Restoring Sinus Rhythm Using DUAL-electrical SHOCK Technique: the DUAL-SHOCK Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 177
- 主要终点
- Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The outcome of the randomization will be concealed from the patient (single-blind study). All patients will be provided with two sets of defibrillation pads to conceal the intervention they ultimately receive. The analysis of the results will be conducted with the statistical team blinded to the assigned intervention group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Dual-shock Electrical Cardioversion (Procedure)
Conventional Electrical Cardioversion
Conventional ECV with single pad configurataion in antero-lateral or antero-posterior location. Energy deliver: 200J
干预措施: Conventional Electrical Cardioversion (Procedure)
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.
干预措施: Dual-shock Electrical Cardioversion (Procedure)
结局指标
主要结局
Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock
时间窗: 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.
Primary Safety Outcome - Adverse events during the procedure
时间窗: Before patient are discharged
Ocurrence of any complication during the ECV. Arrhythmic recurrences of atrial fibrillation will not be considered as complications.
次要结局
- Overall Procedural Sucess(The end of the procedure)
- Overall Intervention-Specific Success(First minute after shock delivery)
- Total Energy Delivered(End of the procedure)
- Sub-acute procedural success(At 30 (25-35) days after the procedure)
研究者
Martín Negreira Caamaño, MD, PhD
Principal Investigator and Sponsor.
Hospital Universitario Getafe