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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Electrical Cardioversion | Active Comparator | Conventional ECV with single pad configurataion in antero-lateral or antero-posterior location. Energy deliver: 200J |
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| Dual-Shock 400J | Experimental | ECV with dual shock technique. Double pad configuration with electrodes both in antero-lateral and antero-posterior location. Total energy deliver: 400J. |
|
| Dual-Shock 200J | Experimental | ECV with dual shock technique. Double pad configuration with electrodes both in antero-lateral and antero-posterior location. Total energy deliver: 200J. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Electrical Cardioversion | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock | 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 | Ocurrence of any complication during the ECV. Arrhythmic recurrences of atrial fibrillation will not be considered as complications. | Before patient are discharged |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Procedural Sucess | Percentage of patients achieving stable sinus rhythm after any number of shocks | The end of the procedure |
| Overall Intervention-Specific Success | Number of successful shocks / Overall delivered shock within the same pad configuration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martín Negreira-Caamaño, MD, PhD | Contact | +34 916839360 | martin.negcam@gmail.com |
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Study protocol will be sent for publication
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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.
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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.
|
| Dual-shock Electrical Cardioversion | Procedure | 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. |
|
| First minute after shock delivery |
| Total Energy Delivered | Total energy administered (J) before the procedure is completed | End of the procedure |
| Sub-acute procedural success | Percentage of patients in sinus rhythm at 30 days after the ECV | At 30 (25-35) days after the procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |