Atrial Fibrillation Clinical Trial
Official title:
Double Sequence External Defibrillation: A Randomized Controlled Trial in Patients With Atrial Fibrillation Refractory to DC Cardioversion
Atrial fibrillation (AF) is a common cardiac arrhythmia that leads to increased risk of heart
failure, hospitalization, thromboembolic events, and death. Restoration of normal heart
rhythm is performed in many patients with AF to improve symptoms. In this study, the
investigators will consider patients who fail 2 or more trials of DC cardioversion as having
refractory AF.
The aim of this study is to assess whether the use of double sequential defibrillation in
patients with refractory AF has a higher success rate in reverting them to a normal heart
rhythm than a third cardioversion.
This is a phase III, randomized controlled, single-centered, superiority trial. All patients
with AF admitted to the coronary care unit (CCU) for DC cardioversion, and refractory to at
least two trials of DC cardioversion will be enrolled. Patients are randomized into two arms:
the first will receive a third trial of DC cardioversion (standard of care) and the second
will receive double sequential external defibrillation.
The resolution of AF by reverting back to normal sinus rhythm is the primary outcome of the
investigators. This will be determined using EKG (electrocardiogram) immediately after DC
cardioversion or double sequential defibrillation.
Patients presenting to the CCU with persistent AF for direct current (DC) cardioversion, who
meet the inclusion criteria and fail to revert to normal sinus rhythm after two DC
cardioversion attempts will be invited for enrollment in the study. No sampling will be
carried out for the sake of this study.
Patients meeting the eligibility criteria will receive double sequential external
defibrillation (DSED) or a third DC cardioversion (standard of care).
DSED is the process of using two defibrillators near simultaneously at their highest allowed
energy setting and aims to treat refractory atrial fibrillation. The first set of pads is
placed in the traditional anterolateral position and the second set can be either placed
adjacent to the first set (antero-lateral) or in the antero-posterior position. Shocks are
then delivered simultaneously or near simultaneously.
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