Status:
COMPLETED
Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation
Lead Sponsor:
Medical University of Vienna
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
Atrial fibrillation is the most common cardiac arrhythmia and is expected to affect about 30 million North Americans and Europeans by 2050. Atrial fibrillation is associated with increased cardiovascu...
Eligibility Criteria
Inclusion
- Symptoms of atrial fibrillation since no longer than 48 hours
- Age 18 - 90 years
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01447862
Start Date
October 1 2011
End Date
May 1 2015
Last Update
May 13 2015
Active Locations (1)
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1
Medical University of Vienna, Department of Emergency Medicine
Vienna, Vienna, Austria, A-1090