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NCT Number: NCT07560644

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

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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

  1. Overall Procedural Sucess

    Time frame: The end of the procedure

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

  2. Overall Intervention-Specific Success

    Time frame: First minute after shock delivery

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

  3. Total Energy Delivered

    Time frame: End of the procedure

    Total energy administered (J) before the procedure is completed

  4. Sub-acute procedural success

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Martín Negreira-Caamaño, MD, PhD

CONTACT

[email protected]

+34 916839360

Sponsors and collaborators

Lead sponsor

Martín Negreira Caamaño, MD, PhD

Other

Registry information

Official study title

Restoring Sinus Rhythm Using DUAL-electrical SHOCK Technique: the DUAL-SHOCK Trial

Acronym: DUAL-SHOCK

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 1, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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