure was compared to verify that ultrasound-only guidance is non-inferior to fluoroscopic guidance.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
276
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: MIN TANG, Doctor
- Número de teléfono: 86+ 13810665178
- Correo electrónico: doctordangmin@sina.com
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:
- Adult patients aged 18 to 75 years (including 18 years and 75 years of age).
- Patients diagnosed with paroxysmal atrial fibrillation via 12-lead electrocardiography or ambulatory electrocardiography and scheduled to undergo pulsed field ablation.
- Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.
Exclusion Criteria:
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disorders, or reversible non-cardiac causes;
- Previous history of catheter ablation or cardiac surgery for atrial fibrillation;
- Prior surgical history including patent foramen ovale closure, atrial septal defect closure or repair;
- Implantation of left atrial appendage occluder, mechanical mitral valve prosthesis, or valvuloplasty ring containing metallic materials;
- Concomitant other tachyarrhythmias requiring catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, atrial tachycardia, atrial flutter, Wolff-Parkinson-White syndrome, etc.);
- Persistent atrial fibrillation;
- Left atrial anteroposterior diameter (LAD) > 55 mm on transthoracic echocardiography;
- Women who are pregnant, breastfeeding, or of childbearing age with plans to become pregnant during the clinical trial;
- Current participation in another pharmaceutical or medical device clinical 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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Percutaneous pulsed field ablation performed under ultrasound-only guidance.
Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.
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Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.
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Comparador activo: Pulsed field ablation performed under fluoroscopic guidance
Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.
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Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Success rate of complete electrical isolation of pulmonary veins during the procedure
Periodo de tiempo: Immediately post-procedure
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The proportion of all pulmonary veins maintaining bidirectional block across ablation lines at 20 minutes after ablation completion.
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Immediately post-procedure
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The incidence of complications within 30 days after the procedure
Periodo de tiempo: Within 30 days post-procedure
|
Observe the proportion of complications occurring within 30 days after the procedure.
Such complications include pericardial effusion or cardiac tamponade requiring drainage, phrenic nerve palsy lasting more than 24 hours, severe vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death.
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Within 30 days post-procedure
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Success rate of atrial fibrillation ablation at 12 months post-procedure.
Periodo de tiempo: 12 months post-procedure
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Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation)
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12 months post-procedure
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The proportion of patients admitted to hospital or emergency departments due to atrial fibrillation recurrence within 12 months after the procedure.
Periodo de tiempo: 12 months post-procedure
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The proportion of patients admitted to hospital or emergency departments due to atrial fibrillation recurrence within 12 months after the procedure.
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12 months post-procedure
|
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The proportion of patients who received electrical cardioversion due to atrial fibrillation recurrence within 12 months after the procedure
Periodo de tiempo: 12 months post-procedure
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The proportion of patients who received electrical cardioversion due to atrial fibrillation recurrence within 12 months after the procedure.
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12 months post-procedure
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The proportion of patients undergoing repeat ablation surgery owing to atrial fibrillation within 12 months after the procedure
Periodo de tiempo: 12 months post-procedure
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The proportion of patients undergoing repeat ablation surgery owing to atrial fibrillation within 12 months after the procedure
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12 months post-procedure
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The proportion of patients who resumed antiarrhythmic drug therapy during follow-up after the blanking period
Periodo de tiempo: From the end of the blanking period (within 90 days after catheter ablation) to 12 months post-procedure
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The proportion of patients who resumed antiarrhythmic drug therapy during follow-up after the blanking period
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From the end of the blanking period (within 90 days after catheter ablation) to 12 months post-procedure
|
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Improvement in the total EQ-5D quality-of-life questionnaire score at 12 months post-procedure compared with baseline
Periodo de tiempo: 12 months post-procedure
|
The degree of improvement in total EQ-5D scores at 12 months after ablation relative to baseline levels
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12 months post-procedure
|
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Statistical analysis was performed to evaluate differences in fluoroscopic exposure dose between the two groups.
Periodo de tiempo: Immediately post-procedure
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Statistical analysis was performed to evaluate differences in fluoroscopic exposure dose between the two groups.
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Immediately post-procedure
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Compare the length of hospital stay and postprocedural ICU/CCU stay duration between the two groups.
Periodo de tiempo: through study completion, an average of 1 year
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After hospital discharge, the length of hospital stay for this admission and the duration of postoperative observation in CCU/ICU were compared between the two groups of patients.
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through study completion, an average of 1 year
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Compare the procedural time and DSA fluoroscopy time between the two groups.
Periodo de tiempo: Immediately post-procedure
|
Statistical analyses were performed to compare procedural duration and DSA fluoroscopy duration across the two groups.
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Immediately post-procedure
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Compare the differences in costs between the two groups, including medical equipment costs, personnel costs, and patient hospitalization expenses.
Periodo de tiempo: through study completion, an average of 1 year
|
Total hospitalization costs incurred during this admission were compared between the two groups after hospital discharge.
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through study completion, an average of 1 year
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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 (Estimado)
15 de agosto de 2026
Finalización primaria (Estimado)
28 de febrero de 2029
Finalización del estudio (Estimado)
28 de febrero de 2029
Fechas de registro del estudio
Enviado por primera vez
29 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de agosto de 2026
Publicado por primera vez (Actual)
13 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-3078
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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.
No
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