Restoring Sinus Rhythm Using Dual-Shock Technique in Patients With Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional Electrical Cardioversion, Dual-shock Electrical Cardioversion.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF), Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Restoring Sinus Rhythm Using DUAL-electrical SHOCK Technique: the DUAL-SHOCK Trial
Overview
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.
Interventions
- Procedure Conventional Electrical Cardioversion
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 wil - Procedure Dual-shock Electrical Cardioversion
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
Primary outcome measures
- Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock [Time frame: First minute after first shock delivery]
- Primary Safety Outcome - Adverse events during the procedure [Time frame: Before patient are discharged]
Secondary outcome measures (4)
- Overall Procedural Sucess [Time frame: The end of the procedure]
- Overall Intervention-Specific Success [Time frame: First minute after shock delivery]
- Total Energy Delivered [Time frame: End of the procedure]
- Sub-acute procedural success [Time frame: At 30 (25-35) days after the procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07560644 · 25-129