An interventional study of Anterior-posterior electrode position and Anterior-lateral electrode position in Atrial Fibrillation, sponsored by University of Aarhus. Completed at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
Atrial fibrillation is the most common heart rhythm disorder, and the incidence is rapidly increasing. Cardioversion using an electrical shock (DC-cardioversion) is an important treatment to reduce symptoms and improve patient's quality-of-life. The treatment is performed by applying gel electrodes to the chest. Cardioversion is not always successful, and it is unknown which electrode-position provides the optimal efficacy.
This study aims to compare two electrode positions, which are in clinical use: Anterior-posterior (left front and left back) versus anterior-lateral (right front and left side of the chest).
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 468 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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The anterior electrode is placed in the left parasternal area (precordium). The posterior electrode is placed in the left lower-scapular region with the electrode edge left to the spinal column.
Device: Anterior-posterior electrode position
The anterior electrode is placed in the right parasternal area below the clavicle. The lateral electrode is placed with the center of the electrode in the left mid-axillary line in level with the V6 electrocardiogram electrode.
Device: Anterior-lateral electrode position
Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior electrode position
Also known as: LIFEPAK 20, Physio-Control/Stryker
Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position
Also known as: LIFEPAK 20, Physio-Control/Stryker
Efficacy: First shock success
The primary endpoint will be first shock efficacy, i.e. the proportion of patients in sinus rhythm for at least one minute immediately after an initial shock of 100 J.
Time frame: Immediately after first cardioversion attempt.
Efficacy: Successful cardioversion
The secondary efficacy endpoint will be cardioversion success, i.e. the proportion of patients in sinus rhythm for at least one minute after end of protocol.
Time frame: One minute after cardioversion
Safety: Number of participants with arrhythmic events during and after cardioversion
Secondary safety endpoints will be arrhythmia during and after cardioversion (asystole, transient bradycardia, ventricular arrhythmia, atrioventricular block, recurrence of atrial fibrillation)
Time frame: Within 2 hours after cardioversion (until discharge)
Safety: Number of participants with skin-discomfort, skin burns or itching
Patient-reported peri-procedural discomfort when asked at discharge.
Time frame: Two hours after cardioversion (at discharge)
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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University of Aarhus