Covert Injection was approved to treat atrial fibrillation and atrial flutter, two common arrhythmias that cause irregular contractions of the heart. Covert is indicated for the rapid conversion of atrial fibrillation or atrial flutter to normal sinus rhythm.
The results of two, large, placebo-controlled, double-blind and randomized clinical trials demonstrated that, compared with placebo, Corvert Injection successfully and rapidly converted atrial fibrillation and flutter to normal rhythm. In a third study conducted in Europe, Covert compared favorably with another intravenous antiarrhythmic agent currently unavailable in the United States
A small number of subjects (1.7%) treated with Covert developed sustained polymorphic ventricular tachycardia (PVT), an arrhythmia of the ventricles. This side effect is common to antiarrhythmic agents used to treat atrial fibrillation and flutter and is potentially life threatening. However, the small number of subjects who developed PVT were successfully treated with electrical cardioversion.
The atria are the upper chambers of the heart. They receive blood from the body and lungs; they load the ventricles, the primary pumping chambers of the heart; and they regulate, with electrical currents, the pace of contraction (heart beat) for the entire heart. Atrial fibrillation and flutter are common arrhythmias that cause irregular contractions of the heart. Alone, the conditions are not considered life-threatening. But they can lead to decreased cardiac output, congestive heart failure and low blood pressure in some subjects. Atrial fibrillation is a risk factor for embolic stroke. Prevalence of these arrhythmias increases with age. Atrial fibrillation affects 0.4% of Americans under the age of 60 and 2% to 4% of those over 60 years of age.
Electrical cardioversion is the primary treatment option for subjects who would benefit from rapid conversion of atrial fibrillation and flutter to normal sinus rhythm. The procedure, which delivers an electrical current to the heart, requires anesthesia to minimize subject discomfort.