Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring recent-onset
Eligibility Criteria
Inclusion Criteria:
- Symptoms of atrial fibrillation since no longer than 48 hours
- Age 18 - 90 years
Exclusion Criteria:
- Need for immediate electrical cardioversion due to hemodynamic instability (hypotension: systolic blood pressure < 100 mmHg, dyspnea, loss of consciousness, unstable angina)
- Moderate to severe heart failure (NYHA III/IV) and patients with previously documented left ventricular ejection fraction (LVEF) ≤ 35%
- History or signs of acute coronary syndromes (acute myocardial infarction, unstable angina) within the last 30 days
- Resting ventricular rate < 80 beats per minute without pace maker back-up
- QT interval of > 440 milliseconds
- Wolff-Parkinson-White (WPW) syndrome
- History of Torsade de pointes arrhythmias or other polymorphic ventricular tachycardias
- Signs of thyreotoxicosis
- Sick Sinus Syndrome or atrioventricular block greater than first degree
- Severe valvular heart disease, clinically meaningful hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis
- Serious disorders of the hepatic, renal (Creatinine > 2.5mg/dl), pulmonary, gastrointestinal, hematologic or central nervous system and serious psychiatric disorders
- Abnormal serum electrolytes despite adequate therapy (especially potassium <3.5 mmol/l or > 5.5 mmol/l)
- Intravenous use of other Class I or III antiarrythmic drugs within 4 hours of study drug application
- Pregnancy (a β-HCG test will be performed in all female subjects apart from women > 50 years and with amenorrhea for at least 12 month (absence of other causes of amenorrhoea)
- Known hypersensitivity to study medication
Sites / Locations
- Medical University of Vienna, Department of Emergency Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Vernakalant
Ibutilide
Initially, patients will be given 3mg/kg Vernakalant in 100ml normal saline over 10min. If atrial fibrillation continues after another 15 minutes of observation, patients will receive a second infusion of Vernakalant (2mg/kg), again over 10 minutes. If the initial rhythm has not converted to sinus rhythm after 2 hours, consented patients will be treated with electrical cardioversion using a standard routine protocol.
Patients will be given 1mg of ibutilide in 100ml normal saline intravenously over 10min. If atrial fibrillation continues after another 10 minutes of observation, patients will receive a second infusion of 1mg ibutilide, again over 10min. If the initial rhythm has not converted to sinus rhythm after 2 hours, consented patients will be treated with electrical cardioversion using a standard routine protocol.