Restoring Sinus Rhythm Using Dual-Shock Technique in Patients With Atrial Fibrillation

Phase 3Not Yet RecruitingNCT07560644

Martín Negreira Caamaño177 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

177

Conditions

Atrial Fibrillation (AF)Atrial Fibrillation

Interventions

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.

Dual-shock Electrical CardioversionPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Before patient are discharged

Secondary Outcomes

Overall Procedural Sucess

Percentage of patients achieving stable sinus rhythm after any number of shocks

Time frame: The end of the procedure

Overall Intervention-Specific Success

Number of successful shocks / Overall delivered shock within the same pad configuration.

Time frame: First minute after shock delivery

Total Energy Delivered

Total energy administered (J) before the procedure is completed

Time frame: End of the procedure

Sub-acute procedural success

Percentage of patients in sinus rhythm at 30 days after the ECV

Time frame: At 30 (25-35) days after the procedure