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

NCT07560644 | Not Yet Recruiting Phase 2

• 1 other identifier: 25-129
• Study Type: interventional
• Target: 177
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation (AF); Atrial Fibrillation

Keywords

Atrial fibrillation; Persistant atrial fibrillation; Electrical Cardioversion; Dual-Shock; Sinus Rhythm

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• 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

Study Arms (3)

Conventional Electrical Cardioversion

ACTIVE COMPARATOR

Conventional ECV with single pad configurataion in antero-lateral or antero-posterior location. Energy deliver: 200J

Procedure: Conventional Electrical Cardioversion

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.

Procedure: Dual-shock Electrical Cardioversion

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.

Procedure: Dual-shock Electrical Cardioversion

Interventions

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.

Conventional Electrical Cardioversion

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.

Dual-Shock 200J; Dual-Shock 400J

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of persistent AF.
• Informed consent obtained.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Martín Negreira Caamaño, MD, PhD: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Martín Negreira-Caamaño, MD, PhD

CONTACT

+34 916839360; martin.negcam@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Sponsor.

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 1, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 27, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL