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

Sponsor
Martín Negreira Caamaño, MD, PhD
Study ID
NCT07560644
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
May 1, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Feb 27, 2028

Study Design

Enrollment
177 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Conventional Electrical Cardioversion
    Conventional ECV with single pad configurataion in antero-lateral or antero-posterior location. Energy deliver: 200J
  • Experimental: Dual-Shock 400J
    ECV with dual shock technique. Double pad configuration with electrodes both in antero-lateral and antero-posterior location. Total energy deliver: 400J.
  • Experimental: Dual-Shock 200J
    ECV with dual shock technique. Double pad configuration with electrodes both in antero-lateral and antero-posterior location. Total energy deliver: 200J.

Primary Outcome Measure

Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock [ Time Frame: First minute after first shock delivery ]

Central Contacts

Find similar trials

Nationwide
Atrial fibrillation trialsCardiology trialsHeart disease trials

Related Studies