Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation (AnPAF)
Paroxysmal Atrial Fibrillation
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring atrial fibrillation, paroxysmal, cardioversion, antazoline
Eligibility Criteria
Inclusion Criteria:
- Written informed consent for participating in the study and written standard version of informed consent for cardioversion accepted in Institute of Cardiology, Warsaw, Poland
- Age above 18 and good general condition
- Potassium level over 3.5 mmol/l
- Stable cardio-pulmonary state on enrollment
- In case of unclear history of heart failure or suspicion of impaired left ventricle function echocardiography is indicated prior to enrollment
- A long-term antiarrhythmic drug therapy is allowed
Exclusion Criteria:
- Lack of written informed consent
- Antazoline allergy
- AF related to significant valvular disease
- Clinically significant heart failure or ejection fraction < 55%
- Diastolic blood pressure (BP) < 100mmHg
- History of significant bradyarrhythmia not treated with permanent pacemaker
- QT prolongation over 440ms or QTc (Bazett's formula) over population norm
- Tachycardia > 160'
- Advanced liver or kidney failure
- Acute coronary syndrome, coronary artery by-pass graft, stroke or transient ischemic attack within 30 days before enrollment
- Preexcitation in ECG not treated by radiofrequency ablation of accessory pathway
- Signs and symptoms of ischemia related to AF
- An investigational drug used within 30 days before enrollment
- Pregnancy or breast feeding
Sites / Locations
- Institute of Cardiology, II Dept. of Coronary Heart Disease
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Antazoline
Any patient fulfilling the inclusion criteria will be prepared to pharmacological cardioversion in a standard way comprising of standard baseline 12-lead ECG, continuous ECG monitoring, periodic noninvasive blood pressure monitoring (BP) and iv line. After drug administration the patient will be observed for 1.5 hour after the last dose with exit ECG and BP measure taken at the end of observation. Further treatment of the patient depends on clinical state and follows appropriate clinical guidelines.
Any patient fulfilling the inclusion criteria will be prepared to pharmacological cardioversion in a standard way comprising of standard baseline 12-lead ECG, continuous ECG monitoring, periodic noninvasive blood pressure monitoring (BP) and iv line. After drug administration the patient will be observed for 1.5 hour after the last dose with exit ECG and BP measure taken at the end of observation. Further treatment of the patient depends on clinical state and follows appropriate clinical guidelines.