Restoring Sinus Rhythm Using Dual-Shock Technique in Patients With Atrial Fibrillation (DUAL-SHOCK)
Restoring Sinus Rhythm Using DUAL-electrical SHOCK Technique: the DUAL-SHOCK Trial
The goal of this clinical trial is to assess the efficacy and acute safety of the dual electrical cardioversion (ECV) technique compared with the conventional ECV in patients with persistent atrial fibrillation. The main question it aims to answer are:
- Is dual ECV more effective than conventional ECV to achieve sinus rhythm restoration?
- Is dual ECV safe compared with conventional ECV?
- Which are the main factors associated with cardioversion success?
Researchers will compare a dual ECV technique with 400J with dual ECV with 200J and conventional ECV.
Participants will be randomized to one ECV configuration. The primary efficacy endpoint will be considered the percentage of patients with successful cardioversion with the first shock. The coprimary safety endpoint will be the occurrence of adverse events during ECV.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Martín Negreira-Caamaño, MD, PhD
- Número de teléfono: +34 916839360
- Correo electrónico: martin.negcam@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Diagnosis of persistent AF.
- Effective anticoagulation for at least 3 weeks prior to the procedure or exclusion of intra-atrial thrombus by transesophageal echocardiography within the last 24 hours.
- Informed consent obtained.
Exclusion Criteria:
- Long-standing persistent atrial fibrillation (more than 1 year of uninterrupted AF rhythm).
- Emergency indication (hemodynamic instability).
- Cardiac defibrillation following catheter ablation procedures. Cardiac defibrillation performed during the same procedure will be permitted if it is carried out prior to ablation.
- Pregnancy.
- Age <18 years or legal incapacity.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Conventional Electrical Cardioversion
Conventional ECV with single pad configurataion in antero-lateral or antero-posterior location.
Energy deliver: 200J
|
Defibrillation pads will be placed in the anteroposterior or anterolateral position. An initial biphasic shock of 200 J will be delivered. If sinus rhythm is not restored, a second dual shock of 400 J (crossover) will be administered. The procedures will be performed in the designated area for such procedures at each center, under deep sedation in accordance with each center's standard protocols. The choice of medication used for sedation will be at the investigator's discretion. All shocks will be delivered using biphasic energy and ECG-synchronized. |
|
Experimental: Dual-Shock 400J
ECV with dual shock technique.
Double pad configuration with electrodes both in antero-lateral and antero-posterior location.
Total energy deliver: 400J.
|
Two pairs of defibrillation pads connected to two different defibrillators will be used. One pair of pads will be placed in the anterolateral position and the second pair in the anteroposterior position. Both defibrillators will be programmed to deliver a biphasic shock of 100 J each (200 J group) or 200 J each (400 J group) simultaneously. The maximum number of CVE attempts per patient will be 3. The procedures will be performed in the designated area for such procedures at each center, under deep sedation in accordance with each center's standard protocols. The choice of medication used for sedation will be at the investigator's discretion. All shocks will be delivered using biphasic energy and synchronized with the QRS complex. |
|
Experimental: Dual-Shock 200J
ECV with dual shock technique.
Double pad configuration with electrodes both in antero-lateral and antero-posterior location.
Total energy deliver: 200J.
|
Two pairs of defibrillation pads connected to two different defibrillators will be used. One pair of pads will be placed in the anterolateral position and the second pair in the anteroposterior position. Both defibrillators will be programmed to deliver a biphasic shock of 100 J each (200 J group) or 200 J each (400 J group) simultaneously. The maximum number of CVE attempts per patient will be 3. The procedures will be performed in the designated area for such procedures at each center, under deep sedation in accordance with each center's standard protocols. The choice of medication used for sedation will be at the investigator's discretion. All shocks will be delivered using biphasic energy and synchronized with the QRS complex. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock
Periodo de tiempo: First minute after first shock delivery
|
Percentage of patients achieving sinus rhythm with the first shock deliver.
Three consecutive beats in sinus rhythm are neccesary to consider sinus rhythm achieved.
|
First minute after first shock delivery
|
|
Primary Safety Outcome - Adverse events during the procedure
Periodo de tiempo: Before patient are discharged
|
Ocurrence of any complication during the ECV.
Arrhythmic recurrences of atrial fibrillation will not be considered as complications.
|
Before patient are discharged
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Procedural Sucess
Periodo de tiempo: The end of the procedure
|
Percentage of patients achieving stable sinus rhythm after any number of shocks
|
The end of the procedure
|
|
Overall Intervention-Specific Success
Periodo de tiempo: First minute after shock delivery
|
Number of successful shocks / Overall delivered shock within the same pad configuration.
|
First minute after shock delivery
|
|
Total Energy Delivered
Periodo de tiempo: End of the procedure
|
Total energy administered (J) before the procedure is completed
|
End of the procedure
|
|
Sub-acute procedural success
Periodo de tiempo: At 30 (25-35) days after the procedure
|
Percentage of patients in sinus rhythm at 30 days after the ECV
|
At 30 (25-35) days after the procedure
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25-129
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
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