Restoring Sinus Rhythm Using DUAL-electrical SHOCK Technique: the DUAL-SHOCK Trial
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Martín Negreira Caamaño
- Enrollment
- 177
- Primary Endpoint
- Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Conventional Electrical Cardioversion
Conventional ECV with single pad configurataion in antero-lateral or antero-posterior location. Energy deliver: 200J
Intervention: Conventional Electrical Cardioversion (Procedure)
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.
Intervention: Dual-shock 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.
Intervention: Dual-shock Electrical Cardioversion (Procedure)
Outcomes
Primary Outcomes
Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock
Time Frame: 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
Time Frame: Before patient are discharged
Ocurrence of any complication during the ECV. Arrhythmic recurrences of atrial fibrillation will not be considered as complications.
Secondary Outcomes
- 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)
Investigators
Martín Negreira Caamaño
MD, PhD
Hospital Universitario Getafe