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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Martín Negreira-Caamaño, MD, PhD
- Número de telefone: +34 916839360
- E-mail: martin.negcam@gmail.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Procedural Sucess
Prazo: 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
Prazo: 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
Prazo: End of the procedure
|
Total energy administered (J) before the procedure is completed
|
End of the procedure
|
|
Sub-acute procedural success
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 25-129
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