Cardioversion of paroxysmal atrial fibrillation in the Emergency Department in patients with coronary artery disease without residual ischemia and an left ventricular ejection fraction > 35%
Conditions
Brief summary
The frequency of successful cardioversion to sinus rhythm [from the moment the drug is administered and for up to 6 hours]., The combined frequency of PVCs, NSVT, SVT, bradycardia < 50 bpm, and systolic blood pressure < 90 mmHg [from the moment the drug is administered and up to 6 hours].
Detailed description
The frequency of discharges from the Emergency Department in sinus rhythm [from the moment the drug is administered and for a period of up to 6 hours]., The frequency of successful cardioversion to sinus rhythm [from the moment the drug is administered and for up to 24 hours, 24-hour Holter monitoring]., Time to restoration to sinus rhythm [from the moment the drug is administered and for up to 6 hours]., The frequency of electrical cardioversion [from the moment the drug is administered and for up to 24 hours]., The frequency of arrhythmias: burden of PVCs, NSVT episodes, SVT episodes [from the moment the drug is administered and for up to 24 hours]., The frequency, severity and type of AEs [from the moment the drug is administered and for up to 30 days].
Interventions
DRUGAngoron 150 mg/3 ml amp ενέσιμο διάλυμα
Sponsors
Win Medica Pharmaceutical S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of successful cardioversion to sinus rhythm [from the moment the drug is administered and for up to 6 hours]., The combined frequency of PVCs, NSVT, SVT, bradycardia < 50 bpm, and systolic blood pressure < 90 mmHg [from the moment the drug is administered and up to 6 hours]. | — |
Secondary
| Measure | Time frame |
|---|---|
| The frequency of discharges from the Emergency Department in sinus rhythm [from the moment the drug is administered and for a period of up to 6 hours]., The frequency of successful cardioversion to sinus rhythm [from the moment the drug is administered and for up to 24 hours, 24-hour Holter monitoring]., Time to restoration to sinus rhythm [from the moment the drug is administered and for up to 6 hours]., The frequency of electrical cardioversion [from the moment the drug is administered and for up to 24 hours]., The frequency of arrhythmias: burden of PVCs, NSVT episodes, SVT episodes [from the moment the drug is administered and for up to 24 hours]., The frequency, severity and type of AEs [from the moment the drug is administered and for up to 30 days]. | — |
Countries
Greece
Outcome results
None listed