Atrial Fibrillation, Atrial Fibrillation (AF)
Conditions
Keywords
Atrial fibrillation, Persistant atrial fibrillation, Electrical Cardioversion, Dual-Shock, Sinus Rhythm
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.
Interventions
PROCEDUREConventional 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 will be delivered using biphasic energy and ECG-synchronized.
PROCEDUREDual-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 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.
Sponsors
Martín Negreira Caamaño, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Intervention model description
Eligible patients will be randomized in a 1:1:1 ratio to one of three treatment groups: standard ECV, dual ECV with 400 J, or dual ECV with 200 J. Patients randomized to receive standard ECV will be further randomized in a 1:1 ratio to receive either an anteroposterior or anterolateral first shock. The initial randomization will be stratified by the presence of obesity (body mass index \>30 kg/m²) and by prior use of antiarrhythmic drugs.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock | 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 | Before patient are discharged | Ocurrence of any complication during the ECV. Arrhythmic recurrences of atrial fibrillation will not be considered as complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Procedural Sucess | The end of the procedure | Percentage of patients achieving stable sinus rhythm after any number of shocks |
| Overall Intervention-Specific Success | First minute after shock delivery | Number of successful shocks / Overall delivered shock within the same pad configuration. |
| Total Energy Delivered | End of the procedure | Total energy administered (J) before the procedure is completed |
| Sub-acute procedural success | At 30 (25-35) days after the procedure | Percentage of patients in sinus rhythm at 30 days after the ECV |
Contacts
CONTACTMartín Negreira-Caamaño, MD, PhD
Outcome results
None listed